N/A
Completed N=79
Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction
Source: ClinicalTrials.gov NCT04122703 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Female Sexual Function Index (FSFI) — 16.72; 16.88; 22.02; 21.22 score on a scale
Summary
The purpose of this study is to understand the efficacy of PTNS versus a placebo in the treatment of female sexual dysfunction syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Female Sexual Function Index (FSFI) |
16.72; 16.88; 22.02; 21.22; 24.29; 22.42 | — |
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.
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. Informational only — not medical advice.