Surface Stimulation for Female Sexual Dysfunction

NCT02692417 | Completed Results DMC

• 1 other identifier: HUM00101713
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

hypoactive desire disorder; female sexual dysfunction; genital arousal disorder; sexual; dysfunction; female; arousal; electrical stimulation; transcutaneous electrical stimulation; women

Outcome Measures

Primary Outcomes (3)

• 6 Weeks - Total FSFI Score

  Sexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.

  6 weeks after beginning of treatment

• 12 Weeks - Total FSFI Score

  Sexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.

  12 weeks after beginning of treatment

• 18 Weeks - Total FSFI Score

  Sexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.

  18 weeks after start of treatment

Study Arms (2)

Posterior Tibial Nerve Stimulation Group

EXPERIMENTAL

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.

Device: Transcutaneous Electrical Nerve Stimulation

Dorsal Genital Nerve Stimulation Group

EXPERIMENTAL

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.

Device: Transcutaneous Electrical Nerve Stimulation

Interventions

Transcutaneous Electrical Nerve Stimulation 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; Posterior Tibial Nerve Stimulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Timothy Bruns: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Coitus

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Limitations and Caveats

There were challenges in recruitment and retention for the study. Six of the seven subjects who discontinued the study were in the PTNS arm, leading to an unequal distribution of subjects

Results Point of Contact

• Title: Dr. Tim Bruns
• Organization: University of Michigan

bruns@umich.edu

(734) 647-8727

Study Officials

• Timothy Bruns, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Mitchell Berger, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 9, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-03

Locations

US (1)