Randomized Controlled Trial for Use of Low Intensity Shockwave for Patients With Dyspareunia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Numerical pain rating scale for tampon test
研究概览
简要总结
Dyspareunia is defined as a complaint of persistent or recurring pain or discomfort associated with attempted or complete vaginal penetration
e purpose of this study is to determine the effectiveness of low intensity shockwave treatment for patients with dyspareunia and their ability to tolerate sexual activity, (i.e., penetration of vagina, self or partnered pleasure).
Participants will:
- Be given a preliminary physical therapy examination and evaluation.
- Be asked to attend weekly low intensity shockwave treatment visits.
- Be asked to complete 3 Month follow up questionnaires
详细描述
This study seeks to determine the effectiveness of low intensity shockwave (LiSWT) for patients with dyspareunia, with the primary objective being the ability to tolerate penetration of the vagina and sexual activity, (self or partnered pleasure). A secondary objective of the study is an improved quality of life.
This is a single blind, randomized controlled trial, with randomized placebo phase design.
A total of 60 participants enrolled at 4 clinical sites will be blinded to the group they are assigned to, (treatment or sham). Clinical investigators cannot be blinded to treatment or sham in order to deliver the treatment.
There are two arms of the study: the Intervention arm where subjects receive active low intensity shockwave treatment plus typical physical therapy. Intervention is the delivery of shockwaves to the pelvic floor region using Softwave Tissue RegenerationTechnologies OrthoGold 100 MTS OP155 unfocused parabolic probe electrohydraulic device.
The Control arm subjects receive sham shockwave treatment plus typical physical therapy.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary diagnosis of dyspareunia (pain with intercourse and/or vaginal penetration)
- •Cisgender female or have natal vaginal tissu
- •Has not started hormonal therapy within the past 2 weeks
- •Has not received pelvic floor physical therapy within the past 2 weeks
- •Is able to electronically access informed consent and outcomes measures forms
排除标准
- •Have a diagnosis of lichen sclerosis
- •Have an active infection (e.g. herpes)
- •Are earlier than 12 weeks post-surgery
- •Are earlier than 6 weeks postpartum
- •Have a history of gynecological cancer
- •Have a history of pelvic radiation
- •Are actively undergoing cancer treatments
- •Are currently pregnant
- •Currently using lidocaine or cortisone
结局指标
主要结局
Numerical pain rating scale for tampon test
时间窗: up to 6 weeks
A self-reported measurement of pain on a numeric scale from 1 to 10, with 0 signifying no pain and 10 signifying extreme pain.
Female Sexual Function Index, (FSFI)
时间窗: up to 6 weeks
A validated, self-reported questionnaire assessing different domains of female sexual function including desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2.0 to 36.0. Lower scores indicate greater risk of female sexual dysfunction, and higher scores indicate better outcomes in overall sexual function.
Tampon Test
时间窗: up to 6 weeks
A self-reported measurement of pain on a numeric scale from 0 to 10, with 0 signifying no pain and 10 signifying extreme pain.
次要结局
- Beck Depression Scale(Completed once per week for 4 to 6 weeks)
- Numeric pain score for deep penetration.(Completed once per week for 4 to 6 weeks)