Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

NACompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

September 15, 2019

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2023

Conditions
Female Sexual Dysfunction
Interventions
DEVICE

percutaneous tibial nerve stimulation (PTNS)

The PTNS treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.

DEVICE

Sham procedure

The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation

Trial Locations (1)

11733

Stony Brook Medicine Women's Pelvic Health And Continence Center, Stony Brook

All Listed Sponsors
lead

Stony Brook University

OTHER

NCT04122703 - Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction | Biotech Hunter | Biotech Hunter