Surface Stimulation for Female Sexual Dysfunction

Female Sexual Dysfunction Clinical Trial

Official title:

Surface Stimulation for Female Sexual Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692417
• Other study ID #: HUM00101713
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Timothy Bruns

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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