Randomized clinical trial comparing conservative and surgical treatment of neurogenic faecal incontinence. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Pilot study of two new injectable bulking agents for the treatment of faecal incontinence. A prospective randomized trial comparing four biofeedback techniques for patients with faecal incontinence. Double-blind crossover study of sacral nerve stimulation for fecal incontinence. Elastomer implants in faecal incontinence: a blind, randomized placebo-controlled study. Sacral root neuromodulation in the treatment of refractory urinary urge incontinence: a prospective randomized clinical trial. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group.
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. This randomized study was designed to compare the effect of sacral neuromodulation with optimal medical therapy in patients with severe fecal incontinence.
                Patients (aged 39-86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation (SNS group; n = 60) or best supportive therapy (control; n = 60), which consisted of pelvic floor exercises, bulking agent, and dietary manipulation. Full assessment included endoanal ultrasound, anorectal physiology, two-week bowel diary, and fecal incontinence quality of life index. The follow-up duration was 12 months.
                The sacral nerve stimulation group was similar to the control group with regard to gender (F:M = 11:1 vs. 14:1) and age (mean, 63.9 vs. 63 years). The incidence of a defect of < or = 120 degrees of the external anal sphincter and pudendal neuropathy was similar between the groups. Trial screening improved incontinent episodes by more than 50 percent in 54 patients (90 percent). Full-stage sacral nerve stimulation was performed in 53 of these 54 "successful" patients. There were no septic complications. With sacral nerve stimulation, mean incontinent episodes per week decreased from 9.5 to 3.1 (P < 0.0001) and mean incontinent days per week from 3.3 to 1 (P < 0.0001). Perfect continence was accomplished in 25 patients (47.2 percent). In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group.
                Sacral neuromodulation significantly improved the outcome in patients with severe fecal incontinence compared with the control group undergoing optimal medical therapy. The use of injectable bulking agents for passive faecal incontinence appears to provide reasonable short-term results. However experience with different agents is limited. We report on the outcome of injections with new bulking agents.
                Each patient received injections of either Bulkamid (hydrogel cross-linked with polyacrylamide) or Permacol (porcine dermal collagen). Assessment included clinical evaluation, anorectal physiological testing, endoanal ultrasonography and questionnaires including the St Mark's Incontinence Score, one week bowel diary card, the Faecal Incontinence Quality of Life Scale and the Short Form-36 (SF-36) health survey. Follow up was at 6 weeks and 6 months, with a further telephone review at a median of 19 months (range 14-22).
                Ten patients (nine female), median age 68 years (range 45-79), were enrolled. St Mark's incontinence score (0 = best, 24 = worst) was 15 (range 11-24) at baseline, 12.5 (range 3-18) at 6 weeks and 14 (range 6-22) at 6 months. A 1-week bowel diary and SF-36 forms also showed temporary improvement but this was not sustained beyond 6 weeks.
                Bulkamid and Permacol injections did not have a major effect on faecal incontinence. The aim of this study was to compare four methods of biofeedback therapy for patients with faecal incontinence (FI).
                All patients with FI who were ineligible for surgical management were prospectively randomized using a computer generated randomization method into one of four protocols: 1, out-patient intra-anal electromyographic biofeedback training (EMG); 2, EMG plus intrarectal balloon training (BT); 3, EMG plus a home trainer (HT); and 4, EMG, BT and HT. All patients received weekly, 1 h, out-patient biofeedback training. Success for patients with FI was measured by a reduction in incontinent episodes (days/week). In all instances, patients maintained a daily log in which documentation was recorded regarding each bowel evacuation.
                Forty patients were randomized into one of the four groups. Six patients withdrew after one session and were not included in the analysis. Therefore, 34 patients (23 female and 11 male) with a mean incontinence score of 12 (range 7-14) were randomized to one of the four groups (n=8, 8, 8, and 10, respectively). There was a statistically significant reduction in incontinent episodes for all groups. However, there were no significant differences in treatment outcome found in comparisons among the four groups.
                Biofeedback therapy significantly improves FI. Moreover, EMG training was as effective alone as was the addition of HT, BT or both for the treatment of FI. Patients with fecal incontinence not amenable to simple repair may have to undergo major reconstructive surgery or resort to a stoma. Sacral nerve stimulation is an alternative approach that may diminish incontinence by altering sphincter and rectal motor function. This study is the first double-blind trial examining the effectiveness of this therapy.
                Two patients with passive fecal incontinence who had been implanted for nine months with a permanent sacral nerve stimulator and electrode were studied using fecal incontinence diaries, anorectal physiological tests, and quality-of-life assessments (SF-36 health survey). The trial period consisted of two two-week periods, with the stimulator turned on for two weeks and off for two weeks. The main investigator and the patients were blinded to the status of the stimulator.
                There was a dramatic difference between the number and severity of episodes of incontinence when the stimulator was turned on vs. turned off (Patient 1, 20 vs. 2 episodes; Patient 2, 4 vs. 0 episodes; off vs. on). There was an increase in squeeze pressure (Patient 1, 70 vs. 100 cm H2O; Patient 2, 60 vs. 90 cm H2O; off vs. on), with moderate increases in resting pressure and rectal threshold and urge volumes. Quality-of-life measurements showed a marked improvement prestimulation vs. nine months after permanent stimulation.
                There is a marked, unequivocal improvement in symptoms of fecal incontinence with sacral nerve stimulation shown in this double-blind crossover trial. Sacral nerve stimulation improves the quality of life in selected patients with fecal incontinence. To test efficacy and safety of polydimethylsiloxane elastomer implants, a silicone biomaterial, in patients with severe faecal incontinence related to an impaired internal anal sphincter.
                Subjects were randomized to receive three injections of 2.5 mL of either physiological saline or polydimethylsiloxane elastomer. After local anaesthesia, an 18 gauge, 2.5-in needle was inserted through the perianal skin and laid down into the intersphincteric space. Treatment (saline or polydimethylsiloxane elastomer) was administered by means of a ratchet gun. Three injections of 2.5 mL each were performed in the area of the internal anal sphincter at 3, 7 and 11 o'clock positions. Main end point was the percentage of subjects in each treatment arm experiencing a successful treatment, defined as a Cleveland Clinic Florida-Faecal Incontinence score <8, 3 months after treatment. Secondary end points were quality of life scores, weekly number of faecal incontinence episodes, subject acceptance and adverse events rate. Both patients and end point assessments were blinded to treatment. Results: 44 women (64.3 +/- 9 years) with a baseline Cleveland Clinic Florida-Faecal Incontinence score > or =8 were enrolled prospectively; 22 received polydimethylsiloxane elastomer and 22 saline treatment. Treatment was well tolerated. At 3 months, the percentage of subjects experiencing a successful treatment was not different between polydimethylsiloxane elastomer and saline groups (23% vs. 27%, respectively, P = 0.73). Moreover, Cleveland Clinic Florida-Faecal Incontinence score was not significantly different between polydimethylsiloxane elastomer and saline groups (11.7 +/- 4.7 vs. 11.4 +/- 4.5, respectively, P = 0.79).
                Polydimethylsiloxane elastomer implants cannot be recommended for treatment of severe faecal incontinence related to impaired internal anal sphincter. To compare the effectiveness of sacral root neuromodulation with that of conservative management in ameliorating symptoms of refractory urinary urge incontinence and enhancing quality of life, to assess the objective response to neuromodulation as revealed by urodynamic testing, and to delineate the long-term outcomes of neuromodulation.
                Forty-four patients with refractory urge incontinence were randomized to undergo neuromodulation with an implantable impulse generator (n = 21) or to continue their prior conservative management (n = 23). At 6 months the control group was eligible for crossover to implant. Patient evaluation included voiding diaries, quality of life questionnaires, urodynamic testing, and documentation of adverse events. Long-term follow-up evaluations were conducted at 6-month intervals up to 36 months.
                At 6 months mean leakage episodes, leakage severity and pad usage in the implant group were significantly lower by 88% (p < 0.0005), 24% (p = 0.047) and 90% (p < 0.0005), respectively, than the corresponding control group mean values. Improvements in leakage episodes and pad usage of >/=90% were attained by 75 and 85% of the implant group, respectively, but none of the control group. One third of implant patients, but none of the control patients, achieved >/=50% improvement in leakage severity. Over half of the implant patients (56%) were completely dry compared with 1 control patient (4%). Implant patients, but not control patients, exhibited significant improvement with respect to two quality of life measures. Neuromodulation resulted in increases of 220% (p < 0.0005) and 39% (p = 0.013), respectively, in urodynamically assessed bladder volume at first contraction and maximum fill. At 36 months the actuarial rate of treatment failure was 32.4% (95% CI, 17.0-56.0%). Adverse events most frequently involved pain at the implant site, and the incidence of serious complications was low.
                Neuromodulation is markedly more effective than conservative management in alleviating symptoms of refractory urge incontinence. Quality of life and urodynamic function are also improved by neuromodulation. The effects of neuromodulation are long-lasting, and associated morbidity is low. This is the first double-blind multicenter study examining the effectiveness of sacral nerve stimulation in a significant number of fecally incontinent patients.
                A total of 34 consecutive patients (31 women), median age 57 years (range, 33-73 years), underwent sacral nerve stimulation for fecal incontinence. After implantation, 27 of 34 patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. While still blinded, the patients chose the period of stimulation (ON or OFF) that they had preferred. The mode of stimulation corresponding to the selected period was continued for 3 months (final period). Outcome measures were frequency of fecal incontinence and urgency episodes, delay in postponing defecation, score severity, feeling of improvement, preference for ON or OFF, quality of life, and manometric measurements.
                In the crossover portion of the study, the self-reported frequency of fecal incontinence episodes was significantly reduced during the ON versus the OFF period (P = 0.03), and this symptomatic improvement was consistent: 1) with the patients feeling of greater improvement during the ON versus OFF period (P = 0.02); 2) with the significant preference of patients (P = 0.02) for the ON versus OFF period. In the final period of the study, the frequency of fecal incontinence episodes decreased significantly (P = 0.005) in patients with the stimulator ON. The ability to postpone defecation (P = 0.01), the score for symptom severity (P = 0.0004), and the quality of life (P < 0.05) as well as anal sphincter function significantly improved.
                The significant improvement in FI during the ON versus OFF period indicated that the clinical benefit of sacral nerve stimulation was not due to placebo. A prospective, randomized study was performed to evaluate sacral nerve stimulation for the treatment of refractory urinary urge incontinence.
                Primary outcome variables were obtained from voiding diaries. After baseline evaluation candidates who satisfied inclusion criteria were enrolled into the study. Test stimulation results determined eligibility for randomization into a stimulation (treatment) or delay (control) group. The stimulation group included 34 patients who underwent implantation and were followed for 6 months. The delay group comprised 42 patients who received standard medical therapy for 6 months and then were offered implantation. The stimulation group completed a therapy evaluation test (on versus off) after 6 months.
                At 6 months the number of daily incontinence episodes, severity of episodes and absorbent pads or diapers replaced daily due to incontinence were significantly reduced in the stimulation compared to the delay group (all p<0.0001). Of the 34 stimulation group patients 16 (47%) were completely dry and an additional 10 (29%) demonstrated a greater than 50% reduction in incontinence episodes 6 months after implantation. Efficacy appeared to be sustained for 18 months. During the therapy evaluation test the group returned to baseline levels of incontinence when stimulation was inactivated. Urodynamic testing confirmed that sacral nerve stimulation did not adversely affect voiding function. Complications included implantable pulse generator site pain in 15.9% of the patients, implant site pain in 19.1% and lead migration in 7.0%. Surgical revision was required in 32.5% of patients with implants to resolve a complication. There were no reports of permanent injury or nerve damage.
                Sacral nerve stimulation is safe and effective in treating refractory urinary urge incontinence.
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.