NCT06677541招募中不适用
Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Female Sexual Function Index
研究概览
简要总结
Limited data exist describing the use and role of vibrators in a urogynecology population and no randomized controlled trials investigating the use of vibrators as a therapeutic tool to enhance sexual and pelvic floor function in urogynecology patients has been conducted. This study aims to evaluate the efficacy of vibrator use in improving sexual and pelvic floor function in urogynecology patients who report sexual dysfunction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Women aged 18 and over presenting to the urogynecology clinic.
- •Women diagnosed with one of the following urogynecologic conditions
- •o Pelvic organ prolapse, urgency incontinence, overactive bladder, stress urinary incontinence, fecal incontinence, recovering from a urogynecologic surgery over 6 weeks following surgery and clear for intercourse. Patients post op who continue to have pelvic floor dysfunction can be candidates for the study if they continue to have one of the pelvic floor dysfunctions listed.
- •Patient will be screened with the FSFI and will be eligible if they score less than 26.55
- •Patient's must be willing to use a vibrator.
- •Able to provide informed consent.
- •Not currently using a vibrator or has not used a vibrator in the past 3 months.
- •Able to read and write in English
排除标准
- •• Patients with cognitive impairment.
- •Patients with refusal or discomfort with vibrator use.
- •Currently using a vibrator or has used a vibrator in the past 3 months.
- •Patients unable to provide informed consent.
- •Patients not clear for intercourse following their surgery
- •Patients with surgery within 2 months of recruitment.
结局指标
主要结局
Female Sexual Function Index
时间窗: up to 12 weeks
A 19 question validated survey on sexual function with lower scores indicating worse outcome
次要结局
- Pelvic Floor Distress Inventory -20(up to 12 weeks)
- Pelvic Organ Prolapse incontinence sexual questionnaire 12(up to 12 weeks)
- sexual satisfaction index(up to 12 weeks)
- female genitourinary pain index(up to 12 weeks)
- patient health questionnaire 9(up to 12 weeks)
研究者
研究点 (2)
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