Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
研究概览
简要总结
The aim of this study was to investigate the effects of external electrical stimulation on clinical symptoms such as vaginal symptoms, pelvic floor symptoms, sexual function, pelvic floor muscle morphometry (levator ani thickness) and functions (strength, endurance), vaginal wall thickness and perception of healing in women with vaginal laxity.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Complaining of vaginal laxity To be between 18-60 years old, Being sexually active, Volunteering to participate in the study, Becoming literate -
排除标准
- •Sensory loss Presence of infection Having a pacemaker Metal implant presence Malignancy story Having serious cardiovascular problems Presence of severe pelvic organ prolapse (above stage 2) Having undergone surgery for POP/incontinence (within the last 1 year) Pregnancy presence Having enough laxity to require surgery Having a neurological disorder Receiving estrogen therapy
研究组 & 干预措施
electric stimulation group
Individuals who meet the inclusion criteria and who have signed the consent form will be randomly divided into 2 groups (treatment and control groups). Randomization will be done by a researcher who is not involved in the study using computer-assisted randomization blocks. The treatment group patients will receive 3 sessions of external stimulation per week for 8 weeks, while the control group will not receive any intervention (consisting of patients waiting on the treatment list).
干预措施: Electric stimulation (Device)
control group
结局指标
主要结局
Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
时间窗: Change from basline at 8 weeks
次要结局
- Pelvic floor muscle morphometry (levator ani thickness)(Change from baseline at 8 weeks)
- Pelvic floor muscle strength and endurance(Change from baseline at 8 weeks)
- Vaginal wall and mucosa thickness(Change from basline at 8 weeks)
- Pelvic floor symptoms Pelvic Floor Distress Inventory-20 (PTDE-20)(Change from basline at 8 weeks)
- Sexual function Female Sexual Function Index (FSFI)(Change from baseline at 8 weeks)
研究者
Zehra KORKUT
Asst. Prof.
Selcuk University