Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence

ABSTRACT

Objective: To assess the effects of tolterodine extended release (ER) on patient-reported outcomes (PROs) in sexually active women with overactive bladder (OAB) and urgency urinary incontinence (UUI).

Research design and methods: This multicenter, double-blind, placebo controlled trial included 411 women aged ≥18 years reporting OAB symptoms for ≥3 months; ≥8 micturitions per 24 hours (including ≥0.6 UUI episodes and ≥3 OAB micturitions) in 5-day bladder diaries at baseline, and being in a sexually active relationship for ≥6 months. Subjects randomized to placebo or tolterodine ER completed validated OAB- or incontinence-specific questionnaires, including the Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), Urgency Perception Scale (UPS), and the Incontinence Impact Questionnaire (IIQ) at baseline and week 12, as well as the Perception of Treatment Benefit and Treatment Satisfaction questions at week 12. This study is registered with ClinicalTrials.gov (identifier: NCT00143481)

Results: The mean age of enrolled women was approximately 48 years. Compared with placebo, the tolterodine ER group reported significant baseline to week 12 improvements in PPBC responses (p = 0.0048); OAB-q Symptom Bother, total Health-Related Quality of Life (HRQL), and HRQL domain scores (all p < 0.05); IIQ Emotional Health domain scores (p < 0.05); proportions of subjects reporting treatment benefit (79 vs. 54%; p < 0.0001) and satisfaction (78 vs. 59%; p < 0.0001). Improvements on the UPS were not significantly different.

Conclusions: Tolterodine ER treatment was associated with improvements in multiple OAB- and incontinence-specific PROs in a sexually active, relatively young, and racially diverse population of women. The findings provide clinicians with new insights into the impact of OAB and its treatment on HRQL in this population, which has been underrepresented in previous OAB studies. Study limitations include a potential underestimation of the impact of OAB symptoms resulting from the exclusion of women who may not be sexually active because of their urinary symptoms.

Trial registration: ClinicalTrials.gov identifier: NCT00143481.

Keywords: :

• Overactive bladder
• Patient-reported outcomes
• Sexual health
• Urgency urinary incontinence
• Women

Transparency

Declaration of funding

This study was funded by Pfizer Inc.

Declaration of financial/other relationships

Z.J., J.D.M., Z.G., T.B. and F.S. have disclosed that they are employed by Pfizer Inc. R.G.R. has disclosed that she received speaker honoraria and research funding support from Pfizer Inc, and has served a consultant for Pfizer Inc. She also has disclosed that she serves on the advisory board for American Medical Systems. G.B. has disclosed that she has served as a consultant and received research funding support from Astellas Pharma, Inc, Wyeth, and other pharmaceutical companies. H.S. has disclosed that she has received speaker honoraria from Pfizer Inc, Astellas Pharma, Inc, and Watson Inc.

All peer reviewers receive honoraria from CMRO for their review work. Peer reviewer 1 has disclosed that he/she is on the speakers’ bureau of Watson Pharmaceuticals. Reviewer 2 has no relevant financial relationships.

Acknowledgment

Editorial support was provided by Simon J. Slater, PhD, at Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

Data from this study were published as an abstract (Bachmann et al., Fertility & Sterility 2007:88:S248–9) and were presented at the American College of Obstetricians and Gynecologists 56th Annual Clinical Meeting, May 3–7, 2008, New Orleans, LA, USA; the American Society for Reproductive Medicine 63rd Annual Meeting, October 13–17, 2007, Washington, DC, USA; and the American Urogynecologic Society 29th Annual Scientific Meeting, September 4–6, Chicago, IL, USA.