Surface Stimulation for Female Sexual Dysfunction

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.

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Key information

Conditions

Female Sexual Dysfunction Behavior Coitus Sexual Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

6 Weeks - Total FSFI Score

Time frame: 6 weeks after beginning of treatment

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 - Total FSFI Score

Time frame: 12 weeks after beginning of treatment

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 - Total FSFI Score

Time frame: 18 weeks after start of treatment

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.

Sponsors and collaborators

Lead sponsor

Timothy Bruns

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Feb 26, 2016
Registry last updated: Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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