Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

Stony Brook University

Status: Completed

Conditions: Female Sexual Dysfunction

Treatments: Device: percutaneous tibial nerve stimulation (PTNS); Device: Sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04122703

1370654

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Percutaneous tibial nerve stimulation (PTNS)

Experimental group

Description:

The patients in the PTNS group will receive 1 PTNS treatments per week for 12 weeks.

Treatment:

Device: percutaneous tibial nerve stimulation (PTNS)

Transcutaneous electrical nerve stimulation (TENS)

Sham Comparator group

Description:

The patients in the Sham group will receive one sham (TENS) treatment per week for 12 weeks

Treatment:

Device: Sham procedure