Surface Stimulation for Female Sexual Dysfunction

NCT ID: NCT02692417

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-03-31

Brief Summary

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.

Conditions

Female Sexual Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Posterior Tibial Nerve Stimulation Group

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.

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.

Dorsal Genital Nerve Stimulation Group

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.

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.

Interventions

Transcutaneous Electrical Nerve Stimulation

Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Timothy Bruns

OTHER

Sponsor Role: lead

Responsible Party

Timothy Bruns

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Timothy Bruns, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Mitchell Berger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00101713

Identifier Type: -

Identifier Source: org_study_id