Surface Stimulation for Female Sexual Dysfunction

Timothy Bruns

Status: Completed

Conditions: Female Sexual Dysfunction

Treatments: Device: Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02692417

HUM00101713

Details and patient eligibility

About

Female sexual dysfunction, including sexual arousal disorder, has a significant clinical impact, affecting millions of women in the United States alone. Peripheral nerve stimulation, such as posterior tibial nerve stimulation (PTNS) and dorsal genital nerve stimulation (DGNS) can modulate neural circuits for bladder and fecal continence. The investigators hypothesize that periodic DGNS and PTNS will modulate autonomic neural circuits and promote improvements in sexual function in women with sexual arousal disorder. Subjects will be randomized to receive one of the stimulation approaches. Subjects will have weekly 30-minute sessions across twelve weeks.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult women ≥ 18 years of age
• Sexually active ≥ 1 time per month (≥ 2 times per month preferred)
• Score of 19 or less on a 6-question set of the Female Sexual Function Index (FSFI) survey
• Neurologically stable
• Ambulatory
• Capable of giving informed consent
• English speaking
• Capable and willing to follow study procedures

Exclusion criteria

• Men
• Women ≤ 17 years of age
• Pregnant or planning to get pregnant during the study period
• Clinically diagnosed neurological bladder dysfunction
• Prior experience with PTNS or DGNS
• Current use of transcutaneous electrical nerve stimulation (TENS) on pelvis, back, or legs
• Implanted pacemaker, defibrillator, spinal cord stimulator, or sacral root stimulator
• Taking flibanserin
• Taking any investigational drug
• History of neurologic diseases or impairments
• Any other factors that the investigators feel would place the patient at increased risk from this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Posterior Tibial Nerve Stimulation Group

Experimental group

Description:

Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

Dorsal Genital Nerve Stimulation Group

Experimental group

Description:

Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation