Rogers Rebecca G, Bachmann Gloria, Scarpero Harriette, Jumadilova Zhanna, Sun Franklin, Morrow Jon D, Guan Zhonghong, Bavendam Tamara
Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM 87131, USA.
Curr Med Res Opin. 2009 Sep;25(9):2159-65. doi: 10.1185/03007990903103279.
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).
This multicenter, double-blind, placebo controlled trial included 411 women aged > or =18 years reporting OAB symptoms for > or =3 months; > or =8 micturitions per 24 hours (including > or =0.6 UUI episodes and > or =3 OAB micturitions) in 5-day bladder diaries at baseline, and being in a sexually active relationship for > or =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).
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.
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.
评估托特罗定缓释制剂（ER）对患有膀胱过度活动症（OAB）和急迫性尿失禁（UUI）的性活跃女性患者报告结局（PROs）的影响。
这项多中心、双盲、安慰剂对照试验纳入了411名年龄≥18岁、报告OAB症状≥3个月的女性；在基线期的5天膀胱日记中，每24小时排尿≥8次（包括≥0.6次UUI发作和≥3次OAB排尿），并且处于性活跃关系≥6个月。随机分配至安慰剂组或托特罗定ER组的受试者在基线期和第12周完成了经过验证的OAB或失禁特异性问卷，包括膀胱状况患者感知问卷（PPBC）、膀胱过度活动症问卷（OAB-q）、急迫感知量表（UPS）和失禁影响问卷（IIQ），以及在第12周的治疗益处感知和治疗满意度问题。本研究已在ClinicalTrials.Gov注册（标识符：NCT00143481）。
入组女性的平均年龄约为48岁。与安慰剂相比，托特罗定ER组报告PPBC反应从基线到第12周有显著改善（p = 0.0048）；OAB-q症状困扰、总体健康相关生活质量（HRQL）和HRQL领域得分（均p < 0.05）；IIQ情绪健康领域得分（p < 0.05）；报告治疗益处的受试者比例（79%对54%；p < 0.0001）和满意度（78%对59%；p < 0.0001）。UPS的改善无显著差异。
在性活跃、相对年轻且种族多样的女性人群中，托特罗定ER治疗与多种OAB和失禁特异性PROs的改善相关。这些发现为临床医生提供了关于OAB及其治疗对该人群HRQL影响的新见解，而该人群在以往的OAB研究中代表性不足。研究局限性包括，由于排除了可能因泌尿症状而无性活跃的女性，可能低估了OAB症状的影响。
