Clinical Trial

Tibial Nerve Stimulation for Treating Sexual Dysfunction

Study Description

Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

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

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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 ...read more on ClinicalTrials.org

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 tw ...read more on ClinicalTrials.org

Additional Information

Official Study Title

A Randomized Controlled Trial Investigating the Efficacy of Percutaneous Tibial Nerve Stimulation (PTNS) in the Treatment of Female Sexual Dysfunction (FSD)

Clinical Trial ID

NCT04122703

ParticipAid ID

bYEKKb