N/A N=79 Randomized Double-blind Treatment

Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

Female Sexual Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT04122703 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Female Sexual Function Index (FSFI) — 16.72; 16.88; 22.02; 21.22 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: percutaneous tibial nerve stimulation (PTNS) (Device); Sham procedure (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Stony Brook University
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Female Sexual Function Index (FSFI)	16.72; 16.88; 22.02; 21.22; 24.29; 22.42	—

Summary

The purpose of this study is to understand the efficacy of PTNS versus a placebo in the treatment of female sexual dysfunction syndrome.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04122703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.