A randomized controlled trial of duloxetine alone, pelvic floor muscle training alone, combined treatment and no active treatment in women with stress urinary incontinence
A randomized controlled trial of duloxetine alone, pelvic floor muscle training alone, combined treatment and no active treatment in women with stress urinary incontinence
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DOI：
10.1097/01.ju.0000154167.90600.c6
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发表时间：
2005-05-01
影响因子：
6.6
通讯作者：
Bump, RC
中科院分区：
文献类型：
--
作者：
Ghoniem, GM;Van Leeuwen, JS;Bump, RC
目的：我们主要比较联合盆底肌训练（PFMT）和度洛西汀与仿制PFMT和安慰剂对女性压力性尿失禁（SUI） 12周的疗效。此外，我们比较了联合治疗与单独治疗、单独治疗与单独治疗、单独治疗与不治疗的疗效。材料和方法：这项盲法、双对照、随机试验在荷兰、英国和美国的17个尿失禁中心招募了201名18至75岁SUI女性。女性平均每天失禁2次或以上，随机分为每天80mg度洛西汀、安慰剂、PFMT和仿制PFMT的4种组合，包括联合治疗（52例）、不积极治疗（47例）、仅PFMT（50例）和仅度洛西汀（52例）。主要疗效指标为尿失禁发作频率。其他疗效变量包括使用失禁垫的数量和失禁生活质量问卷得分。结果：治疗人群尿失禁发作频率分析表明，与不治疗或单独使用PFMT相比，度洛西汀与不使用PFMT相比具有优势。然而，尿垫和尿失禁的生活质量分析表明，联合治疗比单一治疗有更大的改善。一项完整的人群分析证明了度洛西汀联合或不联合PFMT的疗效，并表明联合治疗比单独治疗更有效。结论：数据支持PFMT联合度洛西汀治疗女性SUI的显著疗效。我们假设度洛西汀和PFMT的互补作用模式可能导致联合治疗的叠加效应。
Purpose: We primarily compared the effectiveness of combined pelvic floor muscle training (PFMT) and duloxetine with imitation PFMT and placebo for 12 weeks in women with stress urinary incontinence (SUI). In addition, we compared the effectiveness of combined treatment with single treatments, single treatments with each other and single treatments with no treatment.Materials and Methods: This blinded, doubly controlled, randomized trial enrolled 201 women 18 to 75 years old with SUI at 17 incontinence centers in the Netherlands, United Kingdom and United States. Women averaged 2 or more incontinence episodes daily and were randomized to I of 4 combinations of 80 mg duloxetine daily, placebo, PFMT and imitation PFMT, including combined treatment (in 52), no active treatment (in 47), PFMT only (in 50) and duloxetine only (in 52). The primary efficacy measure was incontinence episode frequency. Other efficacy variables included the number of continence pads used and the Incontinence Quality of Life questionnaire score.Results: The intent to treat population incontinence episode frequency analysis demonstrated the superiority of duloxetine with or without PFMT compared with no treatment or with PFMT alone. However, pad and Incontinence Quality of Life analyses suggested greater improvement with combined treatment than single treatment. A completer population analysis demonstrated the efficacy of duloxetine with or without PFMT and suggested combined treatment was more effective than either treatment alone.Conclusions: The data support significant efficacy of combined PFMT and duloxetine in the treatment of women with SUI. We hypothesize that complementary modes of action of duloxetine and PFMT may result in an additive effect of combined treatment.