A Randomized Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not
研究概览
简要总结
This study has 2 parts. Part 1 is a 12-week observational study of weekly Posterior Tibial Nerve Stimulation (PTNS) treatment for women with overactive bladder. Part 2 is a randomized, controlled trial of monthly maintenance PTNS therapy versus no therapy in subjects who were successfully treated by PTNS in Part 1.
Part 1: 12-week observational study of weekly PTNS treatment.
The primary aim of Part 1 is to determine the efficacy of a 12-week course of PTNS in the treatment of overactive bladder. Secondary aims are to determine the changes in voiding frequency and quality-of-life measures after the 12-week treatment.
Part 2: Randomized, controlled study of monthly PTNS compared to no PTNS after 12-week treatment
The primary aim is to determine time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not, in order to ascertain if there is a need for maintenance therapy after 12 weeks of PTNS. The investigators' secondary aims are to compare the long-term efficacy and quality of life impact in patient receiving maintenance PTNS compared to those that do not and to determine the efficacy of rescue maintenance PTNS in subjects who have symptom recurrence in the no maintenance therapy arm.
Hypothesis: There will be no difference in time to failure between women randomized to monthly maintenance PTNS compared to no maintenance PTNS.
详细描述
This study has two parts: an observational study of PTNS (Part 1) and a randomized, controlled trial of maintenance PTNS compared to no maintenance PTNS (Part 2).
Part 1: This is an observational study of the efficacy of PTNS therapy in women with bothersome OAB symptoms who have failed anticholinergic therapy. Subjects will be offered a standardized weekly regimen of PTNS for 12 weeks and asked to respond to surveys before and after treatment.
Pre- and post- intervention assessments will include a 3-day diary to assess voiding volume and frequency, Pelvic Floor Impact Questionnaire, Short Form Health Survey (SF-12), Patient Global Impression of Severity (PGI-S), Overactive Bladder Questionnaire (OAB-q short form bother),and the Pelvic Floor Distress Inventory Short Form (Urogenital Distress Inventory UDI 6 subset). Post-intervention assessment will include the above, as well as the Patient Global Impression of Improvement (PGI-I).
Part 2: After the initial 12-week treatment, all women with PGI-I less than 4, defined as patient perception of bladder function as better, much better, or very much better after the treatment than before the treatment, will be randomized to monthly PTNS or no PTNS. Part 2 of the study will continue for an additional 42 weeks (i.e. 52 weeks total in parts 1 and 2). Subjects will be considered to have failed therapy if their PGI-I score is greater than 3. If they are currently receiving PTNS maintenance therapy and have a PGI-I score greater than 3, they will be withdrawn from the study and transferred to clinical care to pursue other treatment options.
If they are in the no maintenance arm and have a PGI-I score greater than 3, then they are considered to have failed the no-maintenance treatment arm and may receive monthly PTNS treatment or pursue other treatment if they choose .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 overactive bladder syndrome referred to UCSD Women's Pelvic Medicine Center by treating physician for PTNS therapy as standard of care
- •At least 18 years old
- •9 or more voids per 24 hours
- •PGI - S score of "moderate" or "great" bother
- •If on anticholinergic medication, they must be on stable dose of medications for at least one month
- •Able to provide informed consent and complete study measures
排除标准
- •Postvoid residual > 150 ml to exclude subjects with urinary retention
- •Active urinary tract infection (defer entry until resolved)
- •Urine output > 2800 ml per day
- •Diagnosis of interstitial cystitis or chronic pelvic pain
- •Diagnosis of bladder cancer
- •Currently pregnant
研究组 & 干预措施
Monthly Maintenance PTNS
After 12 weeks of PTNS, patients will be randomized to either the monthly PTNS arm, or the no maintenance PTNS arm.
干预措施: PTNS (Procedure)
No maintenance PTNS
After 12 weeks of PTNS, patients will either be randomized to the Monthly PTNS arm or the No maintenance PTNS arm.
结局指标
主要结局
time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not
时间窗: 40 weeks
次要结局
- efficacy of a 12-week course of PTNS in the treatment of overactive bladder(12 weeks)