Efficacy of tolterodine extended release (TER) for patient-reported outcomes (PROs) in sexually active postmenopausal women with overactive bladder (OAB) and urgency urinary incontinence (UUI)

Abstract

To evaluate the efficacy of TER on PROs in sexually active, postmenopausal women with OAB. Double-blind, placebo (PBO)–controlled trial of TER. This was a post hoc analysis of data from the subset of postmenopausal women with self-reported OAB (≥8 voids, ≥3 urgency-related voids, and a mean ≥0.6 UUI episodes per 24 h) for ≥3 mo. Subjects were sexually active (self defined) and in a relationship with a man for ≥6 mo. Subjects were randomized to TER (4 mg) or PBO for 12 weeks. At baseline and week 12, subjects completed the Patient Perception of Bladder Condition (PPBC) and Overactive Bladder Questionnaire (OAB-q), which has a Symptom Bother scale and a health-related quality of life (HRQL) scale comprising 4 domains. Subjects also completed the Sexual Quality of Life Questionnaire-Female (SQOL-F) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function (PISQ). Of the safety population, 51% (n = 211) of women were postmenopausal. After 12 weeks, intent-to-treat postmenopausal women who received TER showed statistically significantly greater improvements on the PPBC vs. PBO; twice as many TER vs. PBO-treated subjects showed major improvement (Figure). Subjects who received TER also showed significant improvements on all scales/domains of the OAB-q except Social Interaction. The treatment difference was significant for the PISQ but not the SQOL-F (Table 1); the SQOL-F may be less sensitive to the OAB-specific impact on sexual quality of life in these women.TableOAB-q, SQOL-F, and PISQ Results∗InstrumentTreatment Difference¶P ValueQAB-q Symptom Bother−10.9 (3.2)0.0008 Total HRQL9.3 (2.8)0.001 Concern12.3 (3.3)0.0003 Coping10.6 (3.2)0.001 Sleep7.4 (3.6)0.0424 Social Interaction3.9 (2.1)0.0613SQOL-F Total4.2 (2.5)0.0898PISO Total2.9 (1.3)0.0237∗One outlier was excluded from the analysis based on the UUI endpoint after statistical and clinical evaluation.†Lease squares mean (SD): positive score changes indicate improvement for all items except Symptom Bother. Open table in a new tab ∗One outlier was excluded from the analysis based on the UUI endpoint after statistical and clinical evaluation. †Lease squares mean (SD): positive score changes indicate improvement for all items except Symptom Bother. In sexually active postmenopausal women, TER improved patients' perceptions of the extent of their bladder problems and improved other measures of OAB symptom bother, HRQL, and sexual quality of life.