Status:
COMPLETED
Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction
Lead Sponsor:
Stony Brook University
Conditions:
Female Sexual Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
NA
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. Th...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04122703
Start Date
September 15 2019
End Date
June 30 2023
Last Update
August 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stony Brook Medicine Women's Pelvic Health And Continence Center
Stony Brook, New York, United States, 11733