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PubMed2000

A continence index predicts the early return of urinary continence after radical retropubic prostatectomy.

PURPOSE: We evaluated the ability of a newly developed continence index to predict the return of urinary continence 3 months after radical retropubic prostatectomy. MATERIALS AND METHODS: We developed and used a continence index to determine continence level after removal of the urinary catheter on postoperative day 15 in 145 men. A total of 20 patients were evaluated independently by 2 nurse specialists to assess continence index reliability. We evaluated continence level, pad use and degree of bothersomeness due to incontinence 3 months after catheter removal. The association of continence score with outcome variables was calculated using the Mantel-Haenszel trend test and the predictive ability of the continence score was determined by logistic regression to produce cumulative odds ratios. RESULTS: The intraclass correlation coefficient was 0.995 for the independently assessed continence index ratings and the Cronbach coefficient alpha was 0.65 for the 5 continence index parameters. Complete continence or continence with heavy activity but not always was achieved by 96%, 85% and 68% of the men in tertiles 1 (continence score 18), 2 (continence score 15 to 17) and 3 (continence score 14 or less), respectively. The cumulative odds ratio of 2.9 (95% confidence interval [CI] 1.9 to 4. 6) per tertile indicated a 2.9-fold increased chance of incontinence for each successively lower tertile. In addition, 96%, 82% and 68% of the men in tertiles 1 to 3, respectively, required no or 1 small pad daily. The cumulative odds ratio for pad use was 2.3 (95% CI 1.5 to 3.5) per tertile. Of the patients in tertiles 1 to 3 100%, 97% and 80%, respectively, had no or slight bothersomeness due to urinary incontinence. The cumulative odds ratio for bothersomeness level was 2.7 (95% CI 1.7 to 4.3) per tertile. The Mantel-Haenszel trend test showed a significant association of continence score with all 3 outcome variables (p < or =0.001). CONCLUSIONS: Our continence index is a simple and reliable instrument that provides useful prognostic information on the early return of continence after radical retropubic prostatectomy.

Adult↗
PubMed2000

[Treatment of female stress urinary incontinence with cystocele by Gore Tex colpofixation and Burch operation].

OBJECTIVE: We treat female urinary stress incontinence (USI) with cystocele with or without associated genital prolapse by a combination of sacral colpopexy and Burch anterior colposuspension. We evaluated the results of a consecutive series of 77 patients completing a telephone interview after a mean follow-up of 40.6 months (range: 15 to 74 months). MATERIAL AND METHODS: From January 1991 to December 1995, 77 patients (mean age: 56.7 years) underwent Gore-Tex sacral colpopexy and Burch colposuspension for USI. Levator ani myorrhaphy was also performed in 53 severe cases. Incontinence was severe in every case, and associated with stage > or = 2 cystocele in 93% of cases. Urodynamic assessment revealed detrusor instability (DI) in 17.3% of cases and sphincter insufficiency (SI) < or = 35 cm H2O in 11.9% of cases. The main complications were: 4 haemorrhages requiring transfusion of one unit, 2 wound abscesses, one wall haematoma, and one small bowel obstruction at the 4th month, treated surgically. RESULTS: Six patients were lost to follow-up (good early results) and 2 files could not be analysed with sufficient follow-up (patients died from other diseases). Good results were defined by at least two of the following criteria: patient satisfied, no incontinence and no need for protective pads. We obtained 59 successes (85.5%) and 10 failures (14.5%). The results remained stable over time with 88.8% of success after a follow-up of more than 60 months (20 patients). Nine of the 10 failures occurred during the first year. They were demonstrated by the survey, while the post-operative follow-up at one month had been satisfactory. No specific treatment was therefore proposed. The two main factors of failures were DI and severe SI. Three times more failures were observed when the preoperative closure pressure were less than 30 cm H2O. CONCLUSION: Sacral colpopexy combined with Burch operation is a reliable solution for repair of USI with marked cystocele. It ensures good initial results which persist at one year and in the long-term.

Adult↗
PubMed2006

Long-term effects of dextranomer endoscopic injections for treatment of urinary incontinence: an update of a prospective study of 31 patients.

PURPOSE: A prospective study was initiated 7 years previously to assess the efficacy of endoscopic dextranomer based implants for pediatric structural incontinence. Preliminary results revealed that at 3 years 50% of the patients were either dry or significantly improved. We report long-term results in the same cohort of patients. MATERIALS AND METHODS: A total of 33 children and adolescents 5 to 18 years old with severe incontinence due to sphincteric incompetence (exstrophy-epispadias complex in 13, neuropathic bladder in 16, bilateral ectopic ureter in 4) were enrolled. Of the patients 13 underwent 2 and 4 underwent 3 treatment sessions to achieve a definitive result. Mean injected volume was 3.9 ml (range 1.6 to 12) per session. At each evaluation patients were considered cured (dryness interval 4 hours), significantly improved (minimal incontinence requiring no more than 1 pad daily and no further treatment required) or treatment failures (no significant improvement). Videourodynamics were used to study the evolution of the bladder capacity, activity and compliance. A total of 31 patients were followed 3 to 7 years after the last injection. RESULTS: At 3 years after treatment 15 of 30 patients (50%) were dry or improved. One patient who had leakage after 3 years of dryness due to bladder deterioration subsequently underwent ileocystoplasty. At 4 years 12 of 25 patients (48%) were dry or improved. At 5 years 9 of 21 patients (43%) were dry, as were 4 of 11 (36%) at 6 years and 2 of 5 (40%) at 7 years of followup. The success rate according to pathological evaluation was comparable in neuropathic bladders (7 of 14, or 50%), exstrophy (3 of 6, or 50%) and epispadias (3 of 7, or 43%). Of 12 patients who underwent bladder neck plasty before the injection of bulking agent 7 (58%) were either dry or improved. The success rate was higher in males (13 of 23, or 57%) than in females (3 of 8, or 38%). Also, at puberty 2 males who were improved became dry. Bladder capacity increased in 12 of 18 initially small bladders and remained normal and stable in 9, while 4 initially dry patients had development of recurrent leakage secondary to bladder deterioration and underwent augmentation. Otherwise, there were no long-term side effects observed related to the injection of the bulking agent. CONCLUSIONS: Endoscopic treatment of severe organic urinary incontinence with dextranomer is durable for up to 7 years of followup in 40% of the patients.

Adolescent↗
PubMed2006

Urinary incontinence after radical prostatectomy: incidence by definition, risk factors and temporal trend in a large series with a long-term follow-up.

OBJECTIVES: To investigate the incidence of urinary incontinence and its development over time, to compare the effects of alternative definitions on the incontinence rate and to explore risk factors for incontinence after radical retropubic prostatectomy (RRP) for clinically localized prostate cancer. PATIENTS AND METHODS: Urinary continence was assessed using a questionnaire administered by a third party in 1144 consecutive patients after undergoing RRP at our department from January 1986 to December 2001. Overall, 985 men (86%) were suitable for evaluation (mean age 64.5 years, mean follow-up 95.5 months). We compared the effects of three definitions on the actuarial rate of continence: (1) no or occasional pad use; (2) 0 or 1 pads used daily, but for occasional dribbling only; (3) 0-1 pads daily. The time to recovery of continence was defined as the date on which the patient met the continence definitions. The impact of incontinence on health-related quality of life (HRQoL) was also evaluated. Univariate and multivariate analyses were used to identify predictors of incontinence, using data gathered prospectively. RESULTS: At the last follow-up at 24 months after RRP, 83%, 92.3% and 93.4% of men achieved continence according to definitions 1, 2 and 3, respectively. The difference in time to recovering continence was significant for definition 1 compared to the others (P < 0.001). Most men using 1 pad/day complained of occasional dribbling only (89.3%), considered themselves continent (98%) and their HRQoL was not as seriously affected as those requiring > or = 2 pads/day. Men continent (by definition 3) at 2 years had an actuarial probability of preserving continence of 72.2% at the last follow-up. On multivariate analysis the age at surgery (P = 0.009), anastomotic stricture and follow-up interval (both P < 0.001) were independent prognostic factors. Bilateral neurovascular bundle resection was another independent predictive factor (P = 0.03) in the subset of the last 560 men with available data on surgical technique. The reduction in the incidence of incontinence over time was as high as 86%. CONCLUSIONS: Continence improves progressively until 2 years from RRP but some patients can become incontinent later. The criterion of pad use discriminates well between men with a limited reduction in their QoL (no or one pad used) and those with a markedly affected QoL (> or =2 pads/day). It could be clinically valid to consider users of 1 pad/day as continent. Age, bilateral neurovascular bundle resection and anastomotic stricture are significant risk factors for incontinence. There was a marked trend for the incidence of incontinence and anastomotic stricture to decrease with time.

Adult↗
PubMed2005

Prevalence, management and impact of urinary incontinence in the workplace.

BACKGROUND: The few prior studies of urinary symptoms in the workplace have been small investigations of women in specific occupations (e.g. nursing) or industries (e.g. pottery manufacture). In this study, the aims were to describe the prevalence, management and impact of urinary incontinence for a large cross-section of employed women in the USA. METHODS: Five-page questionnaires were mailed to 5130 American households selected from the National Family Opinion survey panel during the spring of 2004. Usable questionnaires were returned by 3364 women in the target age range of 18-60 years. RESULTS: About 37% of the 2326 employed respondents reported urine loss during the last 30 days. The most common strategies for managing incontinence at work included frequent bathroom breaks and wearing pads. The use of urine control methods increased with the severity of urine loss. The effect of incontinence on workplace activities also increased with the severity of urine loss: 88% of employed women with the most severe symptoms reported at least some negative impact on concentration, performance of physical activities, self-confidence or the ability to complete tasks without interruption. CONCLUSION: Urinary incontinence is prevalent among employed women. Those who experience severe symptoms report that it has a negative effect on aspects of work. Programs on the prevalence and impact of urinary incontinence would help educate both employers and employees, and may lead to the development of better management techniques in the workplace.

Adolescent↗
PubMed2002

Absorbent products for containing urinary and/or fecal incontinence in adults.

OBJECTIVES: The objectives of this study were to assess the effectiveness and cost-effectiveness of different types of absorbent product for people with incontinence. DESIGN: A systematic review of randomized and quasi-randomized controlled trials was performed to compare different types of absorbent products for the containment of urinary and/or fecal incontinence in adults. SETTING AND METHODS: Randomized and quasi-randomized trials available by March 2000 were used. Trials were identified through searches of major bibliographic and research databases. Investigators in the field were also contacted to locate studies. SUBJECTS: The trials reviewed comprised a total of 345 participants. RESULTS: Five trials were identified. The following comparisons were considered: disposable versus nondisposable pad-and-pant systems or all-in-one diapers (bodyworns), disposable versus nondisposable underpads, bodyworns versus underpads, and superabsorbent versus fluff-pulp products. Outcomes and type of intervention were heterogeneous among trials. Combining data from more than one trial proved to be impracticable. In a single trial, fewer people who used disposable products complained of skin problems compared with those who used nondisposable products (odds ratio, 0.08; 95% confidence interval 0.03 to 0.20). Similarly, people who used superabsorbent products experienced less severe skin problems than those who used fluff pulp products (P <.03). CONCLUSIONS: The data were too few and of insufficient quality to provide a firm basis for practice. However, the data suggest that disposable products are more costly but more effective than nondisposable products in decreasing the incidence of skin problems and that superabsorbent products perform better than fluff pulp products.

Absorption↗
PubMed2003

The development of a questionnaire to measure the severity of symptoms and the quality of life before and after surgery for stress incontinence.

OBJECTIVES: To develop and validate a short questionnaire recording the severity of symptoms and the quality of life, pre- and post-operatively, in women undergoing surgery for stress incontinence. DESIGN: The questionnaire was designed from previously designed questionnaires and pilot studies. In this study, it was tested for validity and reliability using standard psychometric techniques. Data from the questionnaire are reported to a national database, which generates reports for comparison of surgical procedures, departments and surgeons. SETTING: Tertiary referral urogynaecology units at Baerum and Aker Hospitals, Norway, and 22 Norwegian departments of gynaecology. POPULATION: Fifty and 65 women with stress incontinence from Baerum and Aker hospitals, respectively, and 628 women with stress incontinence from 22 Norwegian departments of gynaecology. METHODS: Stress Incontinence, Urge Incontinence and Quality of Life Indices were constructed. Internal consistency of the indices was measured by Cronbach's alpha and test-retest reliability by Bland-Altman plots. Stress Incontinence Index was tested against stress test and Urge Incontinence Index and Stress Incontinence Index were tested against the 24-hour pad test. Quality of Life Index was tested against a part of the King's College Hospital Quality of Life Questionnaire. MAIN OUTCOME MEASURES: Face and content validity. Missing values of the questionnaire. Reliability and internal consistency. Criterion validity. RESULTS: The 628 women completed a mean of 98.2% of all the questions. The content validity was good. The reliability was good in terms of test-retest reliability and internal consistency. The criterion validity of stress and urge incontinence was tested against the stress and 24 hour pad tests. The correlation between the indices and the objective tests was moderate. The correlation between the Quality of Life Index and the physical and social part of the previously validated King's College Hospital questionnaire was good. CONCLUSIONS: The questionnaire is easy to understand and complete and is a valid and reliable instrument for assessment of the symptoms of incontinence and the quality of life. Pre- and post-operative evaluation of women with stress incontinence was performed in a standardised setting in 22 of the 37 Norwegian departments and the reporting to a national database was successful. Comparison of surgical procedures, departments and surgeons is possible.

Adult↗
PubMed2001

[Incidence and treatment of postprostatectomy urinary incontinence. Personal experience].

BACKGROUND: To evaluate frequency of postprostatectomy urinary incontinence in order to establish the last invasive and most efficacious treatment to completely restore urinary incontinence. METHODS: Between 1992 and 2000, twenty-four patients with retropubic postprostatectomy urinary incontinence were studied. The symptoms reported by all patients referred to lack of control of urine with consequent leakage upon activities exerting increased abdominal pressure (sneezing, lifting of heavy weights). These patients were submitted to urodynamic examinations and the degree of incontinence was further evaluated from the number of pads used daily (slight, 0-1; medium 2-3; severe, >3). Mean follow-up was three years, eight months. RESULTS: Of the twenty-four patients, twenty (83%) presented stress incontinence, two (8.5%) urge incontinence, and two (8.5%) a mixed type incontinence. Eighteen patients (36%) reported slight precocious incontinence which disappeared spontaneously within three-six months. Six patients (12%) reported total incontinence which had not improved within twelve months, in four of these patients, continence was achieved by means of perineal rehabilitation whilst in the remaining patients, use of pads (up to three pads/day) was necessary, due to failure of rehabilitation. CONCLUSIONS: Once the need has been established for radical anatomic prostatectomy which offers the possibility of postoperative continence, perineal rehabilitation represents the first choice treatment on account not only of the high percentage of successful results but also due to low invasiveness, whilst the use of the AMS 800 sphincter offers the only solution in those forms of severe incontinence refractory to less invasive forms of treatment.

Aged↗
PubMed1997

Therapeutic efficacy of clenbuterol for urinary incontinence after radical prostatectomy.

BACKGROUND: Urinary incontinence is one of the most common complications occurring after radical prostatectomy. We evaluated the efficacy of clenbuterol, a selective beta 2-adrenoceptor agonist, in the treatment of incontinence occurring after radical prostatectomy, using urodynamic assessment. METHODS: Fourteen men (mean age, 68 years) with post-radical-prostatectomy incontinence were treated with 20 mg of clenbuterol twice a day for 1 month. The urodynamic assessment was performed on all patients before and after the administration of clenbuterol. A pad scoring system was used to gauge the severity of incontinence before and after treatment. RESULTS: At 1 month after administration of clenbuterol, 9 of the 14 patients (64%) had dramatic improvement in pad scores. Treatment failed in 5 patients (36%) with severe incontinence. The results of urodynamic studies showed that the mean functional urethral length of the patients with post-radical-prostatectomy incontinence increased significantly after treatment. CONCLUSION: These results suggest that clenbuterol can be used as an effective agent for treating mild-to-moderate stress incontinence after radical prostatectomy.

Aged↗
PubMed2006

Long-term effects of dextranomer endoscopic injections for the treatment of urinary incontinence: an update of a prospective study of 61 patients.

PURPOSE: To treat sphincteric deficiency in children endoscopic bladder neck injections may avoid or salvage more complex procedures. A prospective study to assess the efficacy of bladder neck injections of dextranomer based implants (Deflux(R)) was done in a 7-year period in 61 patients. MATERIALS AND METHODS: From September 1997 to September 2004 we enrolled in the study 41 males and 20 females 5 to 18 years old with severe sphincteric incompetence, including exstrophy-epispadias in 26, neuropathic bladder in 27, bilateral ectopic ureters in 5, and miscellaneous in 3. Preoperative evaluation consisted of medical history, urine culture, urinary tract ultrasound and videourodynamics. This evaluation was repeated 6 months and 1 year after treatment, and yearly thereafter. Of the patients 17 underwent 2 and 4 underwent 3 treatment sessions to achieve a definitive result. At each evaluation the case was considered cured-a dryness interval of 4 hours between voids or CIC, significantly improved-minimal incontinence requiring no more than 1 pad daily and no further treatment required, and treatment failure-no significant, long lasting improvement. Videourodynamics were mainly useful to study the evolution of bladder capacity, activity and compliance. Followup after the last injection was 6 to 84 months (mean 28). RESULTS: Mean injected volume per session was 3.9 cc (range 1.6 to 12). Postoperative complications were temporary dysuria in 2 patients nonfebrile urinary tract infection in 10, orchid-epididymitis in 1 and urinary retention with pyelonephritis in 1. The incidence of dryness or improvement during followup was 79% (48 of 61 patients) at 1 month, 56% (31 of 55) at 6 months, 52% (24 of 46) at 1 year, 51% (18 of 35) at 2 years, 52% (16 of 31) at 3 years, 48% (12 of 25) at 4 years, 43% (9 of 21) at 5 years, 36% (4 of 11) at 6 years and 40% (2 of 5) at 7 years. The success rate according to pathological condition was similar in cases of neuropathic bladder and the exstrophy-epispadias complex (48% and 53%, respectively). The success rate in re-treated cases was 38%. After treatment a contracted bladder developed in 6 patients. Also, of the 35 patients with at least 2 years of followup an increase in capacity of at least 50% was observed in 12 of 18 with an initially small bladder. No side effects related to the substance were observed. CONCLUSIONS: Endoscopic treatment for pediatric severe sphincteric deficiency with dextranomer implant, a nontoxic, nonimmunogenic, nonmigratory synthetic substance, was effective up to 2 years in half of the patients. Subsequently at up to 7 years of followup a slow decrease in efficacy was observed and treatment remained beneficial in 40% of the patients.

Adolescent↗
PubMed2003

Comparison of outcomes after single or DOUBLE-CUFF artificial urinary sphincter insertion.

OBJECTIVES: To assess the effectiveness and complications associated with single and double-cuff artificial urinary sphincter (AUS) implantation for postprostatectomy stress urinary incontinence. METHODS: A retrospective study of 56 men with postprostatectomy stress urinary incontinence who underwent either single (28 patients) or double (28 patients) cuff AUS placement was performed. Patients in each cohort were matched on the basis of preoperative pad use, risk factors for complications, and age. Patient selection was blinded relative to outcome. Continence, quality of life, and complications were assessed using the Incontinence Impact Questionnaire Short Form (IIQ-7), postoperative pad use, and chart review. RESULTS: The mean age was 67 years for each group. Daily pad use decreased from 7.7 to 1.1 in patients treated with a single-cuff AUS and from 7.8 to 0.7 in patients with a double-cuff AUS (P = 0.25). Complete continence (0 pads daily) was reported in 3 (11%) of 28 men with single-cuff and 12 (43%) of 28 men with double-cuff sphincters (P = 0.008). The IIQ-7 scores improved from 14.8 to 3.1 after single-cuff placement and from 16.3 to 2.5 after double-cuff placement (P = 0.03). With an average follow-up of 41.3 and 21.2 months for the single and double-cuff cohorts, respectively, five complications were reported in the single-cuff recipients and four in the double-cuff patients. CONCLUSIONS: A significantly greater rate of complete continence and improvement in the IIQ-7 were seen in men with double-cuff AUS compared with single-cuff devices. Additional study is needed to confirm the relative advantages of double-cuff insertion.

Aged↗
PubMed1999

Results of pubovaginal sling for stress incontinence: a prospective comparison of 4 instruments for outcome analysis.

PURPOSE: Presently to our knowledge there are no standardized techniques to assess outcomes after surgery for stress incontinence. We performed a prospective blinded study to assess the correlation among physician and patient assessments, and a validated 24-hour pad test and voiding diary. MATERIALS AND METHODS: A total of 84 women were evaluated before and after pubovaginal sling for stress incontinence with a voiding diary, pad test and symptom questionnaire (patient assessment) administered by a blinded third party. The operating surgeon evaluated the patient using history, physical examination, pad test and voiding diary but was blinded to results of the outcome questionnaire. Preoperative focused neurourological examination and video urodynamics confirmed stress incontinence. Patients were assessed at least 1 year postoperatively. We compared patient assessment (cured, improved, failure) to the outcome of the pad test, voiding diary and physician assessment. The physician and questioner were blinded to each other. We considered patients with a pad test of 0 to 2 ml. as cured, 50% or more volume reduction as improved and less than 50% volume reduction as failure. Postoperative assessment did not differentiate between stress and urge incontinence. The kappa coefficient was used for statistical comparison. RESULTS: Average patient age was 58 years and average followup for the entire group was 4 years. Agreement among the 4 instruments to assess outcome was excellent (k >0.9) with respect to cured/improved versus failure but only good for cured versus improved versus failure (k >0.5). CONCLUSIONS: Outcomes following incontinence surgery may vary depending on how the analysis was performed, patient selection, definition of success and so forth. Our results indicate that a pad test and voiding diary are reliable and should be part of the normal followup after pubovaginal sling for sphincteric incontinence. When these tests are used in conjunction with defined parameters of success, there is excellent agreement with patient feelings in regard to success or failure of surgery. Nevertheless, these instruments and methods are imperfect at best.

Adult↗
PubMed2007

Are there differences between women with urge predominant and stress predominant mixed urinary incontinence?

OBJECTIVE: We sought to determine if there are differences in clinical and urodynamic parameters between women with urge predominant and those with stress predominant mixed urinary incontinence (MUI). METHODS: Charts of 99 female patients with complaints of MUI were reviewed. Patients were divided into two groups based on the subjective predominance of either stress incontinence (MSUI) or urge incontinence (MUUI). All patients completed a subjective evaluation including an AUA Symptom Index, Urogenital Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7). Objective non-invasive measures included physical exam, 48-hr voiding diary, and a 24-hr pad test. Videourodynamics studies (VUDS), performed in all patients, were reviewed and the presence and characteristics of detrusor overactivity (DO) and stress incontinence were noted. RESULTS: There were no significant differences between groups with respect to symptom scores. MUUI patients had significantly higher pad usage, and lower maximum and average voided volumes than MSUI patients. They were also more likely to have lower urodynamic bladder capacities and demonstrable DO (70% vs. 26%) on VUDS with contractions occurring at lower bladder volumes and with higher amplitude. MSUI patients were more likely to have demonstrable SUI on physical examination (63% vs. 16%) and on VUDS (100% vs. 61%). CONCLUSIONS: There do appear to be differences in clinical and urodynamic parameters between patients with stress predominant and urge predominant MUI. These may help to determine which component of the mixed incontinence is more problematic.

Aged↗
PubMed2004

Darifenacin, an M3 selective receptor antagonist, is an effective and well-tolerated once-daily treatment for overactive bladder.

OBJECTIVES: To evaluate the efficacy, tolerability and safety of darifenacin, a once-daily M3) selective receptor antagonist (M3 SRA), in patients with overactive bladder (OAB). METHODS: This multicentre, double-blind, placebo-controlled, parallel-group study enrolled 561 patients (19-88 years; 85% female) with OAB symptoms for >6 months, and included some patients with prior exposure to antimuscarinic agents. After washout and a 2-week placebo run-in, patients were randomised (1:4:2:3) to once-daily oral darifenacin controlled-release tablets (3.75 mg [n=53], 7.5 mg [229] or 15 mg [n=115]) or matching placebo (n=164) for 12 weeks. Patients recorded daily incontinence episodes, micturition frequency, bladder capacity (mean volume voided), frequency of urgency, severity of urgency, incontinence episodes resulting in change of clothing or pads and nocturnal awakenings due to OAB using an electronic diary during weeks 2, 6 and 12 (directly preceding clinic visits). Tolerability data were evaluated from adverse event reports. RESULTS: Darifenacin 7.5 mg and 15 mg had a rapid onset of effect, with significant improvement compared with placebo being seen for most parameters at the first clinic visit (week 2). This effect was sustained through week 12. At this time the number of incontinence episodes per week was reduced from baseline by 67.7% with darifenacin 7.5 mg and 72.8% with darifenacin 15 mg compared with 55.9% with placebo (p=0.010 and p=0.017, respectively, versus placebo). The 3.75 mg group (null dose arm) was included for proof of concept of dose flexibility, therefore formal sample sizing and statistical analysis were not performed for this group. Darifenacin 7.5 mg and 15 mg, respectively, were significantly superior to placebo for improvements in micturition frequency (p<0.001, p<0.001), bladder capacity (p<0.040, p<0.001), frequency of urgency (p<0.001, p=0.005), severity of urgency (p<0.001, p=0.002) and number of incontinence episodes leading to a change in clothing or pads (p<0.001, p=0.002). There was no significant reduction in nocturnal awakenings due to OAB. The most common adverse events were mild-to-moderate dry mouth and constipation. However, no patients withdrew from the study as a result of dry mouth and discontinuation related to constipation was rare (0.6% placebo versus 0.9% darifenacin). In addition, there was a low need for laxative use, with no difference between the darifenacin groups and those taking placebo. There were no reports of blurred vision and the CNS and cardiac safety profile was comparable to placebo. CONCLUSIONS: Darifenacin significantly improves the major symptoms of OAB. No significant CNS (primarily M1-receptor mediated) adverse events or cardiac (primarily M2-receptor mediated) adverse events were identified in this study, as may be predicted from the M3 selective receptor profile of darifenacin.

Adult↗
PubMed2003

Urethrolysis with Martius labial fat pad graft for iatrogenic bladder outlet obstruction.

This article evaluates treatment outcomes of urethrolysis with the Martius labial fat pad graft for patients with outlet obstruction after incontinence surgery. A total of 23 women were diagnosed with iatrogenic bladder outlet obstruction by urinary retention, urodynamic criteria, physical examination findings, and/or temporal relation of voiding dysfunction to anti-incontinence surgery. The urodynamic definition of female outlet obstruction was a maximum flow rate <12 mL/sec and a detrusor pressure at maximum flow >20 cm of water. Surgical treatment consisted of urethrolysis with complete circumferential urethral mobilization. A Martius labial fat pad graft was used to circumferentially wrap the urethra. No concurrent resuspension procedures were performed. Procedure efficacy was determined by retrospective review and phone interview. Mean patient age was 55 years (range, 37 to 85 years). Mean postoperative follow-up time was 15 months (maximum, 44 months). All patients related voiding dysfunction symptoms to their anti-incontinence surgery. In all, 17 of 23 (74%) patients had preoperative urinary retention requiring catheterization, and 63% of patients met urodynamic criteria for obstruction. After urethrolysis with a Martius labial fat pad graft, 20 of 23 (87%) patients had complete resolution of their obstruction; 3 patients required persistent catheterization. Postoperative stress incontinence was reported by 6 of 23 (13%) patients. Urodynamically documented detrusor instability occurred in 6 of 23 (26%) patients with de novo detrusor instability occurring in 3 of 15 (20%) patients.

Adipose Tissue↗
PubMed1998

Incidence of fecal and urinary incontinence following radical perineal and retropubic prostatectomy in a national population.

PURPOSE: Since 1991 we have performed more than 300 anatomical radical perineal prostatectomies at Brooke Army and Wilford Hall Medical Centers, and were initially aware of 8 patients who presented with unsolicited postoperative fecal incontinence. We determined the incidence of fecal and urinary incontinence following radical prostatectomy, defined parameters to identify patients at risk for fecal complaints following radical prostatectomy, and estimated the impact of fecal incontinence on lifestyle and activities. MATERIALS AND METHODS: Initially a validated 26-question telephone survey was used to evaluate 227 patients who had previously undergone radical prostatectomy at 1 of our 2 institutions. Based on results of the telephone survey a national survey was mailed to 1,200 radical prostatectomy patients randomly selected from a nationwide database of Department of Defense health care system beneficiaries. All patients had undergone radical perineal or retropubic prostatectomy at least 12 months before being contacted for the survey. RESULTS: Responses to the telephone survey from 227 patients revealed that fecal incontinence was a problem after radical retropubic (5%) and perineal (18%) prostatectomy and less than 50% of those with fecal incontinence had told the physician. Our mail survey (response rate 80% and 78% usable for analysis, 784 radical perineal and 123 perineal) strongly indicated that fecal incontinence after radical prostatectomy is a problem nationwide. Frequency of fecal incontinence (daily, weekly, monthly or less than monthly occurrences) was significantly higher among radical perineal (3, 9, 3 and 16%) compared to retropubic prostatectomy (2, 5, 3, and 8%) patients (p=0.002). Fecal incontinence had a significant negative effect on patient social or entertainment activities (p=0.029), and travel and vacation plans (p=0.043). Radical perineal compared to retropubic prostatectomy patients were more likely to wear a pad for stool leakage (p=0.013), experienced more accidents (p=0.001), had larger amounts of stool leakage (p=0.002) and had less formed stools (p=0.001). Of radical perineal prostatectomy patients only 14% and of retropubic only 7% with fecal incontinence had ever told a health care provider about it, even when the incontinence was severe. Responses to our survey concerning urinary incontinence showed that radical perineal prostatectomy patients had a lower rate of urinary incontinence immediately after prostatectomy compared to retropubic (79 versus 85%, p=0.043). A higher proportion of perineal patients reported that all urinary leakage had ceased, that is full continence had returned (perineal 70%, retropubic 53%, p=0.001). A smaller proportion of perineal patients found it necessary to wear a pad to protect from urinary incontinence (perineal 39%, retropubic 56%, p=0.004). CONCLUSIONS: Fecal incontinence following radical prostatectomy occurs more frequently than previously recognized. In general fecal incontinence among radical perineal and retropubic prostatectomy patients surpasses the expected incidence rate of 4% for this age group (60 to 70 years) but incidence is significantly higher for radical perineal prostatectomy patients. However, radical perineal prostatectomy patients have a significantly lower incidence of urinary incontinence than those treated with retropubic prostatectomy. Surgeons who perform radical retropubic and perineal prostatectomy should be aware of the possibility of fecal and/or urinary incontinence and associated symptoms.

Activities of Daily Living↗
PubMed1994

Biofeedback treatment of bladder dysfunction in multiple sclerosis. A randomized trial.

Fifteen women and five men with bladder dysfunction due to multiple sclerosis were randomized to plus/minus biofeedback using bladder pressure and simultaneous EMG registration via surface electrodes. All the patients had behavioural modification, pharmacological adjustment and pelvis floor training. The number of incontinence episodes decreased and maximal cystometric capacity increased, while first sensation and pad test were unchanged. Subjective treatment results assessed by visual analogue scales for incontinence and obstrusive voiding symptoms were highly significant. However no biofeedback parameter was improved and no difference could be demonstrated between the two treatment groups. In conclusion the used biofeedback technique is insufficient and the 60 min. standardized pad weighing test is inadequate in this type of patients.

Adult↗
PubMed1998

Incidence and subsequent impact of pelvic abscess after ileal pouch-anal anastomosis for chronic ulcerative colitis.

PURPOSE: This study was designed to measure the impact of pelvic abscess on eventual pouch failure and functional outcome after ileal pouch-anal anastomosis in patients with chronic ulcerative colitis. PATIENTS AND METHODS: The outcome of 1,508 patients who underwent ileal pouch-anal anastomosis for chronic ulcerative colitis at the Mayo Clinic was determined from a central patient registry, data were collected prospectively. RESULTS: Seventy-three patients developed a pelvic abscess as a complication of ileal pouch-anal anastomosis. Pouch failure occurred in 19 (26 percent). Forty-eight patients (55 percent) required transabdominal salvage surgery, 6 (8 percent) underwent local surgery, and the remaining 27 (37 percent) were treated nonsurgically. Wound infection was more common in patients who experienced pelvic abscess. The majority of pouch failures secondary to pelvic abscess formation occurred within two years of ileal pouch-anal anastomosis. Daytime incontinence, the use of a protective pad, and the need for constipating or bulking medication were significantly more common among patients who had an abscess but kept their reservoir. Ability to perform work and domestic activities and to undertake recreational activities were significantly more restricted among these patients. CONCLUSIONS: Pouch failure occurs in one-fourth of patients who retain their pouch despite pelvic abscess after ileal pouch-anal anasto mosis. Among patients who retain their pouch despite postoperative pelvic abscess, functional outcome and quality of life are significantly poorer than in patients in whom no sepsis occurred.

Abscess↗