Treatment of Refractory Overactive Bladder (OAB) With OnabotulinumtoxinA vs. PTNS: TROOP Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Difference in patient global impression of improvement score between PTNS and BTX groups
研究概览
简要总结
This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their next treatment. OAB-dry refers to patients with OAB who do not have urge urinary incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible patients will be approached for study participation after they have decided to proceed with BTX or PTNS.
详细描述
Prior to initiation of BTX or PTNS, patients will undergo a standardized evaluation including urodynamics study (UDS) if not previously done in the past year and pelvic organ prolapse quantification (POPq) exam if not previously done in past 6 months. Subjects will also complete quality of life questionnaires and 3-day voiding diary prior to initial treatment. Follow up questionnaires will be completed at 3 months either in office, if patient has a routine visit scheduled with provider and questionnaires can be completed at that visit or questionnaires will be mailed with return postage for participant to mail completed questionnaires back.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with refractory OAB (dry or wet)
- •OAB will be defined by a positive response and bother of "somewhat, quite a bit, a great deal, or a very great deal" to question #3 or #8 on the OAB-q (see appendix B) regarding urinary urgency and urgency incontinence.
- •Refractory will be defined as failure of 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and OAB medication (anticholinergics or mirabegron). Trial of 2 medications that did not improve symptoms after 2 weeks or could not be tolerated due to side effects will constitute 2 treatment failures.
- •Women with mixed urinary incontinence that is urge predominant will also be included.
- •Age ≥ 18 years
- •English speaking
- •Available for 1 year follow-up
- •Able to complete study questionnaires
排除标准
- •Neurologic disease known to cause OAB including, but not limited to, Multiple sclerosis, Parkinson's disease, and Spinal Cord Injury.
- •Pregnancy by self-report or pregnancy test
- •Contraindication to PTNS and/or BTX
- •PTNS: Pacemaker
- •BTX: myasthenia gravis, allergy to BTX, urinary retention (post void residual >200cc)
- •Planned surgery for pelvic floor disorder during the study period
- •Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory OAB/urinary urge incontinence (UUI)
结局指标
主要结局
Difference in patient global impression of improvement score between PTNS and BTX groups
时间窗: 3 month
The Patient Global Impression of Improvement (PGI-I) is a single question that asks a patient to rate her urinary symptom response to treatment on a 7-point Likert scaleis a validated questionnaire for assessment of the impact of OAB on patient's lives.
Change in quality of life between PTNS and BTX groups
时间窗: 3 month
The minimally important difference (MID) for change in SSS is 10 points. We compare the change in SS score between the PTNS and Botox groups at 3 months.
次要结局
- Change in urinary symptom severity(3)
- Change in individual question scores on OAB-q questionnaire(3)
研究者
Robert Gutman
MD
Medstar Health Research Institute