q 2000, British Geriatrics Society Age and Ageing 2000; 29: 159–164 Does treatment of constipation improve faecal incontinence in institutionalized elderly patients? PHILIPPE CHASSAGNE, ALAIN JEGO, PHILIPPE GLOC , CORINNE CAPET, CHRISTOPHE TRIVALLE, JEAN DOUCET, PHILIPPE DENIS1, ERIC BERCOFF Service de Médecine Gériatrique and 1Service de Physiologie Digestive et Urinaire et Groupe de Recherche sur l’Appareil Digestif (GRAD), Centre Hospitalier et Universitaire de Rouen, 76031 Rouen Cedex, France Address correspondence to: P. Chassagne. Fax: (+33) 2 32 88 91 30. Email: [email protected] Abstract Objective: to evaluate whether faecal incontinence can be improved by treatment of constipation in elderly patients with faecal incontinence associated with impairment of rectal emptying. Design: a prospective randomized study with a 2-month follow-up. Setting: five long-term care units. Subjects: 206 patients with daily faecal incontinence associated with chronic rectal emptying impairments such as faecal impaction received either a single osmotic laxative (group I) or an osmotic agent along with a rectal stimulant and weekly enemas (group II). Measurements: episodes of faecal incontinence and associated details of soiled laundry (used as indicators of the workload for caregivers). We performed periodic digital rectal examinations on group II patients to evaluate whether treatment resulted in complete and long-lasting rectal emptying. We compared data between groups and in group II between persistently constipated patients and patients with complete rectal emptying. Results: the frequency of faecal incontinence did not significantly differ between the two groups. The 23 patients in group II who had complete rectal emptying had 35% fewer episodes of faecal incontinence and 42% fewer incidents of soiled laundry than the rest of the group. Conclusions: when long-lasting and complete rectal emptying is achieved by laxatives, the number of episodes of faecal incontinence as well as the workload for caregivers is reduced. Keywords: constipation, elderly, faecal incontinence, institutional care Introduction Faecal incontinence is a common cause of institutionalization [1–3] with important psychological consequences [4–6] and economic impact [6, 7]. Its prevalence ranges from to 30% in long-term care units [8, 9] to 47% in psychogeriatric units [10]. Faecal impaction [11–14] is a major cause of faecal incontinence in this population and its prevalence is about 30% [15–17]. In institutions faecal impaction is particularly common in demented patients [13] and those with severe mobility impairments [17, 18]. Although faecal impaction is frequent, recurrent and a cause of faecal incontinence, little has been published on its treatment, especially as a way to reduce the occurrence of faecal incontinence. Theoretically, patients with overflow incontinence [13] could benefit from treatment of constipation if complete and long-lasting rectal emptying could be achieved [19]. The aim of this study was to evaluate whether the treatment of constipation in elderly patients with faecal incontinence, secondary to rectal emptying impairments, is effective in decreasing the frequency of faecal incontinence and, as a result, the workload of their caregivers. Methods Subjects From 751 residents of five long-term care units between March and May 1998, we selected 206 patients aged 65 years or older with faecal incontinence and impaired 159 P. Chassagne et al. rectal emptying. Faecal incontinence was defined as at least one involuntary loss of faeces per week [3]. Impaired rectal emptying was based on at least one episode of faecal impaction diagnosed in the past 2 months (n = 58) or on a history of functional obstructed defecation. The diagnosis of faecal impaction was based on a digital rectal examination, while functional obstructed defecation was defined [18] as a difficulty in defecating requiring manual disimpaction of stools (n = 21), a feeling of anal blockage (n = 45) for at least 12 months or the identification of a rectum that was persistently full of faeces on digital rectal examination (n = 82). We questioned patients and consulted their medical records. We noted data suggesting cognitive impairment (e.g. patients with moderate to severe but daily cognitive impairment with disorientation and memory defects). We assessed patients for mobility using a functional scale [20] and then stratified them into two groups: those who were unable to get out of bed or to walk alone and those who were completely ambulatory. A digital rectal examination was performed on each patient to check and, if necessary, achieve rectal emptying. All laxatives were stopped 48 h before the beginning of the study. We randomized patients who fulfilled the criteria into two groups in each centre. Those in group I received of 30 g per day of lactulose by mouth. Those in group II received 30 g of lactulose, a daily glycerine suppository (Eductyl) and a tap-water enema once a week. The appropriate local committee for human research approved the study. Follow-up and measurements Follow-up was performed by the nursing staff of each institution for 2 months. We investigated the frequency (defined as the number of episodes of loss of faeces per patient per day) and consequences of faecal incontinence, and the effectiveness of the treatment. The assessment of the consequences of faecal incontinence was based on details of soiled laundry (including the number of times that clothes and/or bed linen were changed) and on time that the nursing staff spent managing patients (either treating them or checking information). We assessed the effectiveness of the treatment in achieving complete and lasting rectal emptying by carrying out rectal digital examinations every 10 days in group II patients. Patients were classified as ‘responders’ when at least three consecutive digital rectal examinations showed complete rectal emptying and as ‘non-responders’ if the examinations showed persistent rectal loading with faeces. We excluded patients who missed treatment or follow-up for more than 48 h. Each institution was 160 visited twice a week by a physician from the coordination study group who did not work at the institution, to check all registered information. Nonlaxative therapeutic management of constipation by usual nursing staff practices such as physical exercise, daily fibre supplementation (given to two patients in group I and three patients in group II) or use of pads was left to the discretion of the staff. Statistical analysis Characteristics of the two groups were compared using the x2 test for categorical variables and student’s t-test for continuously measured variables. To make sure that the treatment was the same for both groups and had the same duration, individual information was checked, starting 7 days after treatment had begun. We performed statistical analysis of data after 5 and 8 weeks of treatment using the Mann–Whitney nonparametric test on the sample sizes of patients still included in the study. We performed analyses on a Macintosh computer using Stat Graphics statistical software package. Results Patient characteristics Of 206 patients selected, data from 178 were available for analysis after the first week of treatment. The following were excluded: 19 with severe diarrhoea, one who had died and eight who refused to participate. Among the 28 excluded patients, nine were in group I and 19 in group II (P < 0.05). In group II diarrhoea was directly attributable to laxatives. Characteristics of the 178 remaining patients are shown in Table 1. There was no statistical difference in the percentages of patients in each group with altered mobility or cognitive decline. Cohort characteristics of constipation and faecal incontinence are shown in Table 2. Twenty-eight patients in group I and 30 in group II had had at least one incident of faecal impaction in the last 2 months (P > 0.05). In both groups 40% of patients had had daily faecal incontinence for more than 2 years. Comparison of the study groups after 5 and 8 weeks of treatment After 5 weeks of treatment, 123 of the original 178 subjects remained in the study. Sixty-one of these were in group I and 62 in group II. We excluded 55 patients due to death (n = 10), diarrhoea (n = 10) or because they had missed follow-up (n = 35). The number of patients excluded due to an incomplete follow-up was significantly (P < 0.01) higher in group I (n = 25) than in group II (n = 10). Faecal incontinence in institutional care Table 1. Baseline characteristics of patients (n = 178) Table 2. Characteristics of faecal incontinence and constipation in the studied population (n = 178) at the beginning of the statistical analysis a Group .............................................. I (n = 93) Variable II (n = 85) n (and %), by groupa P value .................................. ....................................................................................................... Age, years Mean 6 SD 85.9 6 6.1 84.7 6 6.6 Range (66–99) (69–98) I (n = 93) Variable II (n = 85) P value ....................................................................................................... History of faecal impaction Yes 58 (62) 59 (69) No 25 (27) 20 (23) Not reported 10 (11) 6 (7) Gender (female), n (and %) 77 (83) 68 (80) 0.54 0.77 Cognitive impairment, n (and %) Duration of faecal incontinence (months) Yes 67 (72) 63 (75) No 18 (19) 17 (20) Not reported 8 (9) 5 (5) <6 24 (26) 24 (28) 6–24 19 (20) 18 (21) > 24 50 (54) 43 (51) 0.78 Mobility, n (and %)b 0.90 Frequency of faecal incontinence Altered 80 (86) 77 (91) Preserved 13 (14) 8 (9) 0.47 a All subjects received 30 g/day lactulose. Those in group II also received daily glycerine suppositories and weekly enemas. b Patients with altered mobility were unable to get out of bed or walk alone; those whose mobility was preserved remained completely ambulatory. The mean number of episodes of faecal incontinence and soiled laundry did not differ statistically between the groups (Table 3). Comparison of groups for the study variables such as the number of episodes of faecal incontinence according to baseline patient characteristics (for example the number of patients with cognitive and/or mobility impairments) showed no significant differences. After 8 weeks of treatment, 101 patients remained (39 in group I and 62 in group II). All exclusions occurred in group I, mainly because of missing $ 1 episode per day 38 (41) 38 (45) $ 1 episode per week 47 (51) 44 (52) 8 (9) 3 (4) Not reported 0.36 a All subjects received 30 g/day lactulose. Those in group II also received daily glycerine suppositories and weekly enemas. follow-up. Comparison of the two groups did not show a statistical difference in the number of episodes of faecal incontinence or in the amounts of soiled laundry. Comparison of treatment effectiveness after 5 weeks We performed a periodic digital rectal examination in 59 of the 62 patients in group II (96.7%). Twenty-three of these 59 patients (40%) were ‘responders’ (Table 4). Table 3. Comparison of the number of episodes of faecal incontinence and soiled laundry between groups Groupa .............................................................................................. I (n = 61) Variable II (n = 62) P value ........................................................................................................................................................................................................................ No. of episodes, (n)/mean 6 SD (1461)/24 6 11.5 (1492)/24 6 10.8 0.9 Faecal incontinence (soiling) (702)/12 6 9.9 (766)/12 6 12.7 0.63 b (4881)/80 6 16.1 (4843)/78 6 20.7 0.55 0.85 0.84 2.9 2.8 Faecal incontinence (loss of faeces) Soiled laundry Incidents/per day/per patient Faecal incontinence (loss of faeces) b Soiled laundry a All subjects received 30 g/day lactulose. Those in group II also received daily glycerine suppositories and weekly enemas. Number of changes per day (of bedding and or clothing) due to faecal incontinence. b 161 P. Chassagne et al. Table 4. Comparison of numbers of episodes of faecal incontinence and soiled laundry between patients who did and did not responda after 5 weeks of treatment with lactulose, glycerine suppositories and enemas Responders (n = 23) Variable Non-responders (n = 39) P value ........................................................................................................................................................................................................................ No. of episodes, (n)/mean 6 SD Faecal incontinence (loss of faeces) (331)/14 6 9.1 (795)/22 6 11.7 < 0.02 Faecal incontinence (soiling) (103)/4 6 7.1 Soiled laundryb (948)/41 6 19.4 (295)/8 6 6.2 > 0.05 (2593)/72 + 28.3 < 0.001 0.51 0.78 1.5 2.6 Incidents/per day/per patient Faecal incontinence (loss of faeces) b Soiled laundry a Patients were classified as ‘responders’ when at least three consecutive digital rectal examinations showed complete rectal emptying and as ‘non-responders’ if the examinations showed persistent rectal loading with faeces. b Number of changes per day (of bedding and or clothing) due to faecal incontinence. Among ‘responder’ patients, 331 episodes of faecal incontinence were registered compared with 795 in ‘non-responders’ (P < 0.02). The responders showed a 35% reduction in frequency of faecal incontinence and a 42% reduction in incidents of soiled laundry. After 8 weeks of treatment, 13 (30%) of the 62 patients remaining in group II were still responders. Among these patients, 504 episodes of faecal incontinence were reported, significantly fewer (P < 0.05) than the 1272 episodes recorded among the nonresponders. There was no significant difference between responders and non-responders in the number of incidents of soiled laundry. The time necessary for nurses to complete the standardized individual questionnaire was 5 min per day. The time spent in administering an enema ranged from 10 to 20 min and for bathing and dressing from 5 to 20 min (mean 15 min). Discussion In this study we selected a cohort of elderly institutionalized patients with daily faecal incontinence associated with impaired rectal emptying. Our purpose was to evaluate whether the treatment of constipation could improve incontinence in these patients. Because participating patients had chronic constipation, they all received at least an oral laxative agent which had been previously tested in these clinical circumstances [21–23]. We felt that a combination of laxatives and enemas (as provided to group II) would be more likely to decrease the frequency of faecal incontinence in these patients. This was not confirmed by our results. This study could be randomized but not blinded because outcomes were measured daily and because the treatment was provided by the nursing staff. To 162 minimize this potential bias we randomized patients in each centre and ensured that information was checked by an investigator from the co-ordination group who did not work in the unit. This appears to have been successful in that results did not vary between centres. The results may be explained by the baseline characteristics of the population studied. Patients had had chronic constipation and daily long-lasting faecal incontinence for at least 2 years in 40% of cases. As shown in Table 1, these patients also had severe cognitive and mobility impairments, which are both strongly associated with faecal incontinence [8, 10, 14, 24, 25]. In addition, only 40% of the patients in group II were ‘responders’ according to our criteria. This suggests that treatment with an association of laxatives was not well suited to these frail, elderly patients. Other therapeutic regimens that have been assessed for constipation include stimulant laxatives [26] alone or in association with fibre intake and laxative osmotic agents [27] or bisacodyl [28]. However, administration of these oral laxative stimulants should be carefully monitored in elderly patients because of potential side effects, such as malabsorption or dehydration [18]. Treatment of constipated patients with faecal incontinence based on laxatives alone is unsatisfactory, probably because mobility and cognitive impairments may play an important role in faecal incontinence. However, few studies have evaluated non-pharmacological approaches to faecal incontinence such as physical exercise [29] or prompted voiding [30]. Our second objective was to assess whether rectal emptying would be associated with a decrease in the frequency of faecal incontinence in constipated patients with functional chronic rectosigmoid delay. We confirmed this hypothesis. We showed that the number of episodes of faecal incontinence was reduced by 35% when rectal emptying was achieved, Faecal incontinence in institutional care and that the workload for institutional staff (based on details of soiled laundry) decreased by 42%. In a previous study [30] the workload for care-givers was assessed on the basis of cost: at this time (1974) the daily cost of laundry for a patient with faecal incontinence was £8.50. Whatever the treatment of chronic rectal emptying impairment used for patients with faecal incontinence, these results emphasize the importance of carefully defined follow-up techniques. Digital rectal examination is a simple method which should be used to ensure that rectal emptying has been achieved. Rectal examinations seem to be more effective than periodic patient interviews in identifying early signs of recurrent faecal impaction. Indeed, in this population, interviews are limited by cognitive decline and because signs of constipation may not be noticed due to impairment of rectal sensitivity [31, 32]. Patients with faecal impaction have a decrease in the threshold of rectal distension, and this impairment is considered to be the mechanism responsible of overflow faecal incontinence [14, 33]. In these patients, rectal examination seems to be the most suitable method for early detection of acquired faecal impaction and the best adapted for its management. In conclusion, treatment of chronic rectal emptying impairment in patients with faecal incontinence is difficult but effective in decreasing the frequency of faecal incontinence and thus the workload of nursing staff. This treatment can probably be achieved through individually tailored therapeutic programmes associated with strict clinical evaluation based on periodic rectal examinations. 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