By Laura Gater
CHICAGO -- September 9, 2008 -- Tolterodine Extended Relief (ER) appears to significantly improve overactive bladder (OAB) symptoms and health-related quality of life (HRQL) in women, according to a study presented here at the American Urogynecologic Society 29th Annual Scientific Meeting (AUGS).
Rebecca Rogers, MD, Department of Obstetrics/Gynecology, University of New Mexico School of Medicine, Albuquerque, New Mexico, presented the study results on September 5.
The long-term effects, safety, and tolerability of tolterodine ER have been demonstrated in previous studies, but the duration of the drug's effects have not been evaluated, Dr. Rogers noted. In their study, Dr. Rogers and colleagues measured improvements in symptoms and HRQL over a 24-week period in sexually-active women with OAB and urgency urinary incontinence (UUI) treated with tolterodine ER.
The study enrolled 202 women randomised to treatment with tolterodine ER or placebo for 12 weeks; 161 women who remained in the study were subsequently treated in the study's 12-week open-label phase.
Subjects also completed a 5-day bladder diary, the Overactive Bladder Questionnaire (OAB-q) throughout the treatment periods. At baseline and at weeks 12 and 24, the women were evaluated using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), the Sexual Quality of Life-Female questionnaire (SQOL-F), and the Hospital Anxiety and Depression Scale (HAD).
The cohort was a mean of 50 years old; 33% of the women were less than 45 years old.
Results at week 12 showed significant improvements in all endpoints that were maintained during the open-label phase, noted Dr. Rogers. At week 12, 57% of subjects reported no UUI episodes; at week 24, 70% reported no UUI episodes. Sexual function also continued to improve when compared with baseline, especially in the PISQ.
Tolterodine ER was associated with significant improvement in OAB symptoms and HRQL scores during the 12-week double-blind phase, and improvements were maintained or became significantly greater during the subsequent 12-week open-label phase.
Patients reporting no UUI episodes on the 5-day diary also showed continued improvement from week 12 to week 24.
Long-term compliance with OAB pharmacotherapy may be important to optimise treatment outcomes, Dr. Rogers noted.
[Presentation title: Continued Improvement in Overactive Bladder Symptoms and Quality of Life in Sexually Active Women With Overactive Bladder and Urgency Urinary Incontinence Treated With Tolterodine Extended Release for 6 Months. Paper 64]