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Surface Stimulation for Female Sexual Dysfunction

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ClinicalTrials.gov Identifier: NCT02692417
Recruitment Status : Completed
First Posted : February 26, 2016
Results First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Timothy Bruns, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Female Sexual Dysfunction Device: Transcutaneous Electrical Nerve Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surface Stimulation for Female Sexual Dysfunction
Study Start Date : February 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: 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.
Device: 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.

Experimental: 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.
Device: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692417


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Timothy Bruns
Investigators
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Principal Investigator: Timothy Bruns, PhD University of Michigan
Principal Investigator: Mitchell Berger, MD University of Michigan
  Study Documents (Full-Text)

Documents provided by Timothy Bruns, University of Michigan:
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Responsible Party: Timothy Bruns, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02692417    
Other Study ID Numbers: HUM00101713
First Posted: February 26, 2016    Key Record Dates
Results First Posted: April 9, 2019
Last Update Posted: April 9, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Timothy Bruns, University of Michigan:
hypoactive desire disorder
female sexual dysfunction
genital arousal disorder
sexual
dysfunction
female
arousal
electrical stimulation
transcutaneous electrical stimulation
women