University of Alabama at Birmingham, Birmingham, Alabama.
Duke University, Durham, North Carolina.
J Urol. 2017 Oct;198(4):890-896. doi: 10.1016/j.juro.2017.04.103. Epub 2017 May 10.
We sought to identify clinical and demographic characteristics associated with treatment response and satisfaction in women undergoing onabotulinumtoxinA and sacral neuromodulation therapies.
We analyzed data from the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment) trial. Baseline participant characteristics and clinical variables were associated with 2 definitions of treatment response, including 1) a reduction in mean daily urgency incontinence episodes during 6 months and 2) a 50% or greater decrease in urgency incontinence episodes across 6 months. The OAB-S (Overactive Bladder-Satisfaction) questionnaire was used to assess satisfaction.
A greater reduction in mean daily urgency incontinence episodes was associated with higher HUI-3 (Health Utility Index-3) scores in the onabotulinumtoxinA group and higher baseline incontinence episodes (each p <0.001) in the 2 groups. Increased age was associated with a lesser decrease in incontinence episodes in the 2 groups (p <0.001). Increasing body mass index (adjusted OR 0.82/5 points, 95% CI 0.70-0.96) was associated with reduced achievement of a 50% or greater decrease in incontinence episodes after each treatment. Greater age (adjusted OR 0.44/10 years, 95% CI 0.30-0.65) and a higher functional comorbidity index (adjusted OR 0.84/1 point, 95% CI 0.71-0.99) were associated with reduced achievement of a 50% or greater decrease in urgency incontinence episodes in the onabotulinumtoxinA group only (p <0.001 and 0.041, respectively). In the onabotulinumtoxinA group increased satisfaction was noted with higher HUI-3 score (p = 0.002) but there was less satisfaction with higher age (p = 0.001).
Older women with multiple comorbidities, and decreased functional and health related quality of life had decreased treatment response and satisfaction with onabotulinumtoxinA compared to sacral neuromodulation for refractory urgency incontinence.
我们旨在确定与接受肉毒毒素 A 和骶神经调节治疗的女性治疗反应和满意度相关的临床和人口统计学特征。
我们分析了 ROSETTA(难治性膀胱过度活动症:骶神经调节与肉毒毒素评估)试验的数据。基线参与者特征和临床变量与 2 种治疗反应定义相关,包括 1)6 个月期间平均每日尿急失禁发作减少,2)6 个月内尿急失禁发作减少 50%或更多。使用 OAB-S(膀胱过度活动症满意度)问卷评估满意度。
肉毒毒素 A 组中平均每日尿急失禁发作减少与更高的 HUI-3(健康效用指数-3)评分相关,两组中基线失禁发作更多(均 p<0.001)。年龄增加与两组中失禁发作减少较少相关(均 p<0.001)。随着体重指数(调整后的 OR 0.82/5 点,95%CI 0.70-0.96)的增加,与每种治疗后达到失禁发作减少 50%或更多的可能性降低相关。年龄较大(调整后的 OR 0.44/10 岁,95%CI 0.30-0.65)和功能合并症指数较高(调整后的 OR 0.84/1 分,95%CI 0.71-0.99)与肉毒毒素 A 组中达到尿急失禁发作减少 50%或更多的可能性降低相关(均 p<0.001 和 0.041)。在肉毒毒素 A 组中,更高的 HUI-3 评分与更高的满意度相关(p=0.002),但更高的年龄与较低的满意度相关(p=0.001)。
与骶神经调节相比,患有多种合并症、功能和健康相关生活质量下降的老年女性对肉毒毒素 A 的治疗反应和满意度降低,用于治疗难治性尿急失禁。