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临床试验/NCT06637475
NCT06637475进行中(未招募)不适用

Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity

Selcuk University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月15日最近更新:
适应症

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

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

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 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)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra KORKUT

Asst. Prof.

Selcuk University

研究点 (1)

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