A Randomized Controlled Trial Investigating the Efficacy of Percutaneous Tibial Nerve Stimulation (PTNS) in the Treatment of Female Sexual Dysfunction (FSD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Change in Female Sexual Function Index (FSFI)
研究概览
简要总结
The purpose of this study is to understand the efficacy of PTNS versus a placebo in the treatment of female sexual dysfunction syndrome.
详细描述
The goal of this study is to evaluate the efficacy of PTNS in treating patients with FSD. We will be recruiting 66 patients, who will be randomized (1:1) to either the PTNS group or the Sham group. The patients in the PTNS group will receive one PTNS treatment per week for 12 weeks. The patients in the Sham group will receive one sham treatment per week for 12 weeks. Patients in both groups will be asked to complete questionnaires before the start of the treatment, as well as after 12-weeks of treatment to assess the changes in the severity of their symptoms
Aim 1: To evaluate the effect of percutaneous tibial nerve stimulation (PTNS), compared to a validated sham, on sexual functioning in women with female sexual dysfunction (FSD).
Aim 2: To compare the effect of PTNS on lower urinary tract symptoms versus sexual functioning in patient with FSD.
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
- Double (Participant, Care Provider)
盲法说明
Patients in both PTNS and Sham groups will come to the clinic once a week for 30 sessions, and will not know their group assignment until the end of the study.
All the interventions will be performed by the sub-investigator. The care providing physician will not know the group assignment of the patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 or older
- •FSFI score of ≤ 26.55
- •Patients must be sexually active within one month prior to the study and plans to continue to be sexually active for the next 12 weeks (Sexual activity can include masturbating, vaginal intercourse, caressing, and foreplay)
排除标准
- •Patients with anatomical limitations preventing successful placement of the electrode (bleeding disorders, peripheral vascular disease, ulcers, or lower leg cellulitis)
- •Patients with medical disorders precluding stimulation (cardiac pacemakers, current use of Holter monitor, known history of neuropathy)
- •Pregnant women or women intending to become pregnant during the course of the study.
研究组 & 干预措施
Percutaneous tibial nerve stimulation (PTNS)
The patients in the PTNS group will receive 1 PTNS treatments per week for 12 weeks.
干预措施: percutaneous tibial nerve stimulation (PTNS) (Device)
Transcutaneous electrical nerve stimulation (TENS)
The patients in the Sham group will receive one sham (TENS) treatment per week for 12 weeks
干预措施: Sham procedure (Device)
结局指标
主要结局
Change in Female Sexual Function Index (FSFI)
时间窗: Baseline, at week 6 and at week 12
Female Sexual Function Index (FSFI) is a 19-item questionnaire used to assess female sexual function. Minimum score is 1.2 and maximum score is 36. A score of 26.55 or lower is classified as sexual dysfunction
次要结局
- Change in Arizona Sexual Experiences Scale (ASEX)(Baseline, at week 6 and at week 12)
- Change in Urinary Distress Inventory (UDI-6)(Baseline, at week 6 and at week 12)
- Change in Prolapse/Urinary Incontinence Sexual-12 (PISQ-12 ) Function Questionnaire (PISQ- 12)(Baseline, at week 6 and at week 12)
研究者
Jason Kim
Clinical Assistant Professor of Urology
Stony Brook University