Cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® compared with mid-urethral sling surgery for stress urinary incontinence: A two-arm cohort study.

OBJECTIVE: To investigate the cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® (PDMS-U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1-year follow-up. DESIGN: Prospective, two-arm cohort study with 2-year follow-up. SETTING: International multicentre. POPULATION: Women with moderate to severe SUI. MAIN OUTCOME MEASURES: Primary outcome was subjective cure (Patient Global Impression of Improvement). SECONDARY OUTCOMES: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI-6), complications and re-interventions. Cost-effectiveness outcomes: total costs, quality-adjusted life year (QALY) using IIQ7-scores (Incontinence Impact Questionnaire) and EQ-5D-5L, incremental cost-effectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). RESULTS: In all, 131 PDMS-U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS-U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS-U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS-U and MUS surgery were €3567 and €6688. ICER for MUS surgery cost €15 598 per IIQ QALY and €37 408 per EQ-5D-5L QALY. With a willingness to pay (WTP) of €25 000, MUS has a 84% chance of being cost-effective using IIQ, whereas PDMS-U has a 99% chance of being cost-effective using EQ-5D-5L. CONCLUSION: MUS surgery is more cost-effective in realising improved disease-specific quality of life (QoL), while PDMS-U is more cost-effective in realising improved generic QoL.

Multicentered Assessment of Clinical Outcomes and Factors Associated With Failure of the Adjustable TransObturator Male System (ATOMS).

OBJECTIVE: To assess postoperative outcomes from the Adjustable TransObturator Male System (ATOMS) and identify factors influencing failure to achieve continence. PATIENTS AND METHODS: A multicentered analysis was performed on all patients treated for postprostatectomy incontinence using the third-generation ATOMS at 9 Canadian tertiary referral centers. The primary outcome was continence (defined as requiring ≤1 pad postoperatively for patients requiring ≥2 pads preoperatively and 0 pads for those requiring 1 pad preoperatively). Secondary outcomes included improvement (>50% change in pad use), patient satisfaction, explantation, and postoperative complications. RESULTS: Two hundred and eighty nine patients with a mean age of 68.9 years were analyzed. Pre-operatively mean pad per day use was 4.2 (1-12), 31.5% of patients reported severe incontinence (≥5 pads/day), 33.9% had concurrent radiotherapy and 19.4% had failed previous incontinence surgery. Overall continence rate was 73.3% (n = 212) at a mean follow-up of 19.6 months. More than eighty nine percent (89.3%) (n = 258) of patients experienced >50% improvement, 84.4% (n = 244) of patients were satisfied with the results of surgery. More than seven percent (7.9%) (n = 23) required device explantation. On multivariate Cox regression analysis, concurrent radiotherapy (hazard ratio [H.R.] 2.3, P < .001), diabetes (H.R. 2.2, P = .007) and increased pre-operative pad usage (H.R. 1.1, P = .02) were each associated with failure to achieve continence, while patient age (P = .60), obesity (P = .08), prior urethral stenosis (P = .56), and prior incontinence surgery (P = .13) were not. Radiation therapy was also associated with device explantation (H.R. 2.7, P = .02). CONCLUSION: ATOMS is a safe and efficacious for treatment of postprostatectomy incontinence. However, patients with prior radiation, increased pre-operative pad use, or diabetes are less likely to achieve continence.

Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound.

PURPOSE: The primary objective was to evaluate the effect of autologous muscle-derived cell (AMDC) injections on the urethral sphincter morphometry compared to placebo injections. Secondary aims were to explore the reduction of stress incontinence episode frequency (IEF) and factors associated with the efficacy of AMDC. METHODS: This prospective randomized-controlled study compared the urethral sphincter volumes of participants who had received either an intra-sphincteric injection of 4 cc AMDC in injection media or 4 cc placebo solution, using a transperineal 3D/4D ultrasound at baseline and at 12 months. The reduction of stress IEF on 3-day bladder diary and potential predictors at baseline for response to AMDC were assessed. RESULTS: Fifty-eight participants were included in the study. Compared to baseline, the mean total and external sphincter volumes increased significantly in both groups (respectively, p = 0.001 and p < 0.001 in the AMDC group, p < 0.001 and p = 0.005 in the placebo group) at 12 months. Both groups showed a significant reduction of stress IEF compared to baseline (p = 0.03 and p ≤ 0.001 for AMDC and placebo groups, respectively). There were no between-group differences regarding total and external sphincter volumes and reduction of stress IEF. A longer urethral length (p ≤ 0.001) and a larger external sphincter volume (p ≤ 0.05) were significantly associated with lower stress IEF. CONCLUSION: Significant increases of sphincter volumes as well as reduction of stress IEF occurred among the AMDC and placebo injection groups with no between-group differences at 12 months. A longer urethral length and a larger external sphincter volume at baseline were identified as potential predictors of AMDC injection response.

Development of a urinary incontinence educational program using a competency-based approach and case method.

Nurses have limited knowledge about urinary incontinence and find it difficult to care for those who suffer from it, yet there is little training on incontinence designed for nurses. Hence, there is a real need to develop and evaluate an appropriate urinary incontinence educational program. A critical issue is the choice of teaching strategies designed to integrate learning. This article describes the competency-based approach and case method used to develop a urinary incontinence education program.

Creation and testing of the Geriatric Self-Efficacy Index for Urinary Incontinence.

OBJECTIVES: To report on the content development, construct validity, and reliability testing of the Geriatric Self-Efficacy Index for Urinary Incontinence (GSE-UI). DESIGN: Prospective cohort study. SETTING: Six UI outpatient clinics in Quebec, Canada. PARTICIPANTS: Community-dwelling incontinent men and women aged 65 and older. MEASUREMENTS: Thirty-eight items were generated using a literature search and interdisciplinary panel of experts. Item reduction was achieved through field-testing with 75 older men and women with UI attending an information session. The final 20-item draft, measuring older adults' level of confidence in preventing urine loss, was administered to a new group of consecutive patients 1 week before and at the time of their first visit to the UI clinic to enable evaluation of test-retest reliability. A 3-day voiding diary, quantifying the frequency of UI, and the Incontinence Quality of Life questionnaire were used to test construct validity. RESULTS: One hundred sixteen of 300 eligible patients (39%) participated (mean age+/-standard deviation 74+/-6, range 65-87). The GSE-UI items showed normal distributions and no ceiling effects. Self-efficacy scores ranged from 16 to 193 (mean 104+/-41, possible range 0-200) and correlated positively with quality of life scores (r=0.7, P<.001) and negatively with UI severity (r=-0.4, P<.001). Internal consistency for the GSE-UI was 0.94 (Cronbach alpha). Initial test-retest reliability of the 20 items using intraclass correlations ranged from 0.50 to 0.86. CONCLUSION: The GSE-UI will enable measurement of whether a person's confidence in their ability to prevent urine loss is an important mechanism contributing to improvements in UI.