The Michigan Incontinence Symptom Index (M-ISI): a clinical measure for type, severity, and bother related to urinary incontinence.

AIMS: To develop a clinically relevant, easy to use, and validated instrument for assessing severity and bother related to urinary incontinence. METHODS: Survey items were piloted and refined following psychometric principles in five separate patient cohorts. Patient and expert endorsement of items, factor analyses, Spearman rank correlations and response distributions were employed for item selection. Formal reliability and validity evaluation were conducted for the final questionnaire items. RESULTS: Expert physicians and patient focus groups confirmed face and content validity for the measure. A 10-item measure called the Michigan Incontinence Symptom Index (M-ISI) was developed with two domains: a Total M-ISI Domain consisting of subdomains for stress urinary incontinence, urgency urinary incontinence, and pad use, and a Bother Domain. High construct validity was demonstrated with a Cronbach's alpha for the Total M-ISI Domain (items 1-8) of 0.90 and for the Bother Domain (items 9-10) of 0.82. Cronbach's alpha for the subdomains were all > 0.85. Construct validity, convergent and divergent validity, internal discriminant validity, and predictive validity were all robust. The minimally important difference for the measure was determined to be 4 points (out of 32) for the Total M-ISI Severity Domain, and 1-2 points (out of 8-12) for the individual subdomains. CONCLUSIONS: The M-ISI is a parsimonious measure that has established reliability and validity on several levels and complements current clinical evaluative methods for patients with urinary incontinence.

Management of difficult cases in female urology and neurourology at the Reed M. Nesbit society meeting. Festschrift in honor of Edward J. McGuire, MD.

This is a panel discussion of seven complex urologic cases in female urology and neurourology. Differences in diagnosis and management are discussed by this international panel of experts.

Long-term durability of pubovaginal fascial slings in women who then become pregnant and deliver.

INTRODUCTION AND HYPOTHESIS: Pubovaginal fascial slings are commonly performed after childbearing is completed. Limited data is available regarding women who become pregnant following a sling procedure. METHODS: Three hundred forty-one women of childbearing age underwent pubovaginal sling surgery at our institution from July 1993 to December 2005. All patients were sent a questionnaire regarding their incontinence and health status. RESULTS: Nine women who delivered following surgery were identified (seven vaginal and two cesarean sections). Overall, five remained dry, three had no change in continence, and one noted worsening incontinence. Four women completed questionnaires (two vaginal and two caesarean sections). One patient who delivered vaginally reported high symptom scores and dissatisfaction while the remaining three reported low symptom scores and satisfaction. CONCLUSIONS: The pubovaginal fascial sling is a durable option for women with reproductive potential. Given our results, both vaginal delivery and cesarean section appear to be acceptable modes of delivery in this patient population.

Combination drug therapy improves compliance of the neurogenic bladder.

PURPOSE: Typical management of increased bladder storage pressures and decreased compliance related to neurogenic bladder dysfunction consists of antimuscarinic therapy with or without clean intermittent catheterization. However, these measures are often unsuccessful. In this patient group we commonly use combination therapy consisting of antimuscarinics combined with imipramine and/or an alpha-blocker. MATERIALS AND METHODS: A retrospective chart review was performed identifying all patients with neurogenic bladder dysfunction who were initially on no drug therapy or antimuscarinic therapy alone and were later switched to 2 or 3 drug therapy. RESULTS: In the group initially on no therapy and subsequently on 2 drugs (22) mean bladder pressure at capacity decreased 52% and mean compliance increased 5.0-fold. Similarly in the group starting without therapy but ending up on 3 drugs (28) bladder pressure decreased 67% and compliance increased 9.7-fold. In the group initially on an antimuscarinic agent alone (27) triple drug therapy decreased bladder pressure 60% and compliance increased 3.0-fold (all p <0.01). There were also improvements in incontinence, vesicoureteral reflux, detrusor overactivity and detrusor sphincter dyssynergia. CONCLUSIONS: In this highly selected group of patients with neurogenic bladder dysfunction and poor bladder compliance combination medical therapy with 2 or 3 drugs improved compliance, decreased bladder pressures at capacity and improved clinical outcomes. Combination therapy requires further study of the side effect profile but these results suggest that it should be considered for patients in whom antimuscarinic agents alone fail.

Long-term durability and functional outcomes among patients with artificial urinary sphincters: a 10-year retrospective review from the University of Michigan.

PURPOSE: The artificial urinary sphincter continues to be one of the most effective and commonly used surgical treatments for severe urinary incontinence. The long-term durability and functional outcome remains unclear. This study sought to report the artificial urinary sphincter complication rates, associated risk factors with complications, and long-term quality of life and durability. MATERIALS AND METHODS: This single institution study reports the outcomes of 124 consecutive index cases of artificial urinary sphincter from 1996 to 2006 for complications (infection, erosion, and mechanical failure). Bivariate statistics and multivariable logistic models were used to identify patient and artificial urinary sphincter characteristics associated with complications. Functional outcomes and long-term durability were assessed using a cross sectional analysis of a validated health related quality of life survey and a product limit estimates, respectively. RESULTS: Among the 124 male patients median followup was 6.8 years. The overall complication rate for patients undergoing an artificial urinary sphincter was 37.0%, with mechanical failure the most common cause (29), followed by erosion (10) and then infection (7). Significant differences between complications and specific patient and artificial urinary sphincter characteristics risk factors were not found. Functional outcomes appeared stable with similar mild-moderate urinary incontinence severity and 0 to 1 daily pad use at intervals of 0 to 4 years, 4 to 8 years and more than 8 years. Long-term durability was notable with 36% having complications (requiring surgical revision or removal) within 10 years and most events occurring within the first 48 months. CONCLUSIONS: Long-term durability and functional outcomes are achievable for the AMS 800, but there are appreciable complication rates for erosion, mechanical failure and infection in the first 48 months from implantation.

Complications requiring reoperation following vaginal mesh kit procedures for prolapse.

OBJECTIVE: The objective of the study was to the characterize the symptoms and management of vaginal mesh-related complications requiring operative intervention. STUDY DESIGN: This was a case series of patients undergoing excision of vaginal graft material. Only women who had vaginal mesh placement for the correction of pelvic organ prolapse (POP) were included. We describe the symptoms, complications, and management of women treated surgically for vaginal mesh-related complications. RESULTS: Thirteen referred women underwent surgery for vaginal mesh-related complications. All meshes were Apogee and/or Perigee. Ten had symptomatic mesh exposures, 1 had an exposure with pelvic abscess, and 2 had pain syndromes without mesh exposure. Patients also had rectovaginal fistula, vesicovaginal fistula, recurrent POP, and persistent discharge. Five women had prior surgery for this problem. All patients underwent transvaginal mesh excision and other indicated procedures at our institution, and 6 women required a second surgery at our institution, with a median of 2 surgeries per patient. CONCLUSION: Vaginal mesh placement for POP can be associated with pain, exposure, and fistula formation, requiring multiple operative interventions.

The association of Incontinence Symptom Index scores with urethral function and support.

OBJECTIVE: The objective of this study was to establish categories of symptom severity based on Incontinence Symptom Index (ISI) scores and to show how these categories are associated with urethral function and support. STUDY DESIGN: Women with stress incontinence (n = 97) and asymptomatic controls (n = 98) completed the ISI. Asymptomatic women's scores were between 0 and 6; this range was designated as absent/mild (n = 104). The median score for symptomatic women was 16; scores from 7 to 16 (n = 50) were designated as moderate, and scores of 17 or greater (n = 40) were designated as severe. RESULTS: Urethral function differed in women with mild, moderate, and severe scores: Valsalva leak point pressure (162.3 vs 123.5 vs 101.9 cm H(2)O; P = .001), cough leak point pressure (202.0 vs 163.0 vs 134.3 cm H(2)O; P = .001), and maximum urethral closure pressure (69.1 vs 44.1 vs 35.3 cm H(2)O; P = .001). Loss of urethrovesical support (point Aa: -1.0 vs -0.6 vs -0.5 cm; P = .004) was found in women with moderate and severe symptoms, compared with those with mild symptoms. CONCLUSION: Categories of symptom severity assessed by the ISI are associated with urethral function and support.

Salvage cryotherapy for recurrent prostate cancer after radiotherapy: variables affecting patient outcome.

PURPOSE: To determine the long-term disease-specific survival (DSS) and disease-free survival (DFS) rates after salvage cryotherapy for locally recurrent adenocarcinoma of the prostate and to identify pretreatment factors that have an impact on DSS and DFS. PATIENTS AND METHODS: Between July 1992 and January 1995, 131 patients who had received definitive radiation therapy (XRT) underwent salvage cryotherapy for locally recurrent adenocarcinoma of the prostate. Cryotherapy failure was defined as an increasing postcryotherapy prostate-specific antigen (PSA) level of > or = 2 ng/mL above the postcryotherapy nadir, a positive prostate biopsy, or radiographic evidence of metastatic disease. Clinical variables were studied to determine whether there was an association with the DSS and DFS. RESULTS: The median follow-up was 4.8 years. The 5-year DSS rates were 87% for patients with a precryotherapy Gleason score < or = 8 and 63% for those with Gleason scores of 9 and 10 (P =.012). The 5-year DFS rates were 57% for patients with a precryotherapy PSA level of < or = 10 ng/mL and 23% for those with a PSA level greater than 10 ng/mL (P =.0004). The 5-year DSS rates for patients with a pre-XRT clinical stage of T1 to T2 and those with a clinical stage of T3 to T4 were 94% and 72%, respectively (P =.0041). The 5-year DFS rates for these groups were 90% and 69%, respectively (P =.0057). CONCLUSION: Androgen-independent local recurrences, Gleason score, and pre-XRT clinical stage were important factors that had an impact on DSS and DFS. The subset of patients cured by salvage cryotherapy seems to be small, and patient selection is important.

Chronic toxicity in monkeys with the thiazolidinedione antidiabetic agent troglitazone.

The antidiabetic agent troglitazone was given to groups of 4 cynomolgus monkeys per sex at 300, 600, or 1200 mg/kg daily by gavage for 52 weeks. A group of 4 monkeys per sex received vehicle alone and served as controls. Emesis and soft stool or diarrhea occurred sporadically in all troglitazone-treated groups, but did not compromise animal health. There were no effects on body weight or food consumption, or ophthalmologic, electrocardiographic, or echocardiographic parameters. Erythrocyte count, hemoglobin, and hematocrit decreased 8% to 16% in males at all doses and serum cholesterol decreased 30% to 46% in both sexes at all doses. Urinary ketones were increased in several animals at 600 and 1200 mg/kg. Absolute and relative liver weights increased at all doses in both sexes by 40% to 71%. The only microscopic change attributable to troglitazone treatment was minimal to mild bile duct hyperplasia in males at all doses and in females at 600 and 1200 mg/kg. No differences in systemic exposure were apparent between sexes. Over the dose range tested, AUC(0-24) values were 27 to 102 micrograms.hr/ml of troglitazone, 401 to 2060 micrograms.hr/ml of its sulfate conjugate, and 34 to 312 micrograms.hr/ml of its quinone metabolite. Therefore, oral administration of troglitazone to monkeys at 300, 600, and 1200 mg/kg for 52 weeks resulted in significant systemic exposure, with only minimal gastrointestinal, hematologic, and hepatic effects.

Treating stress urinary incontinence in female patients with neuropathic bladder: the value of the autologous fascia rectus sling.

OBJECTIVE/BACKGROUND: The aim of this study was to evaluate the efficacy of the autologous fascia rectus sling in treating stress urinary incontinence in female patients with neuropathic bladder. Furthermore, correlations between preoperative parameters and outcome were evaluated. METHODS AND DESIGN: We retrospectively reviewed operative logs from a single surgeon (EM) of 33 female patients with neuropathic bladder treated over a 3-year period for stress urinary incontinence by implantation of an autologous fascia rectus sling. Efficacy was evaluated objectively in terms of the number of pads used per day, while subjective patient satisfaction was also recorded using a global assessment question. Possible correlations between age, obesity, preoperative Valsalva leak point pressure and incontinence severity and outcome were investigated using univariate analysis. OUTCOME MEASURES AND RESULTS: The mean follow-up time was 52 months, while the mean age of the patients was 37 years. Causes of neuropathic bladder were myelomeningocele in 21 (63.63 %) and spinal cord injury in 12 patients (36.36 %). A total of 30 patients were successfully treated and satisfied with the outcome of the operation (90.9 %). Twenty-five patients (75.75 %) were totally dry, while 5 patients (15.15 %) had markedly improved but still required one pad per day. The complication rate was 15.20 %. Univariate analysis failed to show any correlation between the final outcome and the checked parameters. CONCLUSION: The free autologous rectus fascia sling is a highly effective technique for the treatment of female stress incontinence in patients with neuropathic bladder, while the morbidity is mild.

Long-term outcomes after primary failures of artificial urinary sphincter implantation.

OBJECTIVES: To assess our institutional outcomes after primary artificial urinary sphincter (AUS) failures. METHODS: From 1985 to 2010, a total of 149 patients underwent 318 primary and additional AUS procedures. We classified additional procedures as revisions, replacements, or explantations. RESULTS: At a median of 52 months (range, 6-250 months), 53% of patients had required at least 1 additional procedure beyond their initial implantation. These included 106 (63%) revisions, 42 (24.9%) explantations, and 21 (12.4%) replacements. The most common revision was reservoir upsizing (37/106). Reasons for first revision included recurrent incontinence (56.7%), mechanical malfunction (22%), and infection or erosion (18.6%). Explantations were performed primarily for infection and erosion (64.3%). Median time to first revision was 20.1 months (range, 0.1-173 months) after implantation, with a median of 9.5 months (range, 1-102 months) between revisions. Explantation occurred at a median of 22 months (range, 1-221 months) after implant, and subsequent replacement at a median of 33.6 months (range, 2-138 months). At 5 years, 28/83 (33.7%) patients had undergone no additional procedures. Patients with previous radiation were more likely to experience infection (P = .03; OR 3.99; 95% CI 1.03-15.42). Patients with previous myocardial infarction were more likely to experience erosion (P = .04; OR 2.29; 95% CI 1.05-5.02), and obese patients were more likely to experience mechanical malfunction (P = .04; OR 2.62; 95% CI 1.07-6.4). CONCLUSIONS: More than half of patients with an AUS will require additional procedures, most likely revision. Radiation, previous myocardial infarction, and obesity are linked to complications. Median time to first revision or explantation is slightly less than 2 years, indicating that long-term follow-up is required after initial implantation.

Bone-anchored sling for male stress urinary incontinence: assessment of complications.

OBJECTIVES: To evaluate the complications associated with the male bone-anchored sling (BAS) to determine the appropriate preoperative counseling for men considering surgery. The BAS is a surgical option for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency. METHODS: We retrospectively reviewed 119 men who had undergone 140 BAS procedures for SUI from May 2000 to May 2009 at our institution. All complications were recorded during the follow-up visits. Pad test and questionnaire results were recorded, as available. RESULTS: BAS was performed in 140 cases for 119 men with SUI. Mean patient age was 65.8 years (range 23-89). Main etiologies for SUI included previous treatment of prostate cancer (82.4%), neurologic dysfunction (12.6%), and previous transurethral resection of the prostate (3.6%). Recurrent SUI, de novo urge incontinence, and wound infection were the most frequent complications encountered (25.2%, 17.6%, and 16%, respectively). The 3 most common reasons for reoperation included bulking agent injection for recurrent SUI (5.9%), sling revision for bone screw dislodgement (5.9%), and sling revision for recurrent SUI (5.0%). Overall complication and reoperation rate for the index cases was 58.8% and 26.9%, respectively. CONCLUSIONS: The incidence of complications after male BAS placement might be greater than previously reported. Patient counseling before surgery regarding the potential complications is important. Men treated for prostate cancer should be informed of the risk of recurrent SUI. In appropriately selected patients, we believe the BAS is a reasonable surgical option; however, the risk of postoperative complication is not equivocal.

Efficacy and preoperative prognostic factors of autologous fascia rectus sling for treatment of female stress urinary incontinence.

OBJECTIVE: To evaluate the efficacy of the autologous fascia rectus sling in treating female stress urinary incontinence. METHODS: A total of 264 patients treated during a 3-year period for SUI using the autologous fascia rectus sling were retrospectively reviewed. Efficacy was evaluated by the number of pads used daily. Patient satisfaction and correlations between the preoperative parameters and outcome were assessed. RESULTS: The mean follow-up time was 27.8 months. Of the 264 patients, 224 (85%) were successfully treated and satisfied with the outcome of the operation. Of the 224 patients, 200 (75.8%) were totally dry and 24 (9.1%) had improved markedly. The complication rate was 29.2%, with postoperative urgency the most common problem (49 of 264, 18.5%). None of the preoperative parameters were associated with the final outcome. CONCLUSION: The free autologous rectus fascia sling is a highly effective technique for the treatment of female stress incontinence with mild morbidity.

Factors associated with urge urinary incontinence after surgery for stress urinary incontinence.

OBJECTIVE: : The objectives of the study were to estimate the severity of urge urinary incontinence (UUI) after surgery for stress incontinence and identify factors associated with symptom severity. METHODS: : Four hundred thirty-eight women who underwent surgery for stress incontinence over a 10-year period completed a mailed questionnaire protocol that included validated instruments to assess lower urinary tract function and mental and physical well-being. Bivariate analysis and generalized linear models were used to identify factors associated with severity of UUI as measured by the urge incontinence domain of the Incontinence Symptom Index. RESULTS: : Urge urinary incontinence was experienced daily by 35.9% of patients. Factors independently associated with higher UUI severity scores were preoperative mixed urinary incontinence (P = 0.006), depression (P < 0.001), aging (P < 0.001), and longer follow-up times (P = 0.01). Pubovaginal sling (P = 0.001) and urethral vaginal suspension (P = 0.04) had higher severity scores than Tension-Free Vaginal Tape. CONCLUSIONS: : Daily episodes of UUI are experienced by slightly more than one third of women after surgery for stress incontinence. Identification of factors associated with UUI may help physicians to modify treatment and patient expectations.

Urodynamics of the neurogenic bladder.

Many patients with neurogenic bladders require careful monitoring in order to decrease the risk of infectious and renal complications. Urodynamic testing, with particular attention paid to detrusor pressures, is helpful for risk stratification in these patients and provides key information when assessing effectiveness of treatments. This article reviews the history, indications, and contemporary parameters for urodynamic testing in the neurogenic population.

Efficacy of the bulbourethral autologous sling in treating male stress urinary incontinence: a three-year experience from a single center.

AIM: To evaluate the efficacy of the bulbourethral rectus autologous sling in treating male stress urinary incontinence. PATIENTS AND METHODS: We retrospectively reviewed operative logs from a single surgeon of 32 male patients treated over a 3-year period (March 2001 to March 2004) for stress incontinence by implantation of a bulbourethral free rectus sling. The mean age of the patients was 46.4 (range 14-76); mean follow-up time was 29.5 months (range 24-52). Neurogenic dysfunction was the most common cause of incontinence in this group (17/32 cases; 53.1%). Efficacy was evaluated objectively in terms of the number of pads used per day, subjective patient satisfaction, and morbidity. We also investigated a possible correlation between pre-operative parameters and outcome. RESULTS: Ten patients (31.3%) were cured (totally dry, 15.6%; the remainder one pad per day), while five (15.6%) patients improved but still required two pads per day. Overall, 15 of 32 patients (46.9%) were satisfied with the outcome of the operation. In total, seven patients presented a mild complication (21.9%). De novo urgency was the most common complication presented in four of 32(11.6%). No case of urethral erosion was encountered. Univariate analysis failed to find any correlation between the final outcome and the following parameters: patient age, duration of incontinence, earlier anti-incontinence surgery, severity of pre-operative incontinence, pre-operative Valsalva leak point pressure, decreased compliance, decreased bladder capacity, and pre-operative evidence of detrusor overactivity. CONCLUSIONS: In conclusion, the free rectus fascia bulbourethral sling is a modestly effective technique for the treatment of male stress incontinence with mild morbidity. The use of this method seems that it is suitable for selected cases.

Multiple perineal abscesses and sinus tracts as a complication of vaginal mesh.

Understanding the occurrence and management of mesh kit complications has become increasingly important. A 54-year-old woman presented to our tertiary care center with complaints of constant perineal pain, and copious, foul-smelling vaginal discharge after anterior and posterior placement of a synthetic mesh and mid-urethral sling 3 months earlier. She was found to have two vaginocutaneous sinus tracts (to the left ischiorectal fossa and to the left labia majora), as well as bilateral abscess cavities within the ischiorectal fossae. The posterior mesh was completely excised, the tracts were opened, and the wound was packed and allowed to heal by secondary intention.

Urinary incontinence after stress incontinence surgery: a risk factor for depression.

OBJECTIVES: To determine whether urinary incontinence after stress incontinence surgery is a risk factor for concomitant symptoms of depression. METHODS: Women who underwent stress urinary incontinence surgery from 1993 to 2002 were given 2 validated quality-of-life questionnaires, the Incontinence Symptom Index and the Patient Health Questionnaire, to assess the severity of urinary incontinence symptoms after surgery and to identify moderate-to-severe depressive symptoms, respectively. Bivariate and multivariate statistical models were then constructed to determine the independent parameters associated with the reporting of moderate-to-severe depressive symptoms in this group of women. RESULTS: Of the 687 identified women, 437 (64%) returned completed questionnaires. The average patient age was 59 years, with a median follow-up after the index surgery of 2.9 years (range 0.4-10.1). Urinary incontinence after stress incontinence surgery was found to be an independent risk factor for associated moderate-to-severe depressive symptoms. Each 10-point increase in the Incontinence Symptom Index total symptom severity score resulted in a near doubling of the odds of having concomitant depressive symptoms (odds ratio 1.93, 95% confidence interval 1.41-2.65). Additional comorbid conditions (odds ratio 1.46, 95% confidence interval 1.23-1.73), additional postoperative vaginal prolapse surgery (odds ratio 3.20, 95% confidence interval 1.30-7.89), and perimenopausal status (odds ratio 3.79, 95% confidence interval 1.60-8.95) were also significantly associated with depressive symptoms. CONCLUSIONS: Urinary incontinence after stress incontinence surgery is strongly associated with moderate-to-severe postoperative depression symptoms, even years after the index surgery. Additional studies are necessary to examine the causal relationships between incontinence and depression.

"The cough game": are there characteristic urethrovesical movement patterns associated with stress incontinence?

This study was carried out to determine whether five experts in female stress urinary incontinence (SUI) could discover a pattern of urethrovesical movement characteristic of SUI on dynamic perineal ultrasound. A secondary analysis of data from a case-control study was performed. Ultrasounds from 31 cases (daily SUI) and 42 controls (continent volunteers) of similar age and parity were analyzed. Perineal ultrasound was performed during a single cough. The five experts, blinded to continence status and urodynamics, classified each woman as stress continent or incontinent. Correct responses ranged from 45.7% to 65.8% (mean 57.4 +/- 7.6). Sensitivity was 53.0 +/- 8.8% and specificity 61.2 +/- 12.4%. The positive predictive value was 48.8 +/- 8.2% and negative predictive value was 65.0 +/- 7.3%. Inter-rater reliability, evaluated by Cohen's kappa statistic, averaged 0.47 [95% CI 0.40-0.50]. Experts could not identify a pattern of urethrovesical movement characteristic of SUI on ultrasound.