Randomized, controlled trial of topical phenylephrine for fecal incontinence in patients after ileoanal pouch construction

INTRODUCTION: Fecal incontinence is experienced by some patients with an ileoanal reservoir pouch. The ₁-adrenergic agonist phenylephrine raises resting anal sphincter pressure in healthy volunteers and may be of value in these patients. METHODS: Twelve patients (7 female), median age 44 (range, 29–67) years were studied. All had fecal incontinence despite a noninflamed pouch of normal size and ultrasonographically structurally normal anal sphincter muscles. Patients were treated with topical 10 percent phenylephrine and placebo gels, allocated in random order in a double-blind, crossover study for two four-week periods. Before and during treatment, maximum resting anal sphincter pressure and anodermal blood flow were measured, a symptom questionnaire was completed, and incontinence score was determined using a validated scale. RESULTS: Six of 12 (50 percent) patients improved subjectively after phenylephrine compared with one on placebo (P=0.07). Four patients had complete cessation of incontinence with active treatment. Phenylephrine significantly reduced the incontinence score (P=0.015). It also resulted in a significant rise in mean maximum resting anal sphincter pressure when compared with placebo (P=0.012). For all 12 patients, mean percent subjective improvement was higher after phenylephrine compared with placebo (P=0.04). There were no side effects. CONCLUSIONS: Topical phenylephrine significantly improves fecal continence in patients with an ileoanal pouch. In some patients it totally eliminates nocturnal episodes. The mechanism of benefit is likely to be one of altered neural sphincter control. This is the first study of the use of a topical pharmacologic agent to treat fecal incontinence and may have a wider application.E. Carapeti is supported by the Robert Luff Foundation. Abstract presented at the meeting of the Association of Coloproctology of Great Britain and Ireland, Jersey Channel Island, June 28 to July 1, 1998.     

Long-term efficacy of biofeedback training for fecal incontinence

PURPOSE: Biofeedback therapy in fecal incontinence has been reported to improve continence in more than 70 percent of patients, but most studies have followed patients for less than two years. METHODS: Patients treated by biofeedback training between 1985 and 1986 were given a questionnaire in 1991, as were incontinent patients who had not entered this treatment program. All were asked for the occurrence, frequency, and severity of incontinence events in the past two weeks. Anamnestic and anorectal manometry data from the initial visit were also compared. RESULTS: Eighteen of 24 treated patients and 40 of 71 untreated patients responded. Of those treated by biofeed-back, 78 percent reported episodes of fecal incontinence as compared with 77.5 percent of those not treated by biofeedback. Severity of incontinence, however, was significantly less (P <0.02) in the treatment group (mean number of events, 0.2/day) than in those without treatment (1/day). In biofeedback-treated patients, it was identical with the frequency and severity reported immediately after therapy. No differences were found with respect to initial clinical data and anorectal manometry between both groups. CONCLUSION: Biofeedback training improves continence in patients not only during treatment and within the first two years but also for several years after therapy.Supported by a grant from the Deutsche Forschungsgemeinschaft, En 50/10.Presented in part at the European Gastrointestinal Motility Symposium, Barcelona, Spain, November 19 to 21, 1992. Published abstract form in the Journal of Gastrointestinal Motility 1992;4:218.     

Long-term results of electromyographic biofeedback training for fecal incontinence

PURPOSE: The aim of this study was to examine the long-term results of electromyographic biofeedback training in fecal incontinence. METHODS: Thirty-seven patients (1 male) received a customised program of 2 to 11 (median, 3) biofeedback training sessions with an anal plug electromyometer. Nine patients had persistent incontinence after anal sphincter repair, a further 8 patients had postsurgical or partial obstetric damage of the sphincter but no sphincter repair, 9 patients had neurogenic sphincter damage, and 11 patients were classified as having idiopathic fecal incontinence. Duration of voluntary sphincter contraction was measured by anal electromyography (endurance score) before and after treatment. A postal questionnaire was used to investigate the following variables: 1) subjective rating on a four-grade Likert-scale of the overall result of the biofeedback training; 2) incontinence score (maximum score is 18, and 0 indicates no incontinence); and 3) rating of bowel dissatisfaction using a visual analog scale (0 to 10). RESULTS: Twenty-two patients (60 percent) rated the result as very good (n=8) or good (n=14) immediately after the treatment period. Median endurance score improved from 1 to 2 minutes (P<0.0001). Median incontinence score improved from 11 to 7, and bowel dissatisfaction rating improved from 5 to 2.8 (bothP<0.0001). After a median follow-up of 44 (range, 12–59) months, 15 patients (41 percent) still rated the overall result as very good (n=3) or good (n=12). The incontinence score did not change during follow-up. Median bowel dissatisfaction rating deteriorated from 2.8 to 4.2 but remained better than before treatment. Poor early subjective rating and the need for more than three biofeedback sessions were predictive of worsening during follow-up. CONCLUSION: We think it is encouraging that in this study biofeedback treatment for fecal incontinence with an intra-anal plug electrode resulted in a long-term success rate in nearly one-half of the patients.     

Combined biofeedback, physiotherapy and electrostimulation for fecal incontinence

Different outcomes are reported in the literature following pelvic floor rehabilitation for fecal incontinence, possibly due to the type of procedure employed, whether biofeedback or physiotherapy or electrostimulation. The aim of the present study is to analyze the results achieved in a group of patients treated with a combination of the three procedures. Thirty-two patients (24 females) affected by fecal incontinence underwent a course of combined rehabilitation (CR); 23 of them had anal surgery prior to CR, for rectal mucosal prolapse and hemorrhoids in most cases. Eighteen had anal manometry before and after CR. Sixteen underwent anal ultrasound prior to treatment. Patients were taught perineal exercises, biofeedback was either sensory or electromyographic, and electrostimulation was performed with a 10–20 MHz endoanal probe. Twenty-seven patients were available for follow-up. The mean incontinence score improved from 4.0±0.8 to 2.1±1.7 (mean±sd) (p<0.001); 19 patients (70%) were satisfied after CR, and 11 (44%) were fully continent. Post-treatment manometry showed an increased amplitude of squeeze pressure in 50% of the cases, whereas 61% had an increase in duration, but only 27% of them had a positive clinical outcome. Rectal evacuation thresholds improved in 55% of the cases and 86% of them had a corresponding positive clinical outcome. At ultrasound, 6 patients showed intact anal sphincters and had a positive outcome following CR. Pelvic floor rehabilitation seems to be effective for the management of fecal incontinence when carried out combining different types of procedures. No significant correlation was found between manometric and clinical response to the treatment. An increase of rectal sensation may be responsible for the clinical improvement. Received: 25 August 2000 / Accepted in revised form: 20 October 2000     

生物反馈治疗大便失禁的疗效评价

目的　评价生物反馈方法治疗大便失禁患者的疗效。方法　对 2 6例大便失禁患者进行生物反馈治疗 ,治疗前后分别做肛肠测压和肌电图检查 ,评价患者的肛门功能。结果　 2 6例患者肛管最大收缩压、收缩肌电振幅、持续收缩时间、直肠感觉阈值和感觉收缩时间治疗前、后均有显著差异 (P <0 .0 1)。结论　生物反馈治疗大便失禁有效     

Customized biofeedback therapy improves results in fecal incontinence

Background and aims Biofeedback therapy has been extensively used and accepted in fecal incontinence, but reports of its efficiency vary. We evaluated feedback therapy efficiency when (a) selecting the patients subject of the therapy, and (b) customizing the therapy protocol used for each patient.Patients and methods Fifty-three patients with fecal incontinence were selected for biofeedback training. The treatment program was customized for each patient depending on the underlying dysfunction, the patients cooperative and learning attitude, and the patients progress. Biofeedback efficiency was measured using clinical scores, subjective satisfaction of the patient, and manometry.Results Incontinent scores showed improvement in 66% of patients and good improvement in 11% and 15%, respectively, indicating an overall excellent effect of the therapy. Subjective satisfaction was strongly correlated with the previous incontinent scores. Comparison of manometry parameters before and after biofeedback therapy, including maximum anal resting, maximum anal squeeze pressure, and maximum duration of the squeeze, all showed significant differences. In addition, the sensory threshold significantly decreased after biofeedback therapy. Clinical improvements were maintained during the following 12 months.Conclusion Biofeedback improves objective and subjective parameters of anorectal function. Selection of patients and customization of the therapy program increased biofeedback efficiency for the treatment of fecal incontinence.     

Electromyographic assessment of biofeedback training for fecal incontinence and chronic constipation

INTRODUCTION: Biofeedback training is an effective modality for the treatment of chronic constipation and fecal incontinence. In general, patients express satisfaction and perceive functional improvement following biofeedback therapy; however, quantifying these observations has been difficult. AIM: This study was undertaken to evaluate the physiologic benefits of biofeedback therapy as reflected by noninvasive electromyography parameters. METHODS: Fifty-five patients who underwent computerized electromyography-based biofeedback treatment at our institution between July 1993 and July 1995 were identified. Noninvasive electromyographic testing was performed before, during (weekly), and at completion of training. Mean number of weekly sessions was seven (range, 5–11). Short-term and ten-second contractions (amplitude/V), sustained contractions (endurance, in seconds), and net strength (V) of the external anal sphincter before and after biofeedback were compared for differences. RESULTS: There were 30 patients with chronic constipation, mean age, 65.3 (range, 33–86) years, composed of 24 women, and 25 patients with fecal incontinence, mean age 66 (range, 34–85) years, composed of 12 males. Statistically significant improvement in endurance and net strength following biofeedback training was noted in both the constipated and the fecal incontinence groups. Fifty-three of 55 (96.4 percent) patients expressed 50 to 100 percent subjective satisfaction after biofeedback therapy. Forty-six of 55 (83.6 percent) patients demonstrated individually improved endurance. CONCLUSIONS: Sphincter endurance and net strength, as measured by noninvasive electromyography, significantly improve following biofeedback therapy in both constipated and fecal incontinence patients. These data suggest that endurance and net strength may be useful tools in assessing a benefit from biofeedback training in these patients.Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Seattle, Washington, June 9 to 14, 1996.     

Randomized trial of internal anal sphincter plication with pelvic floor repair for neuropathic fecal incontinence

PURPOSE: This study was designed to examine the role of adjuvant internal anal sphincter plication in women with neuropathic fecal incontinence undergoing pelvic floor repair. METHODS: We completed a randomized trial with symptomatic and physiologic assessment before and after surgery. RESULTS: There was no symptomatic advantage of adding internal sphincter plication; the mean improvement of functional score was 3.61±1.82 (standard deviation;P <0.01) following pelvic floor repair alone compared with 2.80±1.66 (standard deviation;P <0.01) when adjuvant internal anal sphincter plication was added. The addition of internal sphincter plication was associated with a significant fall in maximum anal resting and squeezing pressures (P <0.01). CONCLUSIONS: Addition of internal sphincter plication is not advised in women with neuropathic fecal incontinence treated by pelvic floor repair.     

Sensory retraining is key to biofeedback therapy for formed stool fecal incontinence

OBJECTIVES: Biofeedback is a nonsurgical treatment that reportedly produces good results in 65-75% of fecally incontinent patients. However, previous studies have not ruled out nonspecific treatment effects. It is also unknown whether biofeedback works primarily by improving the strength of the striated pelvic floor muscles or by improving the rectal perception. We aimed to 1) evaluate the efficacy of biofeedback in formed-stool fecal incontinence, 2) assess the relative contribution of sensory and strength retraining to biofeedback outcomes, and 3) identify patient characteristics that predict a good response to treatment. METHODS: Twenty-four patients with frequent (at least once a week) solid-stool incontinence were provided with three to four biofeedback sessions. They were taught to squeeze in response to progressively weaker rectal distentions. Patients were re-evaluated by anorectal manometry and symptom diary 3 months after completing training and by diary and interview 6-12 months after training. RESULTS: Seventeen (71%) were classified responders; 13 became continent and four reduced incontinence frequency by at least 75%. Clinical improvements were maintained at 12-month follow-up. At 3-month follow-up, responders had significantly lower thresholds for perception of rectal distention and for sphincter contraction, but squeeze pressures did not significantly differ from those of nonresponders. Baseline measures that predicted a favorable response were sensory threshold (50 ml or less), urge threshold (100 ml or less), lower threshold for sphincter contraction, and lower threshold for the rectoanal inhibitory reflex; neither anal squeeze pressure nor severity of incontinence predicted treatment outcome. CONCLUSIONS: In solid-stool fecal incontinence biofeedback training effects are robust and seem not to be explained by expectancy or nonspecific treatment effect. Sensory retraining appears to be more relevant than strength training to the success of biofeedback.     

Randomized trial of fecal diversion for sphincter repair

PURPOSE: Fecal diversion for sphincter repair is controversial. This randomized trial assessed whether fecal diversion would improve primary wound healing and functional outcome after sphincter repair. METHODS: Thirty-three patients with fecal incontinence requiring sphincter repair were recruited, but only 27 agreed to be randomly assigned to a defunctioning stoma (n=13) or no stoma (n=14). Patients were assessed by the Cleveland Clinic Incontinence Score (0–20) and anal physiology; the mean follow-up was 34 (range, 16–47) months. RESULTS: Incontinence score improved significantly in both groups (stoma, 13.5–7.8;P = 0.0072; no stoma, 14–9.6;P=0.0470): No difference was found between the two groups. Maximum resting pressure and maximum squeeze pressure increased significantly only in the no-stoma group (maximum resting pressure, 52.4–71.3 cm H₂O; maximum squeeze pressure, 87.3–100.7 cm H₂O;P<0.0001). There was no significant difference in functional outcome (stoma, 7.8; no stoma, 9.6;P=0.4567) or the number with complications of sphincter repair (stoma, 5; no stoma, 3;P=0.4197). However, stoma-related complications occurred in 7 of 13 patients having a stoma (parastomal hernia, 2; prolapsed stoma, 1; incisional hernia at the stoma site requiring repair, 5; and wound infection at the closure site, 1). CONCLUSION: Fecal diversion in sphincter repair is unnecessary, because it gives no benefit in terms of wound healing or functional outcome, and it is a source of morbidity.     

A randomized controlled trial of anorectal biofeedback for constipation

Purpose  

The purposes of this study were: (1) to examine the efficacy of anorectal biofeedback (AB) for constipation compared to a biofeedback control (BC) treatment and (2) to examine the extent to which self-reported childhood sexual/physical abuse predicted biofeedback outcome.     

Investigation of mode of action of biofeedback in treatment of fecal incontinence

A study was carried out in 25 incontinent patients to evaluate some of the factors thought to be responsible for the success of retraining for fecal incontinence. Subjects were initially allocated to one of two groups; one group was trained to perceive small rectal volumes (active retraining), the other group carried out the same maneuvers but were not given any information or instruction. Active sensory retraining reduced the sensory threshold from 32 +/- 8 to 7 +/- 2 ml (P less than 0.001), corrected any sensory delay that was present (P less than 0.004), and reduced the frequency of incontinence from 5 +/- 1 to 1 +/- 1 episodes per week (P less than 0.01). Sham retraining caused a modest reduction in the sensory threshold (from 29 +/- 9 to 20 +/- 8; P less than 0.05) but did not significantly reduce the frequency of incontinence. Subsequent strength and coordination training did not significantly improve continence, although at the end of the study, 50% of patients had no incontinent episodes at all and 76% of patients had reduced the frequency of incontinence episodes by more than 75%. This improvement in continence was not associated with any change in sphincter pressures or in the continence to rectally infused saline but was associated with significant improvements in rectal sensation. The functional improvement was sustained over a period of two years in 16 of the 22 patients available for follow-up. In conclusion, the results support the use of retraining in the management of fecal incontinence and suggest that retraining may work by enhancing rectal sensitivity and instilling confidence.     

Long-term outcomes of pelvic floor exercise and biofeedback treatment for patients with fecal incontinence

PURPOSE: The aim of this study was to assess the long-term clinical and quality of life outcomes for patients after referral to a four-month treatment program for fecal incontinence based on pelvic floor exercises and biofeedback. Secondary objectives were to document patients subsequent treatment activities and their perception of the biofeedback training; to establish the long-term outcomes and initial predictors for the subset of patients who did not complete the treatment, or who failed to improve during the program; and to correlate changes in clinical outcome measures and quality of life over time. METHODS: Patients were contacted by telephone to determine their perception of progress subsequent to the treatment program, any subsequent treatment or activities relating to their fecal incontinence, and which aspect of the treatment program they believed was most helpful. St. Marks and Pescatori fecal incontinence scores were also recorded, along with patients self-assessments of their incontinence severity and quality of life. RESULTS: Eighty-three (69 percent) patients were contacted for interviews at a median of 42 (range, 26–56) months after program completion. At the time of follow-up, patients who completed the program continued to enjoy strongly significant improvements in all outcome measures, with 75 percent perceiving a symptomatic improvement and 83 percent reporting improved quality of life. For many patients, improvement continued subsequent to program completion. Patients whose incontinence scores became worse during treatment still reported improvement in their quality of life and perceived incontinence severity during the same time period; many experienced some degree of catch-up in their continence scores during the follow-up period. Fourteen patients (17 percent) went on to have surgery for fecal incontinence; of these, 6 (7 percent) had a stoma. Twenty (24 percent) regularly took antidiarrheal medication. Thirty program completers (41 percent) were continuing pelvic floor exercises. CONCLUSIONS: This study confirms the long-term improvement in fecal incontinence achieved through treatment with biofeedback and pelvic floor exercises. In this study, patients also continued to improve after treatment completion, possibly because of the strong emphasis placed on patients during treatment to continue the pelvic floor exercises on their own. The poor correlation between quality of life and quantitative scores of fecal incontinence suggests that there are important aspects of continence that are not being appropriately recognized.     

Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review

Purpose

This systematic review determines the best known form of biofeedback (BF) and/or electrical stimulation (ES) for the treatment of fecal incontinence in adults and rates the quality of evidence using the Grades of Recommendation, Assessment, Development, and Evaluation. Attention is given to type, strength, and application mode of the current for ES and to safety.

Methods

Methods followed the Cochrane Handbook. Randomized controlled trials were included. Studies were searched in The Cochrane Library, MEDLINE, and EMBASE (registration number (PROSPERO): CRD42011001334).

Results

BF and/or ES were studied in 13 randomized parallel-group trials. In 12 trials, at least one therapy group received BF alone and/or in combination with ES, while ES alone was evaluated in seven trials. Three (four) trials were rated as of high (moderate) quality. Average current strength was reported in three of seven studies investigating ES; only two studies reached the therapeutic window. No trial showed superiority of control, or of BF alone or of ES alone when compared with BF + ES. Superiority of BF + ES over any monotherapy was demonstrated in several trials. Amplitude-modulated medium-frequency (AM-MF) stimulation, also termed pre-modulated interferential stimulation, combined with BF was superior to both low-frequency ES and BF alone, and 50 % of the patients were continent after 6 months of treatment. Effects increased with treatment duration. Safety reporting was bad, and there are safety issues with some forms of low-frequency ES.

Conclusions

There is sufficient evidence for the efficacy of BF plus ES combined in treating fecal incontinence. AM-MF plus BF seems to be the most effective and safe treatment.

Key Messages

? The higher the quality of the randomized trial the more likely was a significant difference between treatment groups. ? Two times more patients became continent when biofeedback was used instead of a control, such as pelvic floor exercises. ? Two times more patients became continent when biofeedback plus electrical stimulation was used instead of biofeedback only. ? Low-frequency electrical stimulation can have adverse device effects, and this is in contrast to amplitude-modulated medium-frequency electrical stimulation. ? There is high quality evidence that amplitude-modulated medium-frequency electrical stimulation plus electromyography biofeedback is the best second-line treatment for fecal incontinence.     

Can manometric parameters predict response to biofeedback therapy in fecal incontinence?

Read in part at the meeting of the New England Society of Colon and Rectal Surgeons, Bolton Landing, New York, October 1, 1994.