NCT05529407Unknown不适用
Trial of Simple Vaginal Tampons vs Glass Vaginal Dilators in Treatment of Genitopelvic Penetration Disorder
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Sucessfull Intercourse-Diary
研究概览
简要总结
The aim of this study is to compare the success rates of vaginismus therapy using a tampon or a dilator during exposure
详细描述
Tampon Group
Exercises will be performed with tampon
Dilator Group
Exercises wil be performed with dilator
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •non-pregnant/non lactating women aged between 18-50
- •diagnosed with primary vaginismus of Lamont level II or higher
排除标准
- •hymenal abnormalities, congenital vaginal abnormalities, vulvodynia, secondary vaginismus following physical or psychological trauma, infection, menopausal period or pelvic pathology and with any psychiatric or physiological disease.
- •Patients with husbands possessing a history of sexual dysfunction (erectile dysfunction or premature ejaculation, for example)
结局指标
主要结局
Sucessfull Intercourse-Diary
时间窗: 30 days
3 point scale: 1-did not try. 2- try but unseccesfull. 3- successfull intercourse
次要结局
- GRISS: Golombuk Rust Inventory of Sexual Satisfaction(30 day)
- FSFI Score(30 day)
- Fear of Coitus Subscale(30 day)
研究者
Ayşe Filiz Gökmen Karasu
Doctor
Bezmialem Vakif University
研究点 (2)
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