Seven-Year Follow-up of the Tension-Free Vaginal
Tape Procedure for Treatment of Urinary
Incontinence
Carl Gustaf Nilsson, MD, PhD, Christian Falconer, MD, PhD, and Masoumeh Rezapour, MD, PhD
OBJECTIVE: To evaluate the long-term cure rates and late
complication rates after treatment of female urinary stress
incontinence with the minimally invasive tension-free vaginal tape operation.
METHODS: Prospective observational, 3-center cohort study
originally of 90 women requiring surgical treatment for
primary urinary stress incontinence. Assessment variables
included a 24-hour pad weighing test, a stress test, visual
analog scale for assessing the degree of bother, and a
questionnaire assessing the subjective perception of the
women on their continence status.
RESULTS: The follow-up time was a mean of 91 months
(range 78 –100 months). Both objective and subjective cure
rates were 81.3% for the 80 women available for follow-up.
Asymptomatic pelvic organ prolapse was found in 7.8%, de
novo urge symptoms in 6.3%, and recurrent urinary tract
infection in 7.5% of the women. No other long-term adverse
effects of the procedure were detected.
CONCLUSION: The tension-free vaginal tape procedure for
treatment of female urinary stress incontinence is effective
over a period of 7 years. (Obstet Gynecol 2004;104:
1259 – 62. © 2004 by The American College of Obstetricians and Gynecologists.)
LEVEL OF EVIDENCE: II-3
During the past decade a number of new minimally
invasive surgical procedures for treatment of female
stress urinary incontinence have been made available for
clinical use. This is perhaps a reflection of modern health
care, which strives to provide the individual and the
society with rapid, resource-saving, and cost-effective
treatment. Not only cure in the sense of dryness but also
quality of life have become important outcome measures
when assessing results of treatment of female urinary
From the Department of Obstetrics and Gynecology, Helsinki University Central
Hospital, Helsinki, Finland; Danderyd Hospital, Stockholm, Sweden; and Department of Obstetrics and Gynecology, Uppsala University Hospital, Uppsala,
Sweden.
The authors recognize Ulf Ulmstead, MD, PhD, deceased March 2004, for his
contribution to this study.
VOL. 104, NO. 6, DECEMBER 2004
© 2004 by The American College of Obstetricians and Gynecologists.
Published by Lippincott Williams & Wilkins.
incontinence. Quality of life can be defined in many
ways, of which one is the absence of short- or long-term
complications in association with cure.
Low cure rates and high complication rates have been
a concern among those studying many of the minimally
invasive procedures. Endoscopic colposuspension, periurethral bulking agents, and needle suspension procedures have been associated with either unacceptable
complications or rapidly declining cure rates1–3
The tension-free vaginal tape (TVT) procedure for
treatment of female stress incontinence has become a
widely used new minimally invasive operation probably
due to the fact that it has been systematically and prospectively evaluated. Numerous reports reveal high rates
of cure in primary cases of stress incontinence,4 – 6 in
recurrent cases,7,8 in cases of mixed incontinence,6,9 and
in cases with intrinsic sphincter deficiency.10 A nationwide survey of the incidence of intraoperative and postoperative complications in connection with the TVT
procedure has been performed in Finland. The results of
this survey indicate a low rate of complications, even
though the learning curve of the performing surgeons
was included in the material.11
High long-term cure rates enhance the cost-effectiveness of a given treatment. Five-year follow-up results of
the TVT procedure have been published.12 The cure
rate of 85% corresponds very well with those of our most
effective traditional, but more invasive, surgical incontinence procedures. The aim of the present study was to
evaluate the continence status 7 years postoperatively of
the women included in one of the earliest prospective
clinical trials.
MATERIALS AND METHODS
Ninety consecutive patients suffering from urodynamically proven stress incontinence had a tension-free vaginal tape procedure performed between January 1, 1995,
and October 15, 1996. The trial was a prospective 3-center study in 2 Nordic countries. All women were primary
0029-7844/04/$30.00
doi:10.1097/01.AOG.0000146639.62563.e5
1259
cases of stress incontinence, with no prior incontinence
surgery. Twenty-five women reported symptoms of
urge. Symptoms of urge included frequency more than 8
per day, urgency and nocturia more than 2 per day.
Women with detrusor instability on preoperative urodynamic studies were excluded, as were those with intrinsic
sphincter deficiency, defined as maximal urethral closure
pressure less than 20 cm H2O. Women with grade I
cystocele not requiring surgical intervention were included.
The study protocol included preoperative urodynamic studies (micro tip urethrocystometry and urethral
profilometry) in a sitting position according to previously described techniques13), a stress test (cough provocation) in the sitting or standing position with a bladder
volume of 300 ml, a 24-hour pad-weighing test,14 a 2-day
voiding diary, and residual urine measurements.
At postoperative follow-up visits the stress test, the
24-hour pad-weighing test, and the 2-day voiding diary
were repeated. Postoperative quality of life was assessed
by using a visual analog scale (VAS) where 0 represents
no urinary problems and 100 unbearable urinary complaints.
A questionnaire was used in which the women stated
whether they felt that they were cured of their incontinence or that they were improved or that treatment had
failed. The women were also asked whether their continence situation was unchanged, improved, or worse
compared with the situation at their previous 5-year
follow-up visit.12 Changes in medical history since the
5-year visit were recorded, and a gynecologic examination was performed.
The TVT procedure was carried out as described in
detail previously.15 All operations were performed under local infiltration anesthesia using 0.25% prilocaine
with epinephrine. The standard TVT set with a polypropylene tape was used (Gynecare TVT, Ethicon Inc.,
Somerville, NJ). Cystoscopy was performed twice during the operation, after each retropubic pass of the TVT
needle to detect bladder injuries. Adjustment of the
tape—the tension test—was performed by using the cough
test. The patients were asked to cough strongly at a
bladder volume of 300 ml. A few drops of saline were
allowed to escape the external meatus of the urethra to
avoid postoperative voiding difficulties. Postoperatively
the patients were regarded as objectively cured if they
had a negative stress test and a negative 24-hour padweighing test (less than 8 g per 24 hours).
The ethics committees of the 3 centers, Helsinki University Hospital, Danderyd Hospital, Stockholm, and
Uppsala University Hospital, approved the study. All
women gave informed consent to participation in the
trial.
1260
Nilsson et al
Seven Years TVT Follow-up
Table 1. Subject Characteristics
Value
Age at 7-year follow-up (y)
Parity
Menopausal at time of surgery
Urge symptoms preoperatively
Duration of incontinence symptoms (y)
Follow-up time (mo)
60 (42–94)
2 (0–4)
58.8
27.7
13 (2–25)
91 (78–100)
Values are median and (range) or percentage.
RESULTS
Of the original 90 women enrolled in the trial, 3 had died
at the time of the 7-year follow-up visit. Six women lived
in nursing homes, being disabled to a degree that they
could not be evaluated, and 1 woman was completely
lost to follow-up. Eighty women could be reached, 16 of
them only by telephone due to various reasons (living in
nursing homes or moved away from the region). Only
subjective assessment using the questionnaire was performed in these 16 women. Sixty-four women could visit
the clinics and be fully evaluated. The patient characteristics are shown in Table 1.
The mean follow-up time was 91.1 (range 78 –100)
months, which is 7.6 years. Of the 64 women who visited
the clinics, 54 (84.4%) had a negative pad test, 7 (10.9%)
had a positive pad test (range 10 –132g per 24 hours),and
3 women refused to perform the pad test, claiming they
were completely dry.
The stress test was not possible to perform in the
standardized way in 3 women, and the remaining 61
(95.3%) women had a negative stress test. The criteria
for objective cure were met by 81.3% of the clinically
evaluated women.
The results of the subjective evaluation of 80 women
reached for follow-up are presented in Table 2. Both the
objective and subjective cure rate was 81.3%.
Table 2. Subjective Evaluation of Continence Status at
7-Year Follow-up
Outcome
Follow-up status compared with
preoperative status
Cured
Improved
Failed
Change in continence status
since 5-year follow-up visit
Unchanged
Improved
Worse
Claiming dry on stress
VAS score ⬍ 10 (scale 0–100)
n (%)
65/80 (81.3)
13/80 (16.3)
2/80 (2.5)
70/80 (87.5)
4/80 (5.0)
6/80 (7.5)
67/80 (83.8)
54/64 (84.4)
VAS, visual analog scale.
OBSTETRICS & GYNECOLOGY
Table 3. Medical Status of 18 Women With Urge Symptoms at 7-Year Follow-up
Medical status
n
Diabetes mellitus with neuropathy
Serious cardiovascular disease
Asthma
Bladder cancer
Anal incontinence
De novo urge unrelated to any disease
4
4
3
1
1
5
Eighteen (22.5%) of the evaluated 80 women had
symptoms of urge. Table 3 shows the medical status of
these 18 women. Asymptomatic pelvic organ prolapse,
grade I–II and not requiring surgical intervention, was
seen in 5 (7.8%) of the 64 women seen at the clinics.
Recurrent urinary tract infections were reported by 6
(7.5%) of 80 women interviewed. Five (6.3%) of 80
reported de novo urge symptoms. None of the women
complained of voiding difficulties, and no sign of tape
material rejection could be seen or was reported.
DISCUSSION
A commonly encountered problem with new promising
surgical procedures for treatment of female stress incontinence is the difficulty of predicting the effectiveness of a
given treatment over time. A systematic prospective
follow-up allows one to take a closer look at this problem.
Long-term follow-up, however, is associated with a
growing proportion of the original subjects being lost to
follow-up. Interestingly, in our study, of 90 women who
were originally enrolled, 80 were amenable to follow-up
after 7 years and 64 of 90 (71%) could be clinically
evaluated according to the protocol. Only 1 patient was
completely lost to follow-up. Another 9 patients could
not be evaluated due to death unrelated to the treatment
or were severely disabled by illness. Some of the patients
were elderly, a few over 90 years of age. The lower the
rate of those lost to follow-up, the more reliably cure
rates reflect the true durability of effectiveness of treatment in a certain population. Therefore, a cure rate of
more than 80% in a population such as the present one
has to be regarded as reassuring. Long-term cure rates of
around 70 – 80% have been reported for the open Burch
colposuspension operation, regarded as the standard for
traditional incontinence procedures.16,17 Long-term cure
rates for less invasive incontinence procedures such as
needle suspensions and periurethral bulking agents have
been rather disappointing, ranging between 5% and
48%.18 –20 In our current study, 97.5% of the women
regarded the TVT operation as successful. When comparing their continence status at 7 years of follow-up to
that at the prior 5-year visit, 88% felt that the situation
VOL. 104, NO. 6, DECEMBER 2004
was unchanged, but 5% felt that they had improved, and
8% felt that their situation had become worse. This
perhaps reflects changes in health status and life style
more than the actual mechanism of action of the tensionfree tape.
Importantly, no signs of tape erosion or any tissue
reactions indicating tape material rejection were found.
In an aging population many illnesses occur that are
known to affect bladder function, causing symptoms of
overactivity, including incontinence. The patients’ subjective perception of their incontinence status is naturally
affected by these conditions and consequently does not
necessarily reflect the effectiveness with which an operation cures stress incontinence. Eighteen of the women
in the present study presented with symptoms of an
overactive bladder at their 7 years follow-up visit. Thirteen had diseases or conditions that commonly are associated with bladder problems. Only 5 women were
thought to have de novo urge symptoms unrelated to
any known illnesses. Whether the urge symptoms of
these women are directly associated with the TVT operation, performed 7 years earlier, is a question of debate.
In any case, the rate of urge problems with the TVT
procedure seems to be low in comparison with traditional incontinence surgery.2
Quality of life can be assessed in many ways. Generic
instruments for measurement of health-related quality of
life have been relatively insensitive for use in assessing
the impact of urinary incontinence on quality of life and
treatment efficacy.21 The visual analog scale is a generally accepted tool in research concerning measurement
of the impact of disease and effects of medical intervention on health-related quality of life and had also been
successfully used in urinary incontinence studies22–24.
As Stach-Lempinen et al25 have shown, the VAS is an
easy, valid, reproducible measure, which is responsive to
treatment for women suffering from urinary incontinence. We therefore chose this instrument for assessing
quality of life and believe that the VAS nicely reflects
how objectively assessed cure influences women’s perception of changes in quality of life. The absence of
long-term adverse events associated with the TVT operation and high subjective and objective 7-year postoperative cure rates make the TVT operation a recommendable surgical treatment for female stress urinary
incontinence.
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Reprints are not available. Address correspondence to: Carl
Gustaf Nilsson, Department of Obstetrics and Gynecology,
Helsinki University Central Hospital, Haartmaninkatu 2, Helsinki, POB 140,00029 HUS, Finland; e-mail: carl.nilsson@
hus.fi.
Received May 19, 2004. Received in revised form August 19, 2004.
Accepted August 25, 2004.
OBSTETRICS & GYNECOLOGY