The comparison of artificial urinary sphincter implantation and endourethral macroplastique injection for the treatment of postprostatectomy incontinence. Fecal incontinence: the quality of reported randomized, controlled trials in the last ten years. A randomised controlled trial: outcomes of bladder rehabilitation in persons with multiple sclerosis. A prospective randomized trial comparing four biofeedback techniques for patients with faecal incontinence. Combined behavioral and individualized drug therapy versus individualized drug therapy alone for urge urinary incontinence in women. Biofeedback for fecal incontinence: a randomized study comparing exercise regimens. Stress incontinence surgery for patients presenting with mixed incontinence and a normal cystometrogram. Sacral root neuromodulation in the treatment of refractory urinary urge incontinence: a prospective randomized clinical trial. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group.
To compare the effectiveness of macroplastique injection with artificial urinary sphincter implantation (AUS) for treatment of postprostatectomy incontinence (PPI).
                A prospective randomized clinical trial including 45 patients with PPI was performed secondary to radical retropubic prostatectomy (RRP), transvesical prostatectomy (TVP), transurethral prostatectomy (TURP), and TURP with TVP, in 12, 16, 16, 1 patients respectively. Patients were divided into two groups as minimal (group I) and total incontinence (group II) according to the severity of incontinence. Respectively, Group I (n = 21) and group II (n = 24) patients were randomized as AUS implantation (n = 11, n = 11) and macroplastique injection (n = 10, n = 13). Follow-up period was 48 (6-84) months in patients with macroplastique injection and 60 (8-120) months in AUS implantation. The success of the treatment was evaluated by calculating the average number of pads used by the patient per day, the weight of the pads and score of quality of life survey scale for each group both in the preoperative and in the postoperative period.
                There were statistically significant differences between preoperative and postoperative average pad weight, average number of pads and quality of life scores, both in patients with minimal and total incontinence. In group I there was no statistically significant difference between the two techniques. However, in group II there was a significant difference favoring AUS implantation.
                Endourethral injection should be the treatment of choice for patients with minimal incontinence, whereas AUS implantation as the first choice for patients with total incontinence. This study was designed to analyze the characteristics and the quality of reporting of randomized, controlled trials published during the last ten years on fecal incontinence.
                An electronic search for all randomized, controlled trials on fecal incontinence was undertaken by using the MEDLINE database via PubMed. The data collected were divided into general data, characteristics of reporting, methodology quality assessment using the Jadad scale and a validated methodology quality score (MINCIR score), evaluation of the items published in the CONSORT statement, and the journal impact factor. Reports were divided into two groups: published articles from 1996 to 2000 (Group 1), and from 2001 to 2005 (Group 2).
                Forty-two trials fulfilled the inclusion criteria of the study (Group 1, n = 15; and Group 2, n = 27). There were no significant differences in general characteristics of randomized, controlled trials between the two groups. In Group 2, there were a statistically significant higher number of studies that reported a flow chart (P < 0.001), written informed consent (P = 0.008), sample size calculation (P = 0.023), and withdrawals and dropouts (P < 0.001). We found a statistically significant higher score in Jadad scale (P = 0.046) and MINCIR score (P = 0.016) in the published studies in Group 2. Also we found higher journal impact factor of journals that published these randomized, controlled trials during the most recent years (P = 0.04).
                There is a lack of high-quality reported randomized, controlled trials on fecal incontinence during the last ten years. Reports of randomized, controlled trials involving patients with fecal incontinence published after 2001 were better reported than in the previous five years. A stratified, randomised, waitlist controlled study over 12 months assessed the effectiveness of a 6 week bladder rehabilitation programme in persons with multiple sclerosis (pwMS) in an Australian community cohort.
                Patients with definite MS and bladder issues (n=74) recruited from a tertiary hospital database were randomised to a treatment group (n=40) for an individualised bladder rehabilitation programme or to a control waitlist group (n=34). The Urogenital Distress Inventory (UDI6), Neurological Disability Scale (NDS) and the American Urological Association Symptom Index (AUA) assessed bladder impairment and 'activity limitation'; a single Quality of life (QoL) item in the AUA and the Incontinence Impact Questionnaire (IIQ7) measured restriction in 'participation'. Primary outcome measures were assessed at baseline and at 12 months.
                Analysis of per protocol data from 58 patients (treatment n=24, control n=34) showed reduced disability in the treatment group, with significant differences (p<0.001) and large effect sizes (>0.5) in post-treatment UDI6, NDS, AUA total, AUA QoL and IIQ7 scores for the two groups. The treatment group compared with the control group showed improvement: 78% versus 27% for UDI6 and 59% versus 17% improved for IIQ7. More patients in the control group deteriorated over the study period on the UDI6 (30% vs 0%; p<0.001) and IIQ7 (39 vs 0%; p=0.001).
                A multifaceted, individualised bladder rehabilitation programme reduces disability and improves QoL in pwMS compared with no intervention after 12 months of follow-up. Information on specific interventions in different bladder types in MS and the impact on QoL need further evaluation. Australian Clinical trials Registry ACTRNO12605000676617. 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. We tested whether individualized drug therapy enhanced with behavioral training would result in better outcomes than individualized drug therapy alone.
                Participants were community dwelling women with urge predominant incontinence. Using a randomized clinical trial design women were randomized to 8 weeks (4 visits) of drug therapy alone (32) or drug therapy plus behavioral training (32). Drug therapy was individually titrated, extended release oxybutynin with proactive management of side effects. Behavioral training included pelvic floor muscle training and urge suppression techniques. The primary outcome measure was reduction in frequency of incontinence episodes on bladder diary at 8 weeks (with followup at 6 and 12 months). Secondary outcomes included patient satisfaction, global perception of improvement, Urogenital Distress Inventory and Incontinence Impact Questionnaire.
                In intent to treat analysis frequency of incontinence was reduced a mean of 88.5% in the drug alone group and 78.3% in the combined therapy group (p = 0.16). Outcomes were not significantly different between the groups in the analysis of completers (91.5% vs 86.2%, p = 0.34), or in either analysis at 6 or 12 months. The groups also did not differ significantly on secondary outcomes at any point. Participants in the drug alone group tended to be taking higher doses of oxybutynin at 8 weeks but the final dose did not differ significantly between the groups. Based on a conditional power calculation the trial was stopped early for futility.
                When drug therapy is implemented with frequent individualized dose titration, daily bladder diaries and careful management of side effects, initiating concurrent behavioral training does not enhance outcomes for urge incontinence in women.
                Copyright (c) 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved. Fecal incontinence affects up to 11% of Australian community-dwelling adults and 72% of nursing home residents. Biofeedback is a recommended conservative therapy when medication and pelvic floor exercises have failed to improve patient outcomes.
                This study aimed to investigate the impact of a new exercise regimen on the severity of fecal incontinence and the quality of life of participants.
                This was a randomized clinical study.
                This study was conducted at the Anorectal Physiology Clinic, Townsville Hospital, Queensland, Australia.
                Seventy-two participants (19 male), with a mean age of 62.1 years, attended 5 clinic sessions: 4 weekly sessions followed by 4 weeks of home practice and a follow-up assessment session. A postal survey was conducted 2 years later.
                Thirty-seven patients (12 male) were randomly assigned to the standard clinical protocol (sustained submaximal anal and pelvic floor exercises) and 35 patients (7 male) were randomly assigned to the alternative group (rapid squeeze plus sustained submaximal exercises).
                The main outcomes were measured by use of the Cleveland Clinic Florida Fecal Incontinence score and the Fecal Incontinence Quality of Life Scale survey tool.
                No significant differences were found between the 2 exercise groups at the beginning or at the end of the study or as a result of treatment in objective, quality-of-life, or fecal incontinence severity measures. Sixty-nine participants completed treatment. The severity of fecal incontinence decreased significantly (11.5/20 to 5.0/20, P < .001). Eighty-six percent (59/69) of participants reported improved continence. Quality of life significantly improved for all participants (P < .001). Results were sustained 2 years later. Patients who practiced at least the prescribed number of exercises had better outcomes than those who practiced fewer exercises.
                This study was limited because it involved a heterogeneous sample, it was based on subjective reporting of exercise performance, and loss to follow-up occurred because of the highly mobile population.
                Patients attending this biofeedback program attained significant improvement in the severity of their fecal incontinence and in their quality of life. Although introduction of rapid muscle squeezes had little impact on fecal incontinence severity or patient quality of life, patient exercise compliance at prescribed or greater levels did. To evaluate the outcome of surgery for stress urinary incontinence (SUI) in patients presenting with a combination of stress and sensory urge UI.
                The study comprised 75 women presenting with mixed incontinence; the most important inclusion criterion was a negative cystometrogram for detrusor overactivity. Based on random selection, a third of the patients received a 6-month course of anticholinergic treatment (group 1) and 50 (group 2) had surgery for SUI. The surgical procedure depended on the Valsalva leak-point pressure (VLPP); those with a VLPP of > or = 90 cmH2O underwent Burch retropubic bladder neck suspension (group 2a, 24 patients) while 26 (group 2b) with a VLPP of < 90 cmH2O had pubovaginal sling (PVS) surgery. A further group of 20 patients with pure SUI (no urge UI) underwent surgery (PVS in 12 and Burch in eight) as a control group (group 3). After at least 6 months of follow-up (mean 9.3, sd 1.7), 68 patients were evaluable; they were assessed subjectively and objectively for dryness, and by a urodynamic evaluation and quantitative assessment using the SEAPI scoring system.
                In group 1 none of the patients became completely dry; there was persistent stress with and without urge UI in nine (43%) and 12 (57%) of the available 21 patients, respectively. Only three of those who had persistent SUI with no urge in the whole study group were satisfied and chose to continue anticholinergic therapy despite SUI. In this group the mean (sd) improvement in the subjective and objective SEAPI score was 3.4 (1.0) and 2.3 (3.8), respectively. In group 2a, 20 of the available 23 patients (87%) became completely dry (both stress and urge continent). The mean improvement in the SEAPI scores was 7.8 (0.9) and 7.8 (1.3), respectively. In group 2b, 20 of the 24 patients (83%) became completely dry, with mean improvements in SEAPI scores of 8.2 (0.4) and 7.9 (0.3), respectively. The improvement was statistically significant after surgery, vs anticholinergic therapy, for all variables (P < 0.05). The incidence of persistent urge UI was highest in group 1 (43%), being 13% in group 2 (13% and 12% in 2a and b, respectively). In group 3 there was de novo urge UI in four of the 20 patients, and not significantly different from that in group 2.
                Most patients with mixed stress and urge UI and a normal cystometrogram were cured of both symptoms by surgery. The incidence of residual urge in such patients was no higher than that of de novo urge after surgery in patients with genuine SUI. 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. 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 evidence available at present is limited because only one small randomised clinical trial was identified. Although the result is favourable for the implantation of AUS in the group with severe incontinence, this result should be considered with caution due to the small sample size and uncertain methodological quality of the study found.