A Pilot Study: Botulinum Toxin Type A Injections Into Pelvic Muscles for Patients With Refractory High Tone Pelvic Floor Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD.
研究概览
简要总结
This is a prospective, pilot, longitudinal study to evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD. The objective of this study is to determine the efficacy of injecting botulinum toxin type A into pelvic floor muscles that are high tone. Patients who have been diagnosed with high tone pelvic floor muscle dysfunction and have failed other treatments will be eligible to participate in this study. Study related procedures will include perineometry readings. Patients will be required to complete 7 questionnaires for this study. These include visual analog scale (scale from 0-10) for pain (VAS), the O'Leary-Sant urinary symptoms and problem questionnaires (ICSI/ICPI), Pelvic Floor Distress Inventory 20 (PFDI-20), the Female Sexual Distress Scale (FSDS), Global Response Assessment Scale and the SF-12 quality of life scale. The use of the EMG guidance is the experimental part of the study. We will perform EMG Needle testing in order to pin-point the best location for the patients Botox injections. This is a prospective, pilot, longitudinal study to evaluate the effect of Botox A injection for chronic pelvic pain and HTPFD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant must be diagnosed with High Tone Pelvic Floor Dysfunction(HTPMFD).
- •Participant must have tried and failed at least one other conventional mode of therapy for HTPMFD.
- •Participant must be a female at least 18 years of age.
- •Participant must give written informed consent to participate in this study.
- •Participant must be able to make decisions for herself.
- •Participant must not be undergoing another procedure at the time of BTX A injection.
排除标准
- •Participant is male.
- •Patient has a history of past BTX A use
- •Patient has had pelvic organ prolapse repair
- •Participant is pregnant or intends to get pregnant during the study period or is breastfeeding.
- •Participant is unwilling or unable (because of long distance from office) to follow-up.
- •Participant has a neuro-modulator device implanted.
- •Participant has a known bleeding disorder or is on anticoagulation.
- •Participant has a known hypersensitivity to BTX A.
- •Participant has a pre-existing neuromuscular disorder such as amytrophic lateral sclerosis, motor neuropathy, myasthenia gravis or Lambert-Eaton syndrome.
- •Participant with skin infection at the perineum at the site of injection.
结局指标
主要结局
To evaluate the use of EMG guidance for Botox A injection for chronic pelvic pain and HTPFD.
时间窗: 6 months
次要结局
未报告次要终点
研究者
Kristene Whitmore, M.D.
Medical Director
Pelvic and Sexual Health Institute