Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction
- Conditions
- Female Sexual Dysfunction
- Interventions
- Device: Sham procedureDevice: percutaneous tibial nerve stimulation (PTNS)
- Registration Number
- NCT04122703
- Lead Sponsor
- Stony Brook University
- Brief Summary
The purpose of this study is to understand the efficacy of PTNS versus a placebo in the treatment of female sexual dysfunction syndrome.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 66
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcutaneous electrical nerve stimulation (TENS) Sham procedure The patients in the Sham group will receive one sham (TENS) treatment per week for 12 weeks Percutaneous tibial nerve stimulation (PTNS) percutaneous tibial nerve stimulation (PTNS) The patients in the PTNS group will receive 1 PTNS treatments per week for 12 weeks.
- Primary Outcome Measures
Name Time Method Change in Female Sexual Function Index (FSFI) 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
- Secondary Outcome Measures
Name Time Method Change in Arizona Sexual Experiences Scale (ASEX) Baseline, at week 6 and at week 12 Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.
Change in Urinary Distress Inventory (UDI-6) Baseline, at week 6 and at week 12 Urinary Distress Inventory (UDI-6) is a 6-item questionnaire used to assess lower urinary tract symptoms in women. Possible total scores range from 0 to 18, with the higher scores indicating more urogenital distress.
Change in Prolapse/Urinary Incontinence Sexual-12 (PISQ-12 ) Function Questionnaire (PISQ- 12) Baseline, at week 6 and at week 12 PISQ-12 is a 12-item questionnaire used to assess sexual function in women with pelvic organ prolapse or urinary incontinence. Possible total scores range from 0 to 48, with the lower scores indicating more sexual dysfunction.
Trial Locations
- Locations (1)
Stony Brook Medicine Women's Pelvic Health And Continence Center
🇺🇸Stony Brook, New York, United States