Veronica Mallett

Behavioral Therapy to Enable Women with Urge Incontinence to Discontinue Drug Treatment: A Randomized Trial

BACKGROUND Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. OBJECTIVE To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. DESIGN 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. SETTING 9 university-affiliated outpatient clinics. PATIENTS 307 women with urge-predominant incontinence. INTERVENTION 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. MEASUREMENTS The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. RESULTS 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). LIMITATIONS Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. CONCLUSION The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

Quality of life in women with stress urinary incontinence

The objective of this study was to identify clinical and demographic factors associated with incontinence-related quality of life (QoL) in 655 women with stress urinary incontinence who elected surgical treatment. The following factors were examined for their association with QoL as measured with the Incontinence Impact Questionnaire (IIQ): number of incontinence (UI) episodes/day; self-reported type of UI symptoms (stress and urge); sexual function as measured by the Prolapse/Urinary Incontinence Sexual Questionnaire; symptom bother as measured by the Urogenital Distress Inventory; as well as other clinical and sociodemographic factors. A stepwise least-squares regression analysis was used to identify factors significantly associated with QoL. Lower QoL was related to the greater frequency of stress UI symptoms, increasing severity, greater symptom bother, prior UI surgery or treatment, and sexual dysfunction (if sexually active). Health and sociodemographic factors associated with lower incontinence-related QoL included current tobacco use, younger age, lower socioeconomic status, and Hispanic ethnicity.

The expectations of patients who undergo surgery for stress incontinence

OBJECTIVE The purpose of this study was to assess patient expectations of surgical outcome after preoperative counseling of surgical procedures in a randomized trial of 655 women in a comparison of the rectus fascial sling and Burch colposuspension. STUDY DESIGN Women who selected surgery for treating stress incontinence and who consented to this randomized, surgical trial completed a preoperative questionnaire to assess expectations for the postsurgical effects of surgery on urinary incontinence-related symptoms, limitations, and emotions. Associations of expectations with a range of preoperative urinary incontinence measures were explored. RESULTS The most frequent preoperative symptoms were urine leakage (98%), embarrassment (88%), frequency (74%), physical activity (72%), and urgency (70%). Sexual and social limitations were less frequent (< or = 44%). Treatment expectations were higher for women who reported more symptom bother. As expected, most women (98%) had an expectation that urine leakage would be completely or almost completely eliminated. However, most women (92%) who reported urgency or frequency (83%) expected significant improvement of these symptoms after surgery. CONCLUSION Patients who undergo stress incontinence surgery have high expectations regarding the outcome of incontinence surgery, which include the resolution of urgency and frequency.

Epidemiology of lower urinary tract dysfunction

Introduction A plethora of new prevalence studies of urinary incontinence and other forms of lower urinary tract dysfunction has advanced our understanding of the epidemiology of these conditions, in the United States and worldwide. As such, racial and ethnic differences are beginning to be understood and defined. Likewise, correlates and potential risk factors are emerging. More work still needs to be done, especially in longitudinal observation that is essential to learn more about incidence and risk factors. Lastly, the area of prevention of urinary incontinence is truly in its infancy. These are major challenges in epidemiological study as longitudinal and preventive studies are time consuming and expensive. Nevertheless, this must be our goal to unravel the mystery of urinary incontinence and ultimately prevent its occurrence. Definitions

Pelvic-Floor Strength in Women With Incontinence as Assessed by the Brink Scale

Background and Purpose: The purpose of this study was to describe how clinical pelvic-floor muscle (PFM) strength (force-generating capacity) is related to patient characteristics, lower urinary tract symptoms, and fecal incontinence symptoms. Subjects: Data were obtained from 643 women who were participating in a randomized surgical trial for treatment of stress urinary incontinence. Methods: Patient demographic variables, baseline urinary and fecal incontinence symptom questionnaires, urodynamic data and urinary diary data, pad test results, and standardized assessment of pelvic organ support were compared with PFM strength as described by the Brink scoring system. Bivariate analysis of factors associated with the Brink scale score was done using analysis of variance and linear regression. Multivariate analysis included patient variables that were significant on bivariate analysis. Results: The mean Brink scale score was 9 (SD=2) and did not vary widely in this large, but highly select, patient sample. We found a weak, but statistically strong, relationship between age and Brink score. Brink scores were not related to diary and pad test measures of incontinence severity. Discussion and Conclusion: Overall, PFM strength was good in this sample of women with stress incontinence. Scores tended to be similar, and it is possible that the Brink scale does not reflect real clinical differences in PFM strength.

Risk factors for ureteral occlusion during transvaginal uterosacral ligament suspension.

Introduction and hypothesisTo determine any risk factors associated with ureteral occlusion during transvaginal uterosacral ligament suspension (USLS).MethodsA retrospective query to identify patients that underwent transvaginal USLS at a teaching hospital from 2008 to 2013 was performed. Patients in which ureteral occlusion was identified by cystoscopy were identified (cases), and compared with those without occlusion (controls). Medical records were reviewed for data abstraction. Variables compared between cases and controls included demographics, medical history/examination, concomitant procedures, number of suspension sutures placed, estimated blood loss and length of hospital stay. Univariate analyses were performed to identify potential risk factors for ureteral occlusion, followed by multivariate regression analysis to estimate odds ratios for identified predictors.ResultsA total of 144 USLS procedures were performed. Thirteen cases of ureteral occlusion were identified (9%). Baseline prolapse stage, body mass index, parity, previous hysterectomy or pelvic surgery of the groups were similar (all P > 0.05). Univariate analysis identified age (P = 0.04), concomitant anterior colporrhaphy (P = 0.01), and use of a suture-capturing device for suture placement (P = 0.04) as significant factors. On multivariate logistic regression analysis, concomitant anterior colporrhaphy increased ureteral occlusion risk (OR 10.5, 95%CI 2.37–74.99, P = 0.001), while use of a suture-capturing device decreased it (OR 0.1, 95%CI 0–0.41, P = 0.01). The mean number of suspension sutures placed per side was similar in the two groups (2.6 [range 2–4] for cases and 2.4 [range 1–4] for controls, P = 0.15).ConclusionsDuring transvaginal USLS, performance of a concomitant anterior colporrhaphy increased the risk of ureteral occlusion, while the use of a suture-capturing device for suspension suture placement was associated with decreased risk.

Knowledge, Perceptions, and Attitudes Toward Pelvic Organ Prolapse and Urinary Incontinence in Spanish-Speaking Latinas

Objectives The aim of the study was to explore individual views and perceptions of Spanish-speaking Latinas living on the US/Mexico border toward pelvic organ prolapse (POP) and urinary incontinence (UI), including awareness of conditions, implications of diagnoses, knowledge, and attitudes toward available treatment options. Methods Spanish-speaking Latina women were recruited from clinics at Texas Tech University Health Sciences Center El Paso. Focus group discussions were conducted, addressing topics including female pelvic anatomy, perceived etiology and course of POP and UI, and attitudes toward treatment options. Discussions were transcribed and qualitative analysis performed to identify common themes and concepts. Results Twenty-four women participated in 5 focus groups as follows: 2 groups of women diagnosed with POP/UI, 2 groups of women with POP/UI symptoms, and 1 group of asymptomatic women. Mean age of participants was 52 years. Participants had a good basic understanding of pelvic organs and function. The following 3 common themes were derived from our analysis: culture, barriers, and misconceptions. Concepts identified from common themes included views of POP/UI as “abnormal” conditions; perceptions that providers may downplay or ignore symptoms of POP/UI; fear of doctor; views of cancer as a common POP complication; embarrassment; views of “massage” therapy as an effective treatment for POP; and willingness to consider all available treatment options for POP and UI, including pessary. Conclusions Findings suggest need for patient reassurance about the prevalence and benign course of POP and UI upon initial assessment, with continued reinforcement of basic concepts after diagnosis, and need for increased awareness and information resources for healthcare providers and Spanish-speaking Latina women regarding these common pelvic floor disorders.

Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes

ABSTRACT Objective: Health-related quality of life (HRQoL) data for black patients receiving overactive bladder (OAB) treatment have not been previously reported. This study presents patient-reported outcomes, measured by symptom bother and HRQoL, in black patients participating in an open-label study of solifenacin succinate. Results are presented, as are those from the full study population. Methods: In the 12-week, VESIcare Open-Label Trial (VOLT), patients received solifenacin 5 mg or 10 mg once daily according to an individualized, flexible-dosing regimen. A post-hoc analysis assessed solifenacin efficacy and safety in blacks (n = 274). Three patient-derived indices served as study endpoints. The Patient Perception of Bladder Condition (PPBC) scale assessed overall symptom bother, a visual analog scale (VAS) recorded individual symptom bother, the Overactive Bladder Questionnaire (OAB-q) measured OAB-related HRQoL. Results: Blacks reported significant reductions in bladder-related problems based on PPBC scores ( p < 0.001) and improvements in all OAB-q subscales (symptom severity, coping, concern, sleep, social, and HRQoL; p < 0.001). Based on VAS ratings, significant improvements were reported for urinary urgency, urge incontinence, frequency, and nocturia ( p < 0.001 for change from baseline). Although this study was not placebo-controlled and statistical comparisons were not made, results were similar in the full study population. In total, 46% of black patients experienced adverse events (mostly anticholinergic) and 7.6% discontinued treatment as a result. Conclusions: Solifenacin treatment was perceived as offering relief from symptom bother and improving HRQoL in the black cohort from VOLT. These results are similar to those in the full VOLT population.