A pilot study of total pelvic floor repair or gluteus maximus transposition for postobstetric neuropathic fecal incontinence. Pelvic floor procedures produce no consistent changes in anatomy or physiology. Randomized trial of internal anal sphincter plication with pelvic floor repair for neuropathic fecal incontinence. Adjuvant biofeedback following anal sphincter repair: a randomized study. A prospective, randomized, controlled clinical trial of placement of the artificial bowel sphincter (Acticon Neosphincter) for the control of fecal incontinence. Randomized clinical trial comparing conservative and surgical treatment of neurogenic faecal incontinence. Randomized trial comparing three forms of pelvic floor repair for neuropathic faecal incontinence. Direct repair vs. overlapping sphincter repair: a randomized, controlled trial.
The aim of this study was to report pilot data comparing the morbidity and functional outcome of total pelvic floor repair with gluteus maximus transposition for women with postobstetric fecal incontinence.
                This is a prospective, randomized trial of two surgical procedures in 24 women so far. Functional assessment was performed with use of a 20-point clinical incontinence score and patient questionnaire before and after operation. The physiologic parameters, before and after operation, included resting and squeeze anal pressures, length of the high pressure zone, anal and rectal mucosal sensitivity, and pudendal nerve latency.
                So far, 12 patients have been treated by total pelvic floor repair and 12 by gluteus maximus transposition. Of these, three patients developed wound complications after gluteus maximus transposition compared with none after total pelvic floor repair. Among these cases there was a significant overall improvement in functional score (given as mean +/- standard deviation) after both total pelvic floor repair (13.1 +/- 2.7 vs. 6.6 +/- 4.5; P < 0.001) and gluteus maximus transposition (13.8 +/- 3.8 vs. 7.7 +/- 6.1; P < 0.01), although no difference existed between the groups. There was no change in any of the physiologic measurements after either operation, and preoperative measurements did not identify patients likely to do badly.
                We conclude from these preliminary data that both total pelvic floor repair and gluteus maximus transposition significantly improve continence in women with postobstetric neuropathic fecal incontinence. Gluteus maximus transposition gives equivalent results to total pelvic floor repair. Neither procedure has any influence on anorectal physiologic parameters. Postanal repair was designed to restore both anatomy and function of the anal canal in neurogenic fecal incontinence. In most series, the degree of continence is improved in fewer than 50 percent of patients. Adding anterior levatorplasty and sphincter plication (total pelvic floor repair) is claimed to improve functional results. We performed a randomized trial comparing postanal and total pelvic floor repair for neurogenic incontinence.
                Twenty female patients were studied. All had Type D incontinence (Parks and Browning). Anal manometry, defecography, and grading of the degree of continence were repeated 12 weeks after surgery to assess changes in clinical, manometric, and radiologic parameters. Statistical analysis was done using Wilcoxon's signed-rank test and Wilcoxon's two-sample test.
                Continence improved in eight patients. Differences among clinical, manometric, and radiologic data were not statistically significant.
                Pelvic floor repair procedures produce no consistent changes in anatomy or physiology. Clinical improvement is caused by creation of a local stenosis or by the placebo effect rather than by improvement of muscle function. This study was designed to examine the role of adjuvant internal anal sphincter plication in women with neuropathic fecal incontinence undergoing pelvic floor repair.
                We completed a randomized trial with symptomatic and physiologic assessment before and after surgery.
                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 and 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).
                Addition of internal sphincter plication is not advised in women with neuropathic fecal incontinence treated by pelvic floor repair. To evaluate the impact of adjuvant biofeedback following sphincter surgery.
                Thirty-eight patients were randomized into sphincter repair or sphincter repair plus biofeedback groups. Outcome measures included a symptom questionnaire, patient's rating of satisfaction with continence function and improvement, change in continence score, quality of life and anorectal physiology. Endoanal ultrasonography was also performed pre- and post-operatively.
                Immediately following surgery, there was no statistically significant difference in any of the functional or physiological variables between the groups. Continence and patient satisfaction scores improved with a mean difference of -0.48 (95% CI: -3.30-2.33, P = 0.73) and 1.03 (95% CI: -1.40-3.46, P = 0.39), respectively. Only the difference in embarrassment scores reached statistical significance (mean) 0.56 (95% CI: 0.12-0.99, P = 0.014). Resting and squeeze pressures also improved. Thirteen of 14 in the biofeedback and 11 of 17 (control) reported symptomatic improvement. In the biofeedback group, although not statistically significant continence and satisfaction scores improved and were sustained over time. In the control group, continence and satisfaction scores changed little between 3 and 12 months (P = NS). Quality of life measures improved within the biofeedback group but there was no statistical difference between the groups.
                Following surgery continence function improves in all patients but adjuvant biofeedback therapy improves quality of life and maintains symptomatic improvement over time.
                Copyright 2004 Blackwell Publishing Ltd Severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician. A series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life. We have performed a prospective, randomized, controlled trial to evaluate the effect of placement of an artificial bowel sphincter (Acticon Neosphincter) on continence and quality of life in a group of severely incontinent adults.
                Fourteen adults (male:female, 1:13; age range, 44-75 years) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study. The principal outcome measure was the level of continence, measured with the Cleveland Continence Score, which provides a scale from 0 to 20, representing perfect control through to total incontinence. Secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group, and the changes in quality of life in both groups.
                In the control group, the Cleveland Continence Score was not significantly altered, with an initial value of 17.1 +/- 2.3 and a final value of 14.3 +/- 4.6 at six months. The artificial bowel sphincter group showed a highly significant improvement, changing from 19.0 +/- 1.2 before placement to 4.8 +/- 4.0 at six months after placement. One patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device (14 percent explantation rate). There were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another. There were major improvements in the quality of life for all measures in the artificial bowel sphincter group. There was significant improvement in all eight subscales of the Medical Outcome Study Short Form-36 measures. The American Medical Systems Quality of Life score was raised from 39 +/- 6 to 83 +/- 14 and the Beck Depression Inventory showed reduction from a level of mild depression (10.8 +/- 9.3) to a normal value (6.8 +/- 8.7). No significant changes in any of the quality of life measures occurred for the control group.
                Through a prospective, randomized trial format, we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone. Perioperative and late problems are likely to continue to occur and between 15 percent and 30 percent of patients may require permanent explantation. For the remainder, the device is easy and discrete to use, highly effective in achieving continence, and able to generate a major improvement in the quality of life. The treatment of choice in idiopathic (neurogenic) faecal incontinence is controversial. In a randomized study levatorplasty was compared with anal plug electrostimulation of the pelvic floor with respect to functional outcome and physiological variables.
                Thirty-one patients underwent levatorplasty and 28 anal plug electrostimulation of the pelvic floor over 3 years. The results were evaluated at 3, 12 and 24 months after completion of treatment by means of a validated questionnaire and anorectal manometry and manovolumetry.
                Incontinence scores were significantly reduced during the entire observation period in both groups (P < 0.001) as was the use of pads (P = 0.003 to P < 0.001). The proportion of patients reporting improvement in physical and social handicap was greater in the levatorplasty group after 3, 12 and 24 months (P = 0.036 to P < 0.001). No significant changes in physiological variables were observed in either group.
                Better results were obtained with levatorplasty than with anal plug electrostimulation of the pelvic floor in patients with idiopathic (neurogenic) faecal incontinence. Levatorplasty should be therefore be considered the treatment of choice for this condition.
                Copyright 2004 British Journal of Surgery Society Ltd. A randomized controlled trial in women with neuropathic faecal incontinence compared total pelvic floor repair (n = 12) with anterior levatorplasty and sphincter plication alone (n = 12) and postanal repair alone (n = 12). Review at 6 and 24 months indicated that results were significantly better for total pelvic floor repair than either of the other procedures. Complete continence was achieved in eight of the 12 patients 2 years after total pelvic floor repair. Only total repair significantly elongated the anal canal. Both total pelvic floor repair and anterior levatorplasty improved sensation in the upper anal canal. The aim of this study was to compare the results of two surgical techniques (direct end-to-end vs. overlapping) of delayed repair of a localized anterior defect of external anal sphincter after an obstetric trauma.
                During a five-year period, 23 patients were randomly assigned to direct end-to-end repair (n = 12) or overlapping sphincter repair (n = 11), using 2-0 PDS sutures. Two patients from each group had an internal anal sphincter defect that also was repaired. All patients had a normal pudendal nerve terminal motor latency preoperatively. Evaluations included endoanal ultrasound, anorectal manometry, and neurophysiologic evaluation. Continence was assessed by the Cleveland Clinic Continence Score (0-20; 0, perfect continence; 20, complete incontinence).
                The two groups were comparable with regard to age (median, 45 years), past history of sphincter repair (n = 2), and posterior vaginal repair. There was no major morbidity. The wound-healing rate was identical between the two groups. However, of the patients undergoing overlapping repair, two had fecal impaction, and one had a urinary retention. Median preoperative continence score was 17 in both the direct-repair group (score, 8-20) and the overlap group (score, 7-20). At a median follow-up of 18 months, the improvement in continence was similar between the two surgical groups, with a median continence score of 3, respectively. In both surgical groups there was a significant and similar improvement in maximum squeeze pressure and in the functional anal canal length postoperatively (P < 0.05), but the mean resting pressure was relatively unchanged. In the overlap group, one patient developed a unilaterally prolonged pudendal nerve terminal motor latency that was persistent 22 months after surgery, and two patients had impaired fecal evacuation postoperatively.
                This randomized, controlled study suggests that the outcome is similar whether direct end-to-end or overlapping repair of a sphincter defect is performed. Overlapping repair might be associated with more difficulties with fecal evacuation and a prolonged pudendal nerve terminal motor latency postoperatively.
The review is striking for the lack of high quality randomised controlled trials on faecal incontinence surgery that have been carried out in the last 10 years. Those trials that have been carried out have focused on sacral neuromodulation and injectable bulking agents, both reported in separate reviews. The continued small number of relevant trials identified together with their small sample sizes and other methodological weaknesses limit the usefulness of this review for guiding practice. It was impossible to identify or refute clinically important differences between the alternative surgical procedures. Larger rigorous trials are still needed. However, it should be recognised that the optimal treatment regime may be a complex combination of various surgical and non-surgical therapies.