Randomized Controlled Trial of PTNS Versus Sham Efficacy in Treatment of Bladder Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2
研究概览
简要总结
This is a prospective, single center, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.
详细描述
This is a pilot study to evaluate the efficacy of the systematic effects of posterior tibial nerve stimulation (PTNS) treatment compared to an inactive sham intervention in female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) in an intent-to-treat analysis. The primary outcome measure will be the Patient Global Impression of Improvement (PGI-I) a single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint.
It is hypothesized that subjects randomized to the PTNS arm will demonstrate a greater improvement in both pain and quality of life scores, when compared with subjects who are randomized to the sham arm.
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
- Double (Participant, Investigator)
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 ≥18 years old with visual analog scale > 5
- •Cessation of all analgesics or other medication for pain for at least 2 weeks prior to the PTNS intervention
- •Discontinuation of any other electrical stimulation methods for 3 months prior to PTNS intervention.
- •Capable of giving informed consent
- •Ambulatory
- •Capable and willing to follow all study-relation procedures
排除标准
- •Patients pregnant or planning to become pregnant during the study duration
- •Botox use in pelvic floor muscles within the last year
- •Current urinary or vaginal infections
- •Current use of Interstim device
- •History of a cardiac pacemaker
- •Diagnosis of neuropathy
结局指标
主要结局
Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2
时间窗: 12 weeks
A single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint. Patients are asked to describe their condition compared to how it was before intervention on a scale from 1 to 7: Very much better = 1 Much better = 2 A little better = 3 No change = 4 A little worse = 5 Much worse = 6 Very much worse = 7
次要结局
- Visual Analog Scale (VAS)(12 Weeks)
- O'Leary-Sant Pain Scores(12 weeks)
- Over Active Bladder-Questionnaire (OAB-Q)(12 Weeks)
- The SF-12 (Short Form) Health Scale(12 Weeks)