Perioperative Mobile Telehealth Program for Post-Prostatectomy Incontinence: A Randomized Clinical Trial.

PURPOSE: Perioperative pelvic floor muscle training can hasten recovery of bladder control and reduce severity of urinary incontinence following radical prostatectomy. Nevertheless, most men undergoing prostatectomy do not receive this training. The purpose of this trial was to test the effectiveness of interactive mobile telehealth (mHealth) to deliver an evidence-based perioperative behavioral training program for post-prostatectomy incontinence. MATERIALS AND METHODS: This was a 3-site, 2-arm, randomized trial (2014-2019). Men with prostate cancer scheduled to undergo radical prostatectomy were randomized to a perioperative behavioral program (education, pelvic floor muscle training, progressive exercises, bladder control techniques) or a general prostate cancer education control condition, both delivered by mHealth for 1-4 weeks preoperatively and 8 weeks postoperatively. The primary outcome was time to continence following surgery measured by the ICIQ (International Consultation on Incontinence Questionnaire) Short-Form. Secondary outcomes measured at 6, 9 and 12 months included Urinary Incontinence Subscale of Expanded Prostate Cancer Index Composite; pad use; International Prostate Symptom Score QoL Question and Global Perception of Improvement. RESULTS: A total of 245 men (ages 42-78 years; mean=61.7) were randomized. Survival analysis using the Kaplan-Meier estimate showed no statistically significant between-group differences in time to continence. Analyses at 6 months indicated no statistically significant between-group differences in ICIQ scores (mean=7.1 vs 7.0, p=0.7) or other secondary outcomes. CONCLUSIONS: mHealth delivery of a perioperative program to reduce post-prostatectomy incontinence was not more effective than an mHealth education program. More research is needed to assess whether perioperative mHealth programs can be a helpful addition to standard prostate cancer care.

Effects of behavioral and drug therapy on nocturia in older incontinent women.

OBJECTIVES: To examine changes in nocturia from a multicomponent behavioral training program or drug therapy in older women with urge or mixed (urge-predominant) urinary incontinence. DESIGN: A secondary analysis of data from a prospective, randomized clinical trial. SETTING: Parent trial was an outpatient research protocol in Alabama. PARTICIPANTS: One hundred ninety-seven women (aged 55-92) with incontinence and urodynamic evidence of bladder dysfunction. At baseline, 131 women (66% of participants) had nocturia. INTERVENTION: In the parent study, participants received behavioral training, including four sessions of biofeedback-assisted pelvic floor muscle exercises, drug treatment (oxybutynin IR titrated from 2.5 mg per day to 5.0 mg three times a day), or placebo. MEASUREMENTS: Participant-completed bladder diaries were used to calculate changes in nocturia. RESULTS: Behavioral training reduced nocturia by a median 0.50 episodes per night and was significantly more effective than drug treatment (median reduction=0.30 episodes; P=.02) and placebo (median reduction=0.00 episodes; P<.001). Also, drug treatment was more effective than control (P=.007). CONCLUSION: Both behavioral training and drug treatment reduced nocturia more than placebo, but behavioral training was the most effective.

Urinary incontinence in the 12-month postpartum period.

OBJECTIVE: To describe the prevalence and severity of urinary incontinence in the 12-month postpartum period and to relate this incontinence to several potential risk factors including body mass index, smoking, oral contraceptives, breast-feeding, and pelvic floor muscle exercise. METHODS: Participants were 523 women, aged 14 to 42 years, who had obstetrical deliveries. The women were interviewed in their rooms on postpartum day 2 or 3 and by telephone 6 weeks, 3 months, 6 months, and 12 months postpartum. Chart abstraction was conducted to obtain obstetrical data from the index delivery. RESULTS: At 6 weeks postpartum, 11.36% of women reported some degree of urinary incontinence since the index delivery. Although the rate of incontinence did not change significantly over the postpartum year, frequency of accidents decreased over time. In the generalized estimating equation, postpartum incontinence was significantly associated with seven variables: baseline report of smoking (odds ratio [OR] 2.934; P =.002), incontinence during pregnancy (OR 2.002; P =.007), length of breast-feeding (OR 1.169; P =.023), vaginal delivery (OR 2.360; P =.002), use of forceps (OR 1.870; P =.024), and two time-varying covariates: frequency of urination (OR 1.123; P = <.001) and body mass index (OR 1.055; P =.005). Factors not associated with postpartum incontinence included age, race, education, episiotomy, number of vaginal deliveries, attendance at childbirth preparation classes, and performing pelvic floor muscle exercises during the postpartum period. CONCLUSION: Postpartum incontinence is associated with several risk factors, some of which are potentially modifiable and others that can help target at-risk women for early intervention.

Predictors of outcome in the behavioral treatment of urinary incontinence in women.

OBJECTIVE: To identify predictors of outcome of a multicomponent behavioral training program for urge and stress incontinence in women. METHODS: This report is a secondary analysis of data from three prospective, randomized, clinical trials testing behavioral interventions for urinary incontinence. Participants were a volunteer sample of 258 ambulatory, nondemented, community-dwelling women, aged 40-92 years, with stress, urge, or mixed urinary incontinence. Participants received 8 weeks (four visits) of multicomponent behavioral training in each study. The relationship between a number of variables and treatment success were explored by univariate and multivariable logistic regression analyses. RESULTS: Successful treatment of predominantly urge incontinence (75% reduction of incontinent episodes as recorded on bladder diary) was associated with not wearing any form of protection for incontinence (P = .045; 95% confidence interval [CI] .282, .987). Achieving total continence (100% reduction) was associated with fewer incontinent episodes at baseline (P < .001; 95% CI .138, .557), previous surgery for incontinence (P = .021; 95% CI 1.169, 6.543), and lower education level (P = .022; 95% CI .175, .871). Successful treatment of predominantly stress incontinence (75% reduction) was related to not having previous evaluation or treatment for incontinence (P = .001; 95% CI .026, .415), and fewer incontinent episodes on baseline bladder diary (P = .026; 95% CI .210, .907). Outcomes were not associated with age, race, type of incontinence, or a number of other variables reflecting medical history, obstetric history, medications, pelvic examination, body mass index, urodynamic parameters, or psychological distress. CONCLUSION: Aside from indicators of severity and previous treatment, there were few associations between baseline clinical variables and outcome of behavioral treatment.

Tension-free vaginal tape: a prospective subjective and objective outcome analysis.

The purpose of this prospective study was to describe the effects of the tension-free vaginal tape (TVT) procedure on subjective and objective outcomes. Eighty-seven women (aged 31-95 years) underwent a TVT procedure and were followed for up to 24 months using the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), and a Patient Satisfaction Questionnaire. IIQ-7 scores improved from a mean 51.1 before surgery to 12.7 at 1 month (p<0.001) indicating reduced impact of incontinence on quality of life. UDI-6 scores declined from a mean 61.8 to 21.9 (p<0.001) indicating improvement in urinary symptoms. At 1 month, 91.2% of patients were satisfied. Improvements on all measures were maintained throughout follow-up. Urodynamic evaluation of 57 patients (mean: 15.0 months) showed that 91.2% had a negative stress test. Results indicate significant immediate and sustained improvement in incontinence impact and urinary symptoms, and a high rate of patient satisfaction and objective cure.

Cadaveric fascia lata sling for stress urinary incontinence: a prospective quality-of-life analysis.

OBJECTIVE: The purpose of this study was to describe the effects of full-length cadaveric fascia lata (CFL) sling on quality-of-life outcomes. STUDY DESIGN: Patients were 102 women (aged 29 to 87 years) who underwent the sling procedure for stress incontinence associated with intrinsic sphincter deficiency. They were followed up at 12, 24, 36, and 48 months with the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), and a patient satisfaction questionnaire. RESULTS: Mean IIQ score declined from 55.1 before surgery to 11.0 at 12 months (P<.001). Mean UDI score declined from 67.1 to 28.0 at 12 months (P<.01). At 12 months, 79.7% of patients reported that leakage was better or much better, and 90.2% reported that they were somewhat or completely satisfied with their progress. Results were maintained throughout the 48-month follow-up period. CONCLUSION: The CFL sling procedure has an enduring beneficial effect on lower urinary tract symptoms and quality of life.