1 AN INTERNATIONAL INTERNATIONAL TERMINOLOGY UROGYNECOLOGICAL CONTINENCE FOR THE SOCIETY (ICS) CONSERVATIVE ASSOCIATION JOINT AND REPORT (IUGA) ON / THE NON-PHARMACOLOGICAL MANAGEMENT OF FEMALE PELVIC FLOOR DYSFUNCTION Kari Bo^, Helena Frawley^, Bernard Haylen^*, Yoram Abramov^, Fernando Almeida^, Bary Berghmans^, Maria Bortolini^, Chantale Dumoulin^, Mario Gomes^, Doreen McClurg^, Jane Meijlink^, Elizabeth Shelly^#, Emanuel Trabuco^, Caroline Walker^, Amanda Wells^ Standardization and Terminology Committees IUGA* & ICS#, Joint IUGA / ICS Working Group on Conservative Management of Pelvic Floor Dysfunction^ Kari Bo, Physiotherapist, exercise scientist Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo. Norway Helena Frawley, Physiotherapist La Trobe University, Melbourne. Victoria. Australia. Bernard T. Haylen, Urogynaecologist University of New South Wales. Sydney. N.S.W. Australia. Yoram Abramov, Urogynecologist Technion University, Haifa. Israel. 2 Fernando Almeida, Urologist Federal University. San Paolo. Brazil Bary Berghmans, Physiotherapist University of Maastricht, Maastricht. Netherlands. Maria Bortolini, Urogynecologist Federal University, San Paolo. Brazil. Chantale Dumoulin, Physiotherapist University of Montreal. Montreal, Quebec. Canada. Mario Gomes, Urologist Centro Hospitalar Porto. Oporto. Portugal. Doreen McClurg, Physiotherapist/Reader Glasgow Caledonian University. Glasgow. United Kingdom. Jane Meijlink, Patient Advocate Rotterdam. Netherlands. Elizabeth Shelly, Physiotherapist Moline, Illinois. USA 3 Emanuel Trabuco, Urogynecologist Mayo Clinic. Minnesota. USA. Carolina Walker, Physiotherapist FUB Manresa, Autonomous University of Barcelona. Barcelona. Spain. Amanda Wells, Continence Nurse University of Exeter, Exeter, United Kingdom Correspondence to: Professor Kari Bo, Norwegian School of Sport Sciences, Department of Sports Medicine Ph: +4723262000; Fax: +4723234220 PO Box 4014, Ullevål Stadion, 0806 Oslo, Norway e-mail: [email protected] 4 ABSTRACT Introduction: There has been an increasing need for the terminology for the conservative management of female pelvic floor dysfunction to be collated in a clinically-based consensus report. Methods: This Report combines the input of members and elected nominees of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted at intervals by many external referees. An extensive process of six rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). Before opening up for comments on the webpages of ICS and IUGA, five experts from physiotherapy, neurology, urology, urogynecology and nursing were invited to comment on the paper. Results: A Terminology Report for the conservative management of female pelvic floor dysfunction, encompassing over XXX separate definitions, has been developed. It is clinicallybased with the most common symptoms, signs, assessments, diagnoses and treatments defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Ongoing review is not only anticipated but will be required to keep the document updated and as widely acceptable as possible. Conclusion: A consensus-based Terminology Report for the conservative management of female pelvic floor dysfunction has been produced aimed at being a significant aid to clinical practice and a stimulus for research. 5 WORDS (Introduction-Section 5) XXXX FIGURES XX KEYWORDS Consensus, Conservative Management, Pelvic Floor Dysfunction, Terminology, Female Acknowledgement: the 5 external experts DISCLOSURES: 6 INTRODUCTION There is currently no single document addressing the conservative management of female pelvic floor dysfunction in a comprehensive way. The report is based on, and follows on from, the terminology proposed by the International Continence Society (ICS) Standardization of Terminology of Lower Urinary Tract Function [Abrams et al 2002, [1], The Standardization of Terminology of Pelvic Floor Muscle Function and Dysfunction: Report from the pelvic floor clinical assessment group of the International Continence Society [Messelink et al 2005 [2] and the International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction [Haylen et al 2010 [3]. The terminology in current use related to conservative management generally lacks uniformity, which can lead to uncertainty, confusion and unintended ambiguity. It hampers our the ability to build a body of literature concerning conservative interventions, e.g. the terms “behavioral therapy”, “lifestyle intervention”, “conservative treatment”, “non-surgical treatment”, “physiotherapy”, “biofeedback”, and “pelvic floor muscle exercise” are often used interchangeably and, at times, incorrectly to describe both the same and different interventions. Several practitioners involved in this area commonly use discipline-specific parlance. It is important to recognise that several practitioners have a role in this field. A more standardised terminology would aid inter-specialty communication and understanding. Existing published reports address some of the aspects of this topic, but there are some areas currently lacking in standardisation of terminology, e.g. Messelink et al [2] and Haylen et al [3] refer to evaluation and diagnostic terminology, but not treatment terminology. 7 There is a need for a more extensive description of management of pelvic floor and pelvic floor muscle dysfunction than is currently provided in existing terminology reports. With the development of the evidence-base for conservative therapies in the management of pelvic floor dysfunction, especially treatment of conditions such as incontinence and pelvic organ prolapse, terminology linked with these managements has evolved but with regional and discipline variations. A consensus on currently accepted terminology is required. Elements in the title of the document need to be defined: Conservative: is restricted to non-surgical and non-pharmacological management. Management: will include the following aspects: a) Assessment: including history and physical examination and investigations; b) diagnosis, c) prevention and d) treatment of pelvic floor dysfunction. Pelvic floor: structures located within the bony pelvis: urogenital and anorectal viscera, pelvic floor muscles and their connective tissues, and nerves and blood vessels. Pelvic floor dysfunction: Following on from Messelink et al 2005 report from the pelvic floor clinical assessment group of the ICS [2], this report will focus on terminology of management of pelvic floor function and dysfunction including bladder and bowel dysfunction, POP, sexual dysfunction and pelvic pain (Bump and Norton 1998 [4]). Terminology regarding pelvic pain and anorectal dysfunction related to pelvic floor muscle dysfunction (PFD) will align with the current working group on 8 chronic pelvic pain. Terminology will include symptoms (expanding on the Messelink et al [2] ; signs and investigations (Messelink et al [2]; diagnoses of pelvic floor muscle-related conditions (avoiding duplication with Haylen et al [3]; prevention and treatment (including new therapies, e.g. exercise and adjunctive therapies including equipment, and lifestyle modifications – not covered by Messelink et al [2] or Haylen et al [3]. Additional definitions related to the content of this manuscript Practitioners/ Clinicians Conservative management of PFD may be provided by different practitioners, commonly physiotherapists / physical therapists, nurses, midwifes and medical doctors. However, other professions e.g. fitness instructors and personal trainers may also have a role in both education, health promotion and prevention of PFD. Terminology related to the accepted names of professions and the different types of therapy must be specified and distinguished (e.g. ‘physiotherapy’ as a management provided by a registered physiotherapist, distinct from ‘conservative therapy’ and ‘exercises’ / ‘biofeedback’ which may be provided by any speciality. The emphasis in this document will be on management commonly undertaken by diciplines practising conservative management. “Multi-disciplinary approach” Relating to, or involving, two or more disciplines that are usually considered distinct (Bottomley 2013). E.g. physical therapy, urology, gynecology Gender. With the increasing specificity and complexity of female diagnosis and management it can be argued that a gender specific report is needed. However many of the terms defined in this 9 report are not gender specific and will be the same for males e.g. pelvic floor muscle training and electrical stimulation. This report does not exclude an additional future report on male pelvic floor dysfunction. METHODOLOGY All working group members were asked to provide terms that they knew existed in the area. After the first “brainstorming activity”, all terms were listed and grouped according to introduction, symptoms, signs, examination methods, investigations, diagnosis, prevention and treatment. All members were given the text to add more terms. Additional searching for omitted terms in existing terminology papers of the ICS and IUGA, Cochrane reviews and the 2013 ICI document [Abrams et al 2013] were undertaken. Existing definitions of established terms from general medicine (Merriam-Webster, Oxford Dictionary), physiotherapy [Bottomley 2013] and exercise science were used where available. Only in situations where there was no existing terminology, were new definitions introduced. We have not referred to or described the responsiveness, reliability and validity of the measurement methods of symptoms, signs and evaluations, nor the evidence for treatment efficacy of any of the therapies defined. Consensus on the definitions was reached by simple voting. Wherever possible, evidence based principles were followed. However, this was anticipated to be a challenge in conservative management as there are many suggested therapies that have not proved to be effective [Bø and Herbert 2009, Bø and Herbert 2013]. Discussion meetings with representatives of IUGA and ICS were held at the following annual meetings: IUGA Brisbane 2012, ICS Beijing 2012, IUGA Dublin 2013, ICS Barcelona 2013, IUGA-AUGS Washington DC 2014. 10 It is suggested that acknowledgment of these standards in written publications related to conservative management of female pelvic floor dysfunction is read as follows: “Methods, definitions and units conform to the standards jointly recommended by the IUGA-ICS joint report on the terminology for the conservative management of female pelvic floor dysfunction, except where specifically noted”. SECTION 1: ASSESSMENT 1.1. SYMPTOMS Symptom: Any morbid phenomenon or departure from the normal in structure, function or sensation, experienced by the woman and indicative of disease or a health problem. Symptoms are either volunteered by, or elicited from the individual, or may be described by the individual’s caregiver [3] 1.1.A: Existing (defined) Symptoms [3] (i) Urinary incontinence symptoms [3] (ii) Bladder storage symptoms [3] (iii) Sensory symptoms [3] (iv) Voiding and postmicturition symptoms [3] (v): Pelvic organ prolapse (POP) symptoms [3] (vi) Symptoms of sexual dysfunction [3] (vii) Symptoms of anorectal dysfunction [3] Footnote; Sultan et al []Treminology for female Anorectal Dysfunction (viii) Lower Urinary Tract Infection [3] 11 1.1.B: Lower Urinary Tract Pain and/or Other Pelvic Pain Footnote: Comprehensive definition of these terms is covered by Doggweiler et al [2015] (i) Pain (in general): An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.” [IASP Taxonomy of Pain Terms Part_III-PainTerms 2012]. (ii) Acute pain: pain related to acute trauma, infection or other well-defined disease processes or conditions. (iii) Chronic pain: Persistent or continuous / recurrent pain for at least 6 months. If non-acute and central sensitization pain mechanisms are well documented, then the pain may be regarded as chronic, irrespective of the time period [Baranowski et al 2012, Engeler et al 2012] (iv) Chronic pelvic pain syndrome (CPPS): persistent pain perceived in structures related to the pelvis, in the absence of proven infection or other obvious local pathology that may account for the pain. (v) Chronic pelvic floor muscle pain syndrome: the occurrence of persistent or recurrent, episodic, pain in any of the pelvic floor muscles. Muscle pain is termed myalgia. 12 Footnote: Symptoms of pelvic floor myalgia should be described in terms of location, quality, intensity, pattern, duration frequency, moderating factors and associated symptoms. Pain details may include: a. whether pain is present at rest or mechanical in nature (related to muscle contraction or relaxation or body posture) and / or altered with change of posture (lying to sitting, sitting to standing) or movement (bending, walking, sexual activity) b. may be uni- or bilateral in nature c. may be accompanied by bladder or bowel dysfunction, vulvodynia or dyspareunia (superficial/deep). Pelvic floor myalgia (a symptom) may be present with or without an increase in PFM tone (a sign). 1.2: SIGNS Sign: Any abnormality indicative of disease or a health problem, discoverable on examination of the patient; an objective indication of disease or a health problem [1]. 1.2 A: Existing (defined) signs [3] (i) Urinary incontinence signs: [3] a.Urinary incontinence [3] b.Stress (urinary) incontinence [3] c.Urgency (urinary) incontinence [3] d.Mixed (urinary) incontinence e.Extraurethral incontinence [3] f.Stress incontinence on prolapse reduction (occult or latent stress incontinence) [3] 13 (ii) Pelvic organ prolapse [3] a.Uterine/cervical prolapse [3] b.Vaginal vault (cuff scar) prolapse [3] c.Anterior vaginal wall prolapse [3] d.Posterior vaginal wall prolapse [3] (iii) Other pelvic examinations/signs [3]: a.Vulval abnormalities [3] b.Urethral mucosal prolapse [3] c.Urethral caruncle [3] d.Urethral diverticulum [3] e.Total vaginal length (TVL): the distance from hymen to the posterior fornix [Bump et al1996] - vaginal elevation: inward (ventro-cephalad) movement of the vagina e.g during PFM contraction - Vaginal descent: outward (dorso-caudal) movement of the vagina e.g. during cough or valsalva f. Valsalva maneuver: the action of attempting to exhale with the nostrils and mouth, or glottis closed [Oxford dictionary]. Is usually performed with digital closure of the nose as in trying to equalize pressure in a plane. Straining / bearing down may have a similar meaning, however in practice it may be interpreted to mean pushing downwards and trying to relax the pelvic floor, as in defecating g.Bimanual pelvic examination [3] 14 h. Perineal elevation: inward (ventro-cephalad) movement of the vulva, perineum, and anus during e.g. PFM contraction, i.Perineal descent: excessive dorso-caudal movement of the vulva, perineum, and anus e.g during cough, Valsalva or straining [Henry et al 1982; Haylen 2010]. j.Trophic: promoting cellular growth, differentiation and survival [Merriam-Webster.com]. This is the normal status of an organ, tissue or cell in regards to nutrition, size, number, form and function. A trophic urogenital tract is usually well-estrogenized k.Atrophic: Decrease from previous normal size of the body or a part, cell, organ, or tissue. An organ or body part's cells may be reduced in number, size or both. Atrophy of some cells and organs is normal at certain points in the life cycle. Other causes include malnutrition, disease, disuse, injury, and hormone over- or underproduction [Merriam-Webster.com]. Footnote: Atrophy of urogenital tract is normal at certain points in the life cycle, mainly caused by aging and hypoestrogenism. (adapted from http://www.merriam-webster.com/dictionary . [Leiblum, 1981] (iv) Anal signs [Sultan et al 2014] (v) Abdominal signs 15 a. Bladder fullness/retention: Abdominal palpation or suprapubic percussion may indicate a full bladder, however in overweight patients this may not be easily detected. b. Pelvic bone irregularities: indication of previous fracture or sacral agenesis (vi) Neurological signs Neurological conditions may be associated with pelvic floor dysfunction. Signs of possible neurogenic etiology (altered sensation, muscle tone or reflexes) should be referred for more specific neurological examination. 1.2.B: Pelvic Floor Muscle Function Signs (NEW) (i) Normal pelvic floor muscles: have a level of constant resting tone (except just before and during voiding and defecation), symmetry and ability to voluntarily and involuntarily contract and relax. (ii) Normal pelvic floor muscle contractile function: A constriction and inward (ventrocephalad) movement of the pelvic openings. Normal, well-functioning pelvic floor muscles may demonstrate some (controlled or limited) downward dorsal perineal movement in response to increased intra-abdominal pressure in the absence of incontinence or pelvic organ prolapse [New] (iii) Muscle tone: In normally innervated skeletal muscle, tone is created by ‘active’ (contractile) and ‘passive’ (viscoelastic) components. Footnote: Muscle tone is evaluated clinically as the resistance provided by a muscle when a pressure / deformation or a stretch is applied to it (Simons and Mense 1998, Mense et al 2001, 16 Enoka 2008). Muscle tone may be altered in the presence or absence of pain. There is no single accepted or standardised way to measure muscle tone, and there are no normative values. a.Hypertonicity: a general increase in muscle tone that can be associated with either elevated contractile activity and / or passive stiffness in the muscle [Simons and Mense 1998, Masi 2008]. As the cause is often unknown the terms neurogenic hypertoncity and non-neurogenic hypertonicity are recommended. b.Hypotonicity: a general decrease in muscle tone that can be associated with either reduced contractile activity and / or passive stiffness in the muscle. As the cause is often unknown the terms neurogenic hypotonicity and non-neurogenic hyportonicity are recommended. (iv) Stiffness: resistance to deformation [Nordin & Frankel 2012]. Passive elastic stiffness is defined as the ratio of the change in the passive resistance or passive force (ΔF) to the change in the length displacement (ΔL) or ΔF/ ΔL (Gajdosik 2001). The term should only be used if stiffness is measured. (v) Muscle compliance: Passive compliance is defined as the reciprocal of muscle stiffness [Gajdosik et al 2001, Nordin & Frankel 2012]. (vi) Tension: may have a similar meaning to tone and stiffness Muscle tension can be increased or decreased due to exogenous factors such as the amount of pressure applied and endogenous factors such as thickness/ cross sectional area of the muscle itself, fluid present within the muscle (swelling, inflammation), position (e.g. standing versus sitting) or increased neural activity. 17 (vii) Spasm: persistent contraction of striated muscle that cannot be released voluntarily. If the contraction is painful, this is usually described as a cramp. Occurs at irregular intervals with variable frequency and extent [Mumenthaler 1992]. Spasm over days or weeks may lead to a contracture. (viii) Contracture: an involuntary tightening of a muscle. Clinically, a muscle cramp and contracture may appear similar, however contractures are electrically silent [Preston & Shapiro 1998 p528]. (ix) Cramp: a painful involuntary muscle contraction that occurs suddenly and can be temporarily debilitating. Pain is intense and localised. It tends to occur when the muscle is in the shortened position and contracting, is generated by motor units, and displays a high firing rate (20 – 150 Hz) [Preston & Shapiro 1998, p181]. Muscle cramp either during or immediately after exercise is commonly referred to as “exercise associated muscle cramping” [Brukner & Kahn 2012 4th ed, p22], however cramps are not specific to exercise. (x) Fasciculation: a single, spontaneous, involuntary discharge of an individual motor unit. The source generator is the motor unit or its axon, prior to its terminal branches. Fasciculations display an irregular firing pattern of low frequency (0.1 – 10 Hz) [Preston & Shapiro 1998, p187, Bottomley]. Clinically, fasciculations are recognised as individual brief twitches. They may occur at rest or after muscle contraction and may last several minutes. 18 (xi) Trigger point (TrP): a tender, taut band of muscle that can be painful spontaneously or when stimulated [Gerwin 2010]. The taut band is electrically silent. Footnote: Local or referred pain may be reproduced. An active TrP is said to have a characteristic “twitch” response when stimulated, however the twitch response to palpation has been shown to be unreliable [Lucas et al 2009]. The most reliable sign of a TrP is sensitivity to applied pressure. (xii) Pelvic floor muscle dyssynergia [2]: A situation in which the pelvic floor muscles do not relax, or may even contract paradoxically when relaxation is functionally needed for example during micturition, or defaecation (anismus) or during sexual activity (vaginismus). (xiii) Non-functioning pelvic floor muscles [2]: A situation in which there is no pelvic floor muscle action measurable either on instruction to contract (inability) or as the absence of an automatic response to an increase in intra-abdominal pressure. This condition can be based on any pelvic floor symptom and on the sign of a non-contracting or non-relaxing pelvic floor (xiv) Pelvic floor muscle injury (PFMI): On clinical palpation, PFMI is diagnosed when one or more of the following is present: 1. A discontinuity of the puborectalis muscle at its attachment to the inferior pubic ramus; 2. A distance of > 3.5 finger widths between the two sides of puborectalis muscle insertion (1); 3. A gap in the continuity of the pubovisceral muscle between the pubic rami and the anorectum [2?]. (xv)Muscle action characteristics 19 a.Maximal voluntary contraction (MVC): The attempt to recruit as many fibres in a muscle as possible for the purpose of developing force [Knuttgen & Kraemer, 1987,s. 3] b.Muscle strength: Force-generating capacity of a muscle [Buttomly 2013]. It is generally expressed as maximal voluntary contraction measurements and as the one- repetition maximum (1RM) for dynamic measurements [Howley, 2001, Knytgen, Komi] c.Local muscle endurance: The ability to sustain near maximal or maximal force, assessed by the time one is able to maintain a maximum of static or isometric contraction, or ability to repeatedly develop near maximal or maximal force determined by assessing the maximum number of repetitions one can perform at a given percentage of 1 RM [Wilmore and Costill 1999] d.Muscle power: The explosive aspect of strength; the product of strength and speed of movement (force x distance/time) [Wilmore and Costill 1999] e.Co-ordination: Property of movement characterized by the smooth and harmonious action of groups of muscles working together to produce a desired motion [Bottomley, 2013, p. 42] f.Motor control: The ability of the nervous system to control or direct the muscles in purposeful movement and postural adjustment by selective allocation of muscle tension across appropriate joint segments [Vudocek, Bottomley] 20 g.Submaximal contraction: all contractions without maximal effort, expressed as a percentage of 1 RM [ref?]. h.Synergistic contraction: the combination of several muscle actions that serve to optimally achieve a motor task [Knudson, 2007]. i. Co-contraction: Contraction of more muscles at the same time. Co-contraction of muscles can be synergistic (e.g. resulting in an augmentation of motor activity) or it could be counterproductive to normal function (e.g contraction of antagonistic muscles resulting in abnormal movement or training other muscles instead of the targeting ones; e.g. training of gluteal muscles instead of the PFM). j. Antagonistic contraction: contraction of muscle/muscle groups with opposite action as the wanted action (activity that hinders the targeted muscle/muscle group from contracting). Important for coordination and slowing down a movement and for stability of joints (xvi) Other a.Hypertrophy: the increase in size (volume) of the muscle fibers [Knudson 2007] b. Atrophy: the decrease in size of muscle fibers. Atrophy can occur in response to inactivity, illness or aging. [Lauralee Sherwood, Human Physiology: From Cells to Systems, p.251] c.Bulk: The absolute volume of a muscle measured by imaging techniques such as anatomical MRI and US [Kent, 1998, s.333] 21 d.Anatomic cross sectional area: for an individual muscle, the largest cross-sectional area along the length of that muscle and 90° on the muscle length [Oxford] e.Physiological cross sectional area: the total area of cross-section perpendicular to the muscle fibers [Oxford] f. Flexibility: the ability of a muscle to lengthen and allow one joint (or more than one joint in a series) to move through a range of motion. Loss of flexibility is defined as a decrease in the ability of a muscle to deform [ ref Alter]. g.Proprioception: Sensory information from receptors of muscles, joints, capsules and ligaments that provides information of posture and movements [Aage R.MØller Intraoperative neurophysiological monitoring, third edition, 2011, p.57-58] . h.Exteroception: sensory information from receptors in the skin registering touch, vibration, heat, and cold. [Aage R.MØller Intraoperative neurophysiological monitoring, third edition, 2011, p.57-58] SECTION 2: INVESTIGATIONS AND IMAGING 22 All devices used for assessments (eg manometers, dynamometers, EMG, urodynamics, ultrasound and MRI) must be described in detail, and their responsiveness (ability to detect small changes), reliability and validity should be reported [Bø & Sherburn 2005]. 2.1: Existing (defined) investigations [3]: 2.1.A.Urodynamics [3]: Functional study of the lower urinary tract (i)Uroflowmetry [3]: (ii) Post-void residual (PVR –urine volume) [3] (iii) Cystometry [3]: (iv) Pressure flow study [3]: (v) Assessment of Urethral Function[3] a. Urethral pressure measurement [3] b. Abdominal leak point pressure (ALPP) [3] 2.1.B.Frequency-volume chart (FVC)/ bladder diary: the recording of the time of each micturition and the volume voided for at least 24 h, although two or three days of recording (not necessarily consecutive) will generally provide more useful clinical data [Haylen]. (i). Bladder diary: In addition to the FVC, a bladder diary will include fluid intake, pad usage, incontinence episodes, provocation and severity of leakage and episodes of urgency [Haylen] 2.1.C. Pad testing: quantification of the amount of urine lost in a fixed period of time, by measuring the increase in weight of a perineal pad[Haylen]. 23 2.1.D. Ultrasound imaging [3]: (i) Pelvic floor muscle injury (PFMI): PFMI is diagnosed on ultrasound when at least one of the following is present: 1. Undetected puborectalis-to-ipsilateral sidewall attachment on any of the three central slices (full avulsion); 2. Undetected puborectalis-to-ipsilateral sidewal attachment on at least one slice (partial avulsion) (3); 3. A levator-urethra gap (LUG) of greater than 2.5cm (4). (ii) PFM position in the pelvis can be measured in the sagittal plane and can be related to PFM dysfunction (elevated or descended pelvic floor). 2.1.E. Radiological imaging [3]: Videocystourethrography (VCU); intravenous urography (VCU); micturating cystography (MCU); defecography; colporecto-cystourethrography; 2.1.F. Magnetic resonance imaging (MRI) [3]: (i) Pelvic floor muscle injury is diagnosed on MRI when one or more of the following is present: 1. Hypersignal, thinning or thickening of the puborectalis muscle, or rupture of its insertion into the bone (5, 6); 2. Absence of puborectalis muscle fibers are in at least one 4-mm section or two or more adjacent 2-mm sections in both the axial and coronal planes [7]). NEW (ii) PFM position in the pelvis can be measured and can be related to PFM dysfunction (elevated or descended pelvic floor). 2.2. Manometer: a device to measure pressure 24 2.2.A. Pelvic floor manometry: measurement of resting pressure or pressure rise generated during contraction of the PFM using a manometer connected to a sensor which is inserted in the urethra, vagina or rectum. Pelvic floor manometric tools measure pressure in either mmHg, hPa or cmH2O [Bo and Sherburn, 2005]. Footnote: the pressure measured does not confirm its origin, and pressure measurement is only valid when used in combination with other methods e.g. simultaneous observation of inward movement of the perineum or device. (i) Perineometer: the first PFM vaginal pressure device connected to a manometer, which was developed by Kegel [Kegel 1948]. Footnote: The term perineometer is somewhat misleading as the pressure-sensitive region of the manometer probe is not placed at the perineum but inside the vagina at the level of the levator ani. Vaginal pressure devices should be referred to as PFM manometers [Bo and Sherburn, 2005; Kegel, 1948]. 2.3: Dynamometer: any of number of instruments for measuring power or force [World English Dictionary] 2.3.A. Pelvic floor dynamometry: measurement of PFM resting and contractile forces using strain gauges mounted on a speculum (a dynamometer), which is inserted into the vagina [Dumoulin, et al., 2003]. Dynamometry measures force in Newton units (N). 25 Footnote: todays dynamometers for the pelvic floor also measures use of muscles other than the pelvic floor. Opening of the speculum may cause pain or discomfort that may influence measurements. PFM dynamometers are not commercially available. 2.4. Electromyography (EMG): the recording of electrical potentials generated by the depolarization of muscle fibers. 2.4.A. Electromyographic Diagnosis: state of the muscle (muscle pathology) by recording and analysing the electrical activity generated by the muscle. EMG in this case usually means “concentric needle EMG”, but other eEMG methods exist. Electromyography is typically distinguished as intra-muscular or surface. Electromyographic diagnosis is often used as a synonym for “neurophysiological diagnosis of the peripheral neuromuscular system”, and that would include also measurement of motor and sensory conduction, recording of reflex responses etc [Vudosek, Bo’s book]. EMG measurements are not a direct measure of muscle strength. Researchers are encouraged to specify the type of electrode being used. (i) Intra-muscular EMG: insertion of a wire or needle electrode into the muscle to record motor unit action potentials. This is not typically used in clinical assessment, but may be included in research or advanced examinations for example to diagnose striated muscle denervation/reinnervation [Vudosek, chapter, Bo’s book] (ii) Surface Electromyography: Electrodes placed on the skin of the perineum or inside the urethra, vaginal or rectum. Surface EMG is considered to be not as-specific as intra-muscular EMG. The large surface area of the electrodes may result in cross-talk from adjacent muscles, 26 and other artifact therefore technical expertise is required. EMG can reveal the pattern of activity of a particular muscle as in the diagnosis of detrusor sphincter dyssynergia during urodynamics [Messelink, 2005; Vodusek, 2007]. 2.5: Pain assessment 2.5.A. Pain evaluation: . Pain evaluation includes: Baseline and ongoing regular evaluation of severity, quality of life, questions about thoughts, emotions and behavior associated with the pain (questionnaires) and investigations to identify well-defined/confusable/non-pain syndromes. (i) Pain measurement Pain can only be measured subjectively. a. Numerical rating scale (NRS), from 0 (no pain) to 10 (extreme pain), with half-points marked [Dworkin et al 2008, Hawker et al 2011]. b. Visual analogue scale (VAS), a 10-cm line with the same labels at the ends c. A simple verbal rating scale can be used, e.g. ‘none’, ‘mild’, ‘moderate’, ‘severe’. Footnote: Because pain is multidimensional, a single rating scale combines these dimensions in unknown quantities. One may separately assess pain intensity, pain distress, and interference of pain with activities of daily life. (ii) Pain mapping: identifying pain generators through diagnostic procedures such as questionnaires, EMG, quantitative sensory threshold measurement, trigger point injections, nerve blocks and imaging. 27 a. Questionnaires: in addition to the patient reported outcomes to measure pain as described above, there are several general pain questionnaires that can be used in evaluation of musculoskeletal pain in the pelvis e.g: McGill Pain Questionnaire [Droz et al 2011], PFDI [Barber et al 2011], FSFI [Gerstenberger et al 2010], FSDS [Derogatis 2002], Pelvic Pain and Urgency/Frequency Questionnaire (PUF) [Ouaghebeur & Oyndaele 2013] b. Pain chart / body map: a simple line drawing of an outline of the front and back (or relevant body part) of the human body, onto which the patient sketches or ticks or marks areas of bodily pain to demonstrate the site and extent of perceived pain [ http://www.pcs.org.uk/en/resources/health_and_safety/health_and_safety_reps_toolkit/bodymapping.cfm). ] c.Pain checklist: a list of anatomical locations from which the patient selects relevant sites to his/her complaint. d.Measurement of Muscle tone There is no single tool which is able to measure all components of muscle tone. Some tools may be able to measure aspects of tone such as contractility, stiffness or elasticity. Instrumented methods may have a role in the valid and reliable evaluation of muscle tone/stiffness e.g. Surface electromyography (sEMG), wire and concentric electromyography, dynamometry, real-time ultrasound, elastometry [Kruger et al 2011], myotonometry. e.Trigger point injection or needling: a diagnostic test to identify pain generators. The technique is the same as used in TrP treatment. f.Imaging: Tissue-specific evaluation of pain to identify morphological trauma or deficit can include X-Ray, ultrasound and MRI 28 SECTION 3: Existing (defined and most common) diagnoses: Diagnosis: the act or process of identifying or determining the nature and cause of a disease or injury through evaluation of patient history, examination and review of laboratory data and the opinion derived from such an evaluation [Haylen?] [free dictionary?] A diagnosis for female PFD is based on the information obtained from the patient’s symptoms, signs, and any relevant diagnostic investigations. For the terminology of the 6 most common PFD diagnoses; urodynamic stress urinary incontinence (USI), detrusor overactivity (DO), POP, voiding dysfunction, bladder oversensitivity and recurrent UTI, the reader is directed to Haylen et al [2010]. 3.1. Differential diagnosis: The determination of two or more diseases with similar symptoms is the one from which the patient is suffering, by systematic comparison and contrasting of the clinical finding [Stedman's Medical dictionary]. 3.2 Urinary tract 3.2.A Urodynamic stress incontinence [3] 3.2.B. Detrusor overactivity [3]: 3.3. Pelvic organ prolapse [3]: The descent of one or more of the anterior vaginal wall, posterior vaginal wall, the uterus (cervix) or the apex of the vagina (vaginal vault or cuff scar after hysterectomy). 29 Footnote: The presence of any such sign should be correlated with relevant POP symptoms. Most commonly, this correlation would occur at the level of the hymen or beyond 3.4. Bowel Diagnosis 3.4.A. Local (fissures, hemorrhoids) [Sultan et al 2014] 3.4.B. Fecal incontinence [Sultan et al 2014] 3.4.C. Obstructed defecation syndrome [Sultan et al 2014] 3.4.D. Rectocele [Sultan et al 2014] 3.4. E. Enteroscle/sigmoidocele [Sultan et al 2014] 3.4.F. Intussusception [Sultan et al 2014] 3.4.G. Internal muscosal prolapse [Sultan et al 2014] 3.4.H. Absee\ss/fistula [Sultan et al 2014] 3.4.I. Pain syndromes [Sultan et al 2014] 3.4. J.Pouch of Douglas hernia / Descending perineum syndrome: a pelvic floor disorder found in patients with pronounced constipation or with fecal incontinence. Typical symptoms include excessive and frequent straining to pass bowel movements and feeling of incomplete emptying. Physical exam reveals pronounced perineal descent with or without pelvic organ prolapse or rectal prolapse. Hallmark radiologic finding is perineal descent greater than 4 cm on defecography or dynamic MRI. Patients have an abnormally deep Pouch of Douglas that may be acquired due to excessive straining or may be congenital [Baessler K, Schuessler 2006]. Footnote: Other urological, gynaecological, gastro-intestinal and colo-rectal pain conditions without related pelvic floor dysfunction, are well described in standard texts. Many pelvic floor pain-related conditions or syndromes (e.g. vulvodynia, interstitial cystitis/bladder pain syndrome, 30 pelvic congestion syndrome, irritable bowel syndrome) are described in Standard for Terminology in Chronic Pelvic Pain Syndromes (CPPS): A Report from the Ad Hoc Working Group of the International Continence Society Standardization Steering Committee (ICS-SSC) on Chronic Pelvic Pain ICS Standardization of Terminology document on Chronic Pelvic Pain (Doggweiler et al 201x). Several other systemic disorders (e.g. chronic fatigue syndrome, diabetes) may impact on the pelvic floor, however pelvic floor dysfunction is not part of their recognized etiology. 3.5. Female sexual dysfunction: any departure from normal sensation and/or function expressed by a woman during sexual activity [Haylen et al 2010] (i) Dyspareunia [Haylen 2010] (ii) Obstructed intercourse [Haylen 2010] (iii) Vaginal laxity [Haylen 2010] (iv) Other complaints [Haylen 2010] SECTION 4 – TREATMENTS NEW 4.1. GENERAL TERMS 4.1.A. Behavioral: the way someone behaves, especially towards other people», and behavioral science is the study of human behavior [Oxford Advanced American Dictionary]. 31 (i) Behavior therapy: The treatment of neurotic symptoms by training the patient’s reactions to stimuli [Oxford Dictonary]. We recommend that “behavioral” be limited to studies that evaluate how people do or do not behave as desired. 4.1.B. Physiotherapy: Physiotherapy involves “using knowledge and skills unique to physiotherapists” and, “is the service only provided by, or under the direction and supervision of a physiotherapist” [WCPT 1999]. We recommend that the specific treatment is described e.g. pelvic floor muscle training, electrical stimulation rather than the unspecific term physiotherapy. The latter also referring to a specific profession. Footnote: Publications should report the actual professional who provided the intervention (e.g., physiotherapist, general practitioner, urogynecologist, urologist, midwife, nurse, fitness instructor), rather than using the vague term, “therapist” / “clinician” / “researcher”. 4.1.C. Adherence: the extent to which a client/patient’s behaviour corresponds to the agreed treatment protocol and/or regime as recommended by their healthcare provider [WHO, 2003]. Footnote: Adherence is usually reported as the number or percentage of (1) clinical visits attended and (2) home exercises or regimen components followed or completed by the client/patient. 4.1.D. Compliance: the extent to which a client/patient’s behaviour matches, or complies with, their healthcare provider’s recommended treatment protocol and/or regime [WHO, 2003]. 32 Footnote: The term ‘adherence’ is generally preferred within healthcare as it acknowledges client/patient autonomy and implies a willingness on their part to participate and cooperate rather than the traditional view, inherent in ‘compliance’, of an expert clinician dictating to a naive patient [NICE, 2009; WHO, 2003]. 4.1.E. Combination therapy: also known as polytherapy, multimodal therapy or combined modality therapy. Combination therapy is the use of more than one therapy concurrently for a single condition with one or multiple symptoms, for example a combination of medication with pelvic floor muscle training. [http://en.wikipedia.org/wiki/Combination_therapy oxford}? (i). Adjunctive therapies: Any treatment or modality used to augment or assist the main treatment. In conservative treatments, adjunctive therapies often refer to equipment or a secondary therapy used to supplement the effect of the primary therapy, e.g. biofeedback-assisted PFMT; NMES to augment PFMT 33 4.1.F. Prevention: The act of preventing; decreasing the risk of disease or disability. Activities that are directed toward slowing or stopping the occurrence of both mental and physical illness and disease, minimizing the effects of a disease or impairment on disability, or reducing the severity or duration of an illness [WHO]. (i)Primary prevention: prevention of the development of disease in a susceptible or potentially susceptible population through such specific measures as general health promotion efforts (ii)Secondary prevention: efforts to decrease the duration of illness, reduce severity of diseases, and limit sequelae through early diagnosis and prompt intervention (iii)Tertiary prevention: efforts to limit the degree of disability and promote rehabilitation and restoration of function in patients/clients with chronic and irreversible diseases [WHO](Bottomley, 2013, p. 150) 4.2. LIFESTYLE 4.2.A. Lifestyle modification: the application of interventions in management of lifestylerelated health problems e.g change to healthy diet and regular participation in physical activity and stop smoking [ref] . The following lifestyle modifications may be applied to treat pelvic floor dysfunction, either in combination with other therapies or as ‘stand-alone’ treatments. (i)Fluid consumption/restriction: Fluid consumption is the intake of fluid over 24 hours. Fluid restriction is the limitation of fluid to a prescribed amount over a period of 24 hours [ref] 34 (ii) Dietary modification: An alteration or adjustment of food to treat bowel disorders (e.g. constipation and faecal incontinence) or urinary disorders (e.g. incontinence or urgency), e.g. increase of fibre to treat constipation [].Specifics of the dietary changes should be described. (iii) Elimination diet: A form of dietary modification. A diet designed to detect what ingredient of the food causes allergic symptoms in the patient, foods items of which the patient may be sensitive are withdrawn separately and successfully from the diet until the item that causes the symptoms is discovered. Used frequently in patients with faecal incontinence and urgency and urge incontinence (bladder diet) [Friedlander et al 2012, Shorter et al 2007] (iv) Physical activity: Any body movement produced by the skeletal muscles that result in a substantial increase over the resting energy expenditure. Physical activity can be done at work, as transportation, as household and other chore activity and leisure- time/ sport and fitness activities [Bouchard et al., 1993]. Footnote: Increase of physical activity level may work on UI via weight reduction in obese persons. Several studies have shown that there is a high prevalence of UI in physically active women during exercise (especially during high impact activity, defined as running and jumping) 4.2.B. Counseling: the provision of professional assistance and guidance in resolving personal or psychological problems [Oxford] 35 (i)Patient education: providing patients with knowledge and understanding of their condition thereby empowering them to play an active role in its management [Meijlink 2013] : (ii)Motivational interviewing: a directive, client-centered counselling style for eliciting behaviour change by helping clients to explore and resolve ambivalence. Compared with nondirective counselling, it is more focused and goal-directed. The examination and resolution of ambivalence is its central purpose, and the counsellor is intentionally directive in pursuing this goal [Rollnick & Miller, 1995]. (iii) Coping strategies aimed at helping patients to live with the condition as best as possible under the circumstances, to regain a feeling of being in control, to adjust their lifestyle where necessary and to take a positive rather than negative approach [Meijlink 2013] (iv) Cognitive behavioral therapy: a type of psychotherapy in which negative patterns of thought about the self and the world are challenged in order to alter unwanted behaviour patterns or treat mood disorders [Oxford]. a.Self care: the set of activities that comprise daily living, such as bed mobility, transfers, ambulation, dressing, grooming, bathing, eating, and toileting [Bottomley, 2013]. b.Self help: various methods by which individuals attempt to remedy their difficulties without making use of formal care providers [Bottomley, 2013] 36 c.Self-efficacy:: an individual’s belief that he or she is capable of successfully performing a certain set of behaviors [ Bandura,Bottomley, 2013] 4.3. SCHEDULED VOIDING REGIMES: Toileting on a fixed schedule around the patient’s normal voiding pattern which includes a progressive voiding schedule using relaxation and distraction techniques for urgency suppression [Wyman 2009?] Scheduled voiding regimes has been categorised as: bladder training, timed voiding, habit training and prompted voiding [Moore et al 2013]. 4.3.A.Bladder training (also referred in the past to as bladder drill, bladder discipline, bladder re-education, bladder re-training): a program of patient education along with a scheduled voiding regimen with gradually progressive voiding intervals. Specific goals are to correct faulty habit patterns of frequent urination, improve control over bladder urgency, prolong voiding intervals, increase bladder capacity, reduce incontinent episodes and restore patient confidence in controlling bladder function [Moore et al 2013]. Footnote: Ideally the voiding intervals should be increased by 15-30 minutes each week, according to the patients tolerance to the schedule, until a voiding interval of 3-4 hours is achieved. Use of a bladder diary is recommended for self-monitoring of progress [Wyman et al, 200]) 4.3.B. Timed voiding: a fixed voiding schedule that remains unchanged over the course of treatment [Moore et al 2013] 37 4.3.C. Habit training: a toileting schedule matched to the individual’s voiding patterns based on their voiding diary. The toileting schedule is assigned to fit a time interval that is shorter than the person’s normal voiding pattern and precedes the time period when incontinent episodes are expected [Moore et al 2013] 4.3.D. Prompted voiding: a caregiver education program in combination with a scheduled voiding regimens, typically every two hours [Moore et al 2013] 4.3.E. Distraction techniques: doing something that takes the mind off the condition. Distraction techniques utilized in urgency may include (but are not limited to) count backwards from 100 in 7 seconds, recite a poem, do breathing exercises, read or work. 4.3.F. Urgency suppression techniques: To use suppression techniques as described in using distraction in order to suppress the urgency (medical dictionary on line). A PFM contraction may inhibit urgency and detrusor contraction 4.3.G. Double voiding: The patient is taught to urinate, relax and attempt to urinate again [Medical dictionary on line] 4.3.H. Bowel habit training: The training aim to establish a regular, predictable pattern of bowel evacuation by patient teaching and adherence to a routine to achieve a controlled response to bowel urgency [NICE guidelines? Sultan]. 38 Footnote: A bowel habit intervention may: encouraging bowel emptying at a specific time of day, mainly after a meal (to utilise the gasterocolic response, encouraging people to adopt a sitting or squatting position where possible while emptying the bowel and teaching people techniques to facilitate bowel evacuation and stressing the importance of avoiding straining [REF: NICE Guidelines, 2007; Norton et al, 2010; NIH Guidelines, 2013] 4.4. EXERCISE/EXERCISE TRAINING NEW Exercise is a form of leisure- time activity that is usually performed on a repeated basis over an extended period of time (exercise training) with specific external objectives such as improvement of fitness, physical performance, or health [Bouchard et al., 1994. S. 78]. Exercise training includes: endurance training, strength training, flexibility training and motor control (including balance), all of which may apply to the pelvic floor muscles. 4.4.A Therapeutic exercise Exercise interventions directed toward maximizing functional capabilities. A broad range of activities intended to improve strength, range of motion (including muscle length), cardiovascular fitness, flexibility, or to otherwise increase a person’s functional capacity [Bottomley, 2013] (i) Rehabilitation / re-education Helping individuals regain skills and abilities that have been lost as a result of illness, injury or disease, disorder, or incarceration. The restoration of a disabled individual to maximum independence commensurate with his or her limitations [Bottomley 2013]. 39 4. 4.B. Mode of exercise training: not only the type of activity to be performed (for instance, fast walking, jogging, or swimming, strength training), but also the temporal pattern of activity that is recommended (that is, continuous or intermittent activity), with a detailed specification of the duration of exercise and rest periods in the case of intermittent activity bouts [Bouchard et al., 1994.s. 78] (i) Muscle training: exercise to increase muscle strength, power or endurance. a. Strength training: training with high resistance (close to maximal contractions) and few repetitions with the aim to increase muscle volume and neural adaptations b. Resistance: the amount of force opposing a movement [Kent, 1998,s. 430] c. Resistance devices: any object used to increase resistance to contraction e.g. hand weights d. Vaginal resistance device: objects inserted into the vagina or rectum that are inflated to increase resistance to contraction e. Muscle endurance training: training with low load and high number of repetitions or holding the contraction over time f. Muscle power training: speed changes little with training. Thus, power is increased almost exclusively through gains in strength [Wilmore and Costill 1999] 40 g. Overload: a situation in which the body is required to perform exercise beyond that which the neuromuscular system is accustomed to during routine activities. A training adaptation occurs in response to a progressive “overload” [Kraemer & HSkkinen, 2002,s. 12] h. Progressive overload: the gradual increase of stress placed upon the body during exercise training [ACSM, 2009] i. Detraining: cessation of training, but also planned or unplanned reduced volume or intensity of training [Fleck & Kraemer 2004]. j. Maintenance training Maintenance training refers to a program designed to prevent loss of previous level of functioning. k. Isometric/static contraction: a muscular action during which no change in the length of the total muscle or joint angle takes place [Fleck & Kraemer, 2004s. 14] l. Isotonic contraction: in an isotonic contraction, the tension developed by the muscle remains almost constant while the muscle changes its length [Tortora & Derrickson, 2009s. 323] m. Eccentric contraction: a muscular action in which the muscle lengthens in a controlled manner [Fleck & Kraemer, 2004, s.40] 41 n. Repetition: the completion of a whole cycle from the starting position, through the end of the movement and back to the start. (Kraemer & HSkkinen, 2002)s. 14. E.g. one PFM contraction with relaxation o. Set: the number of times the desired number of repetitions is performed (Howley, 2001). E.g. 3 sets of 12 PFM contractions p. Supervised pelvic floor muscle training: a PFM training program taught and monitored by a health professional/clinician / instructor. q. Individualized pelvic floor muscle training: an individual PFM program aimed to improve the specific deficiencies in PFM structure or function based on assessment of the woman’s ability to contract the PFM r. Group pelvic floor muscle training: PFM training conducted in an exercise class [Bø et al 1990]. Class participation may occur with or without prior individualized PFM instruction. s. Home training/home PFM exercise program: is an unsupervised PFM training program which the individual performs at home. t.Weighted vaginal cones: objects of different shapes, sizes and weight which are inserted into the vagina above the level of the PFM with the aim of providing sensory biofeedback and load on the PFM to increase muscle recruitment and strength [Plevnik 1985]. 42 Footnote:The original shape was conical, however different shapes are currently available. Maintenance of the weight in position can be challenged via different body positions and activities. (iii) Facilitation technique: any method to increase recruitment/response of a non-responding muscle. In case of non-contractile or very weak PFMs, this may include a quick stretch to the PFM with tapping or stretching the PFM digitally. An overflow effect from a strong contraction of neary synergistic muscle (e.g. gluteals/hip adductors and external rotators) may also assist facilitation or recruitment of PFMs 4.4.C. Dose-response issues related to exercise training (i) Dose- response: amount/volume of training and its effect on, the speed of, and degree of effect of the training program (ii) Frequency: the number of activity sessions per day, week, or month[Howley, 2001]. (iii) Duration: the unit of time (number of seconds / minutes) of activity in each repetition or session, a 10 sec PFM contraction [Howley, 2001]. It also refers to the length of the whole training period (intervention); e.g. 3 / 6 months. (iv) Intensity: the amount of resistance used or effort associated with the physical activity [Howley, 2001]. For strength training, it is often expressed as % of “one repetition maximum: 1RM (the maximum load a person can lift once) , e.g 70% of max [Kraemer & Hakkinen, 2002, s. 14]) 43 (v) Session / bout: the block of time devoted to the training e.g a one hour session[Kraemer & HSkkinen, 2002, s.14] 4.4.D. Relaxation training (i) Relaxation: the ability to control muscle activity such that muscles not specifically required for a task are quiet, and those which are required are fired at the minimal level needed to achieve the desired results [Coville 1979, p. 178]. Relaxation “can be considered as a motor skill in itself because the ability to reduce muscle firing is as important to control as is generation of firing” [p. 177) (Alter, 2004, p. 97] a. General relaxation technique: a technique which involves the whole body, with the aim to effect a global relaxation including decrease in skeletal and smooth muscles, decrease in heart rate, respiration rate and increase in parasympathetic activity. General relaxation techniques can also be used with the aim to relax local muscles b.Progressive muscular relaxation ( also known as Jacobsen’s technique): monitoring tension in each specific muscle group, by contracting, then relaxing the tension, with attention paid to the contrast between tension and relaxation. c.Meditation: a practice of concentrated focus upon a sound, object, visualization, the breath, movement, or attention itself in order to increase awareness of the present movement, reduce stress, promote relaxation, and enhance personal and spiritual growth [Astin JA et al 2000]. 44 d. Mindfulness: intentionally bringing one's attention to the internal and external experiences occurring in the present moment, and is often taught through a variety of meditation exercises [Baer 2003]. (ii) EMG relaxation techniques: Techniques to decrease muscle activity or activation through a variety of methods including conscious effort to relax and reduce EMG activity (iii) Specific relaxation technique: relaxation targeted towards a specific muscle or muscle group (e.g. the PFM) for a local effect. EMG down training and stretching are the methods often used[ref] 4.4.E. STRETCHING (i) Stretching (also referred to as flexibility training when the method is used on skeletan muscles where increased range of motion over joints is the aim): the application of an external force to muscle and connective tissue to elongate it in the direction opposite to it’s shortened position. This can be done in parallel with or perpendicular to muscle fibre direction. For the PFM this can be applied as a widening of the levator hiatus in the axial plane (laterolaterally) via a digit or use of dilator, or a caudal movement (via a straining/bearing down manoeuvre) in the sagittal plane. a. Dilator therapy: A conical or cylindrically-shaped device (made of an inert material) inserted intra-vaginally or intra-anally, with the aim to increase the flexibility or elasticity of the soft 45 tissues via application of a prolonged elongation or stretch. Dilators may also be used as a desensitizer device, in order to reduce fear, anxiety or pain associated with vaginal touch. 4.4.F. Functional training: training in tasks of daily living and self-care activities e.g. squatting to train quadriceps and gluteal muscles (i) Functional PFM training: training and exercises which incorporate a correct PFM contraction into activities of daily living such as lifting, transferring out of bed, or sneezing. A PFM contraction prior to a rise in intra-abdominal pressure e.g. a cough (“the Knack”) is part of functional PFM training. (ii) Coordination training: the ability to use different parts of the body together smoothly and efficiently” [Oxford dictionary]. Related to PFM training, coordination training means PFM contraction with other muscles or other muscle groups e.g breathing muscles. (iii) Functional mobility training: an intervention directed at improving physical ability to perform a daily task. For voiding / defecation, this may include: gait training, transfer training, stair training, and other mobility training to improve speed and safety in reaching the toilet. 4.5. Biofeedback training 4.5.A. Feedback: sensory information that is available as the result of an activity that a person has performed. It can be provided by an intrinsic source (from within the individual), or an extrinsic source (from the clinician), and can occur concurrently with the activity or post-activity. 46 E.g. verbal information from the clinician to the patient during or following PFM assessment [Shumway-Cook & Woollacott, 1995] Footnote: PFM feedback can be provided by the therapist or patient during manual palpation internally or externally or with a mirror. The purpose of feedback is to increase accuracy of contraction for maximum benefit. 4.5.B. Biofeedback: the use of an external sensor / instrument to provide information to the individual regarding a biological or physiological activity [Smith]. An adjunctive therapy. Footnote: Biofeedback can be either visual, auditory or both. Biofeedback is not a treatment on its own. It is an adjunct to training and can be used to help the patient be more aware of muscle function, and to enhance and motivate patient effort during training [Bø 2007 book]The correct terminology should be PFM strength training or relaxation training with (specify which) biofeedback. Footnote: types of pelvic floor muscle biofeedback include: perianal, vaginal and anal surface EMG, urethral, vaginal or anal manometry, vaginal dynamometry, real-time ultrasound [Bø K 2007]. 4.5.C. EMG Biofeedback Unit Instrumentation (i) EMG signal amplitude: amount of microvolts (uV) a muscle is generating [Cram 1998 page 32] EMG biofeedback units can deliver either the actual amount of EMG activity in (uV) or an average (uV). Clinicians are to be cautious in regard to the interpretation of the information as many factors influence amplitude including muscle activity, skin conductance, and artifact. 47 Footnote: "EMG amplitude does not equal force." [Cram 1998 page 34] More microvolt activity means more muscle activity but does not always mean more strength. (ii) Artifact: extraneous information non- recognizable in EMG signal from sources other than the target muscle such as the environment or other body functions [extrapolated from Cram 1998 pg 67] Footnote: Artifact examples: movement or contact quality artifact, cross talk, heart rate, skin electrode shear, electrode bridging, and others. (iii) Cross talk: muscle activity from nearby muscles which can artificially increase EMG amplitude. A type of artifact [extrapolated from Cram 1998 pg 69] Footnote: minimizing cross talk is essential in research for quality EMG tracings. (iv) Dual channel EMG: use of two channels to monitor two separate muscle or muscle groups at the same time such as the PFM and abdominal muscles with the goal to either promoting synergist activity or to reduce EMG activity of one muscle while increasing the other. (v) Band pass: Limits muscle fiber frequencies that are monitored and displayed in the EMG tracing [extrapolated from Cram 1998 pg 50] 48 Footnote: Recording with surface electrodes is prone to artifact and cross talk. The user should be trained appropriately and understand the limit of the EMG instrument and of the methodology. It is not within the scope of this document to define all EMG terms.Readers are referred to other texts for further terminology [Cram 1998, Schwartz 2003] 4.5.D: PFM EMG Assessment Use and interpretation of surface EMG recording of a muscle for rehabilitation purposes should be done cautiously recognizing the main goal is qualitative description of muscle activation pattern not qualitative diagnosis. (i) Baseline muscle activity: amount of microvolts generated by the target muscle during rest Footnote: baseline EMG reading can be influenced by many factors and therapists must take into account patient's symptoms, digital palpation results, overall tension of the patient, possibility of artifact, and other factors in determining the meaning of the baseline muscle activity. (ii) Peak microvolts: highest EMG amplitude achieved (iii) Slow recruitment: slow initiation of muscle activation contraction Footnote: slow recruitment can be symptomatic in leakage during coughing and sneezing when a quick muscle contraction is needed to counteract increased intra-abdominal pressure. 49 (iv) Slow de-recruitment or slow latency to return to baseline: slow relaxation of the muscle contraction [Schwartz page 653]. Footnote: slow de-recruitment can be indicative of overactive PFM (v) Inconsistent resting baseline: variation of baseline between contractions, between sets, or between days is often related to a change in patient symptoms. (vi) Excessive accessory muscle contraction: increased amplitude in accessory muscles often resulting in cross talk and indicative of poor isolation of target muscle contraction. 4.5.E: PFM EMG training (i) Up-training: EMG biofeedback training to increase the EMG activity of a underactive muscle with low EMG activity [Cram 1998 page 393] Footnote: The general principles of strength training are the same with and without biofeedback. (See mode of exercise training and dose response issues) (ii) Down-training: EMG biofeedback training to decrease EMG activity and relax muscle [extrapolated from Cram 1998 page 175] Footnote: The general principles of relaxation training are the same with and without biofeedback 50 4.6. MANUAL THERAPY A clinical approach utilizing skilled, specific hands-on techniques, including but not limited to massage, manipulation or mobilization. Footnote: It is used to diagnose and treat soft tissues and joint structures for the purpose of modulating pain; increasing range of motion; reducing soft tissue oedema; inducing relaxation; improving contractile and non-contractile tissue extensibility, and/or stability; facilitating movement, and improving function. This broad group of skilled hands-on treatments can be divided into two groups: joint therapies and soft tissue therapies. 4.6.A. Joint therapies (i) Mobilization: skilled passive movement of a skeletal joint which includes graded passive oscillations at the joint to improve joint mobility[Bottomley, 2013?]. (ii) Manipulation: A passive (for the patient) therapeutic movement, usually of small amplitude and high velocity, at the end of the available joint range [Bottomley, 2013, p. 110]. Manipulation is a sudden small thrust that is controlled by the clinician. Footnote; neither mobilization or manipulation should be used when referring to muscle 4.6.B Soft tissue therapies (i) Touch de-sensitization: use of finger / hand, vibration or device to reduce hypersensitivity of soft tissues to touch / contact 51 (ii) Massage: the manipulation of the soft tissues of the body for the purpose of affecting the nervous, muscular, respiratory, and circulatory systems [Bottomley 2013] a. Myofascial release techniques: The use of deep friction and stroking of the fascia of the body to improve the ability of the fascia to deform and move within the body [Bottomley, 2013, p. 497] b. Skin rolling: a manual technique in which skin is pulled away from the underlying structures and elongated in various directions. c. Scar massage: a specific application of soft tissue moblization to adherent scar. d. Perineal massage: intra-vaginal massage by the woman, her partner or the clinician. Technique includes alternating downward and sideward pressure, using thumb and forefinger and a natural oil, with the aim to stretch and elongate the tissue in preparation for vaginal childbirth, or for treatment of adherent scaring in the perineum [Beckmann and Stock 2013] e. Transverse friction: the operator's fingertip is placed on the exact site of the lesion and rubbed hard across the direction of the fibers of the affected tissue [Cyriax] f. Thiele’s massage: Per rectal digital massage of levator ani, sweeping lengthwise along the muscle fibres. Massage is begun lightly, and pressure is increased as tenderness decreases [Thiele 1937] 52 g. Trigger point treatment (TrP): (sometimes called myofascial trigger point treatment : soft tissue mobilization specifically targeting trigger points and may include ischemic pressure, massage, myofascial release, electrotherapy, ultrasound, laser, spray-and-stretch, injection (variety of chemicals including local anesthetic, botox or steroids), dry needling (insertion of solid needle into the TrP), and stretching. 4.6.C. Other (i) Cold treatment / cryotherapy: the application of ice for therapeutic purposes. It is used in the initial management of acute musculoskeletal injuries, in order to decrease oedema through vasoconstriction and reduce secondary hypoxic injury by lowering the metabolic demand of injured tissues [Brukner et al 2012] (ii) Heat treatment (moist or dry): the application of heat to a body part, with the aim to relieve pain and/or stiffness. Usually applied when an injury is older than 48 hours. 4.7 ELECTRICAL THERAPY Use of electric potential or currents to elicit therapeutic responses 4.7.A. Electrical muscle stimulation (EMS) (also known as neuromuscular electrical stimulation (NMES) or electromyo stimulation): the application of electric impulses directly to striated pelvic floor muscle (end-plate) to facilitate contraction. EMS is often referred to as pelvic floor muscle electrical stimulation (PFES) or functional electrical stimulation. PFES is the 53 application of electrical current to the pelvic floor muscle [SCHREINER, Lucas et al 2013]. All of these stimulations may (indirectly) cause inhibition of the detrusor contraction. 4.7.B. Mode of application (i) Surface electrodes: non-invasive placement of electrodes a. Non-invasive electrical nerve stimulation or Transcutaneous electrical stimulation [Berghmans 2002; Brubaker 2000; Jabs 2001] or transcutaneous electrical nerve stimulation (TENS): the application of mild intensity electrical energy to stimulate cutaneous and peripheral nerves, via suprapubic, perineal or sacral placement of electrodes, or other external sites, or intravaginal or intra-anal plug electrodes. There are two main types of electrical stimulation with surface electrodes: - Long-term or chronic electrical stimulation is delivered below the sensory threshold. It aims to inhibit detrusor activity by afferent pudendal nerve stimulation. The device is used 6 to 12 hours a day for several months [Eriksen 1989] - Maximal neuromuscular electrical stimulation applies a high-intensity stimulus, set just below the pain threshold. It aims to improve urethral closure, via striated muscle recruitment. Detrusor inhibition by afferent pudendal nerve stimulation has also been suggested as a mechanism of effect [Berghmans 2002]. Maximal electrical stimulation uses either faradic or interferential current stimulators, is applied over short duration (15 to 30 minutes), is used several 54 times per week (and up to 1 to 2 times daily), and may be provided via in-clinic application or via portable devices at home) [Yamanishi 1997; Yamanishi 1998; Yamanishi 2000]. (ii) Percutaneous electrical nerve stimulation (PENS): a therapeutic modality that stimulates peripheral sensory nerves in the soft tissue performed with a (few) needle electrode(s) that are placed in close proximity to the area to stimulate []. - Percutaneous neuromuscular electrical stimulation (e.g. posterior tibial nerve stimulation): a peripheral neuromodulation technique, in which the nervus tibialis posterior is electrically stimulated three fingerbreadths above the medial malleolus, via insertion of a percutaneous needle electrode. This is coupled with an adhesive reference surface electrode placed near to the needle. This intervention is offered to patients with overactive bladder (OAB) [Govier 2001; Janknegt 1997; van Balken 2001]. 4.7.C. Electrophysiological parameters (i) Electrical Current: The flow (current) of electrons (electricity) from an electron source (stimulator) the wires and electrodes used to deliver such an electrical current to soft tissues [Belanger, 2010 p. 70] There are 3 types of current: direct, alternating and pulsed. – -Direct: The continuous, unidirectional flow of charged particles for 1 second or longer, the direction of which is determined by the polarity selected. Polarity refers to two oppositely charged poles, one positive and one negative. Polarity determines the direction in which current flows [Belanger, 2010 p71]. 55 -Alternating: The continuous, bidirectional flow of charged particles, for one second or longer, relative to the isoelectric baseline [Belanger, 2010 p71]. -Pulsed: The non continuous, interrupted and periodic flow of direct (DC) or alternating (AC) currents [Belanger, 2010 p.71]. Currents used in therapy a.Faradic current: is an alternating and interrupted low frequency current capable of stimulating (depolarizing) nerve fibers through the skin using surface stimulating electrodes. It is used to stimulate innervated muscles causing them to contract [APTA online definition]. b. Transcutaneous electrical nerve stimulation (TENS): an alternating and interrupted low frequency current capable of stimulating (depolarizing) nerve fibers through the skin using surface stimulating electrodes for pain modulation or pain relief [Belanger, 2010 p278] c.Interferential current: designated under the acronym of IFC, is defined and described as a mediumfrequency, amplitude modulated electrical current that results from the interference (hence the word interferential) caused by crossing two or more medium frequency alternating sine-wave currents with different carrier frequencies. The carrier frequency of theses medium alternating sine wave currents ranges between 2000 and 5000 cycles per seconds [Belanger, 2010 page 359]. 4.7.D. Neuromuscular Electrical stimulation parameters 56 Footnote: Depending on the particular device being used, type of electrical current, the specific health problem and condition being treated, the individual’s needs and circumstances, many electrical stimulation parameters may be adjusted by the therapist administering the treatment. (i)Pulse frequency (or rate): The number of pulse cycles) that are generated per unit of time (seconds). This is reported as hertz (Hz) [Belanger 2010?]. (ii) Pulse width: the determined period of time elapsing from the beginning to the end of one pulse cycle, usually express in microseconds or milliseconds [Belanger, 2013 p. 72]. (iii) Current amplitude: the magnitude of current relative to the isoelectric baseline, expressed in amperes (A). the current amplitude of therapeutic electrical stimulators ranges in micro to milliamperes [Belanger, 2013p.75]] (iv) Train: the continuous series of pulse cycles over time, usually lasting seconds. For example, a train of impulses may be the results of successive pulse cycles delivered at 50 cycles per seconds for a duration of 5 seconds [Belanger, 2013 p.76] (v) Train ramp-up time and ramp-down time: ramp-up time is the time elapse from the onset (or baseline) to plateau current amplitude (or maximum) of the train, whereas ramp-down time is the time elapsed from the plateau current amplitude to zero baseline [Belanger, 2010 p78] 57 Footnote: The slower the current intensity rise to the pre-set amplitude or threshold level, the more comfortable the stimulation may feel. Conversely, the faster the ramp, or the more vertical the ramping up signal, the more discomfort may be felt. (vi) Duty cycle (D): It is the ratio of ON-time to the summation of ON-time + OFF time, expressed as a percentage (duty cycle = (ON)/(ON +OFF time) x 100. E.g.: a duty cycle of 20% is calculated when the ON- and OFF times equal 10 and 40 seconds, respectively [Belanger, 2010 p. 77]. (vii) Impedance (electric resistance): This term, designated by the letter Z and measured in ohms, refers to the opposition of our biological tissues to the flow of an electrical current. [Belanger, 2010 p.70] (viii) Evoked potentials: electrical potentials recorded from the nervous system following a delivered stimulus. Not pertinent for estim as an intervention 4.8. MAGNETIC STIMULATION (or Extracorporeal Magnetic Innervation (ExMI): a pulsed magnetic technology developed for the transmission of nerve impulses which aims to cause pelvic floor muscle contraction. Persons receive therapy by sitting in a chair, which contains the device that produces the pulsing magnetic fields. 4.9. MECHANICAL DEVICES 4.9.A. Intravaginal devices: devices to support the bladder neck to correct urinary stress incontinence. These can be traditional tampons, pessaries and contraceptive diaphragms and 58 devices designed specifically to support the bladder neck (removable reusable intra-vaginal ring or single-use disposable devices [Cottenden 2013] 4.9.B. Anal plugs: types of containment devices that aim to block the loss of stool to control faecal incontinence. Plugs come in different designs, sizes and composition such as polyurethane and polyvinyl-alcohol [Deutekom & Dobben,2012]. Footnote: Sultan et al []Treminology for female Anorectal Dysfunction 4.9.C. Urethral suppositories/ urethral inserts (i) Urethral plugs: Intra-urethral devices are types of containment products that aim to block urine leakage [Lipp et al, 2011]. 4.9.D. Pessaries: intravaginal devices used to try to restore the prolapsed organs to their normal position and hence to relieve symptoms. Vaginal pessaries can be broadly divided into two types: support pessaries (Ring, Ring with support, Gehrung, Hodge) and space filling pessaries (Doughnut, Gellhorn, Cube, Inflatable pessaries) [Lipp et al., 2011; Adams et al., 2004; Oliver et al., 2011] 4.10. HYGIENE 4.10.A. Bladder hygiene: Prevention of urinary tract infection by using techniques such as wiping the urethral meatus with clean wipes in an anterior-to-posterior direction after voiding, wearing clean underwear, washing the area with water and soap on a regular basis, and emptying the bladder within 1 hour from sexual intercourse. (SGOC practice guidelines on recurrent 59 urinary tract infection. [JOCG 2010; 250: 1082-90) (Medline Plus, by the National Institute of Health at: http://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000391.htm. ] 4.10.B.Vulval hygiene: maintaining a clean perineum by means of washing the area with water and soap on a regular basis, and wearing cotton underwear [Mosby's Medical Dictionary, 8th edition. 2009, Elsevier]. To avoid vulval irritation, shampoo, perfumed creams or soap should be avoided in the vulval area [www.nva.org] 4.10.C. Vaginal lubricating agents: Pharmacologic preparations aimed to reduce friction between the vagina and the male penis during sexual intercourse and thereby alleviate dyspareunia [Braunstein and van de Wijgert 2005], or to reduce discomfort associated with a clinical (per vaginum or per rectum) examination. Natural plant-based oils may be used instead of lubricating gels. 4.11. AIDS AND APPLIANCES 4.11.A. Absorbent products: products which have been specifically developed to help manage leakage or soiling such as absorbent pads and pants, absorbent bed sheets and chair covers Cottenden 2013]. [http://www.nevdgp.org.au/info/incontinence/i_aids.htm] 4.11.B. Catheters: Urinary catheters are small tubes inserted via the urethra or into the bladder suprapubically, to allow drainage of urine. Catheters are made of plastic, latex, teflon or silicone, and may be impregnated with antiseptic or antibiotics solution [Schumm & Lam, 2008] 60 (i) Self-catheterization (clean intermittent self-catheterisation): a procedure performed intermittently by a patient to empty the bladder by inserting a catheter into the urethra when normal voiding is not possible or the bladder cannot be emptied completely. 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