NCT01312259Unknown4 期
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Pelvic and Sexual Health Institute2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2011年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Improvement in Urinary symptoms and Bladder pain/discomfort
研究概览
简要总结
Purpose:
- To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
- The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).
详细描述
Purpose:
- Primary: to demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
- Secondary: The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with diagnosis of IC/PBS with implanted IPG Interstim.
- •Scores > 8 on the Interstitial Cystitis Symptom index questionnaire (ICSI) and > 8 on the Interstitial Cystitis Problem Index questionnaire (ICPI).
- •Signed Informed Consent.
排除标准
- •Progressive neurologic disease or peripheral neuropathy.
- •History of bladder surgery.
- •Subjects implanted with other neuromodulation device.
- •Current or planning pregnancy; Breastfeeding.
- •Subjects who are not deemed able to fill questionnaires
- •Mental illness or mentally unstable patients
结局指标
主要结局
Improvement in Urinary symptoms and Bladder pain/discomfort
时间窗: 1 year
To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
次要结局
- Improvement in Bowel symptoms and Sexual Function(1 year)
研究者
Kristene Whitmore, M.D.
Medical Director
Pelvic and Sexual Health Institute
研究点 (2)
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