Female Sexual DysfunctionNCT02692417

Surface Stimulation for Female Sexual Dysfunction

A study testing Transcutaneous Electrical Nerve Stimulation in people with Female Sexual Dysfunction, run by Timothy Bruns at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Female Sexual Dysfunction
What is being tested?: Transcutaneous Electrical Nerve Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Feb 2016to Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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 locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Health System
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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
Being tested: Transcutaneous Electrical Nerve Stimulation
Keywords: hypoactive desire disorder, female sexual dysfunction, genital arousal disorder, sexual, dysfunction, female, arousal, electrical stimulation, transcutaneous electrical stimulation, women
Medical subject headings: Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Electrical Nerve StimulationDevice
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.

Study groups in NCT02692417
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 18 weeks after start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Mar 2018

First posted26 Feb 2016 (estimated)
Study startFeb 2016
Primary completionMar 2018
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02692417
Sponsor's protocol ID: HUM00101713
Status last verified: Mar 2019
First submitted: 23 Feb 2016
Last updated: 9 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Female Sexual Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surface Stimulation for Female Sexual Dysfunction
ClinicalTrials.gov ID: NCT02692417
Acronym / sponsor ID: HUM00101713
Conditions: Female Sexual Dysfunction
Keywords: hypoactive desire disorder, female sexual dysfunction, genital arousal disorder, sexual, dysfunction, female, arousal, electrical stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Timothy BrunsUniversity, hospital or other
Study start: Feb 2016
Primary completion: Mar 2018 (actual)
Study completion: Mar 2018 (actual)
First posted: 26 Feb 2016 (estimated)
Results: Posted 9 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Posterior Tibial Nerve Stimulation Group	Experimental	Device: Transcutaneous Electrical Nerve StimulationSubjects 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.
Dorsal Genital Nerve Stimulation Group	Experimental	Device: Transcutaneous Electrical Nerve StimulationSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcutaneous Electrical Nerve StimulationBoth 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.	Device	Dorsal Genital Nerve Stimulation Group, Posterior Tibial Nerve Stimulation Group

Primary outcome

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.

Results and safety

Results posted to the registry on 9 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Posterior Tibial Nerve Stimulation Group	9	3
Dorsal Genital Nerve Stimulation Group	7	6

Primary outcome: 6 Weeks - Total FSFI Score

Time frame: 6 weeks after beginning of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Posterior Tibial Nerve Stimulation Group n = 3	Dorsal Genital Nerve Stimulation Group n = 6
Value	26.0 (7.8)	17.4 (6.6)

Posterior Tibial Nerve Stimulation Group: p = 0.109, Wilcoxon (Mann-Whitney)
Dorsal Genital Nerve Stimulation Group: p = 0.225, Wilcoxon (Mann-Whitney)

Primary outcome: 12 Weeks - Total FSFI Score

Time frame: 12 weeks after beginning of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Posterior Tibial Nerve Stimulation Group n = 3	Dorsal Genital Nerve Stimulation Group n = 6
Value	27.8 (4.8)	18.7 (6.9)

Posterior Tibial Nerve Stimulation Group: p = 0.109, Wilcoxon (Mann-Whitney)
Dorsal Genital Nerve Stimulation Group: p = 0.046, Wilcoxon (Mann-Whitney)

Primary outcome: 18 Weeks - Total FSFI Score

Time frame: 18 weeks after start of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Posterior Tibial Nerve Stimulation Group n = 3	Dorsal Genital Nerve Stimulation Group n = 6
Value	26.2 (8.6)	18.8 (5.4)

Posterior Tibial Nerve Stimulation Group: p = 0.109, Wilcoxon (Mann-Whitney)
Dorsal Genital Nerve Stimulation Group: p = 0.028, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: Adverse event data was collected until the final survey (18 weeks after start of stimulation) was collected.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Posterior Tibial Nerve Stimulation Group	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
Dorsal Genital Nerve Stimulation Group	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy Bruns, PhD principal investigator

University of Michigan

Mitchell Berger, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Electrical Nerve Stimulation in people with Female Sexual Dysfunction, run by Timothy Bruns at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Weeks - Total FSFI Score (time frame: 6 weeks after beginning of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02692417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.