Surface Stimulation for Female Sexual Dysfunction

• Sponsor: Timothy Bruns (Other)
• Overall Status: Completed
• CT.gov ID: NCT02692417
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 24.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Feb 1, 2016
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 6 Weeks - Total FSFI Score [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Health System	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• Timothy Bruns

Investigators

• Principal Investigator: Timothy Bruns, PhD, University of Michigan
• Principal Investigator: Mitchell Berger, MD, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 15, 2016

More Information

Publications

None provided.

• Responsible Party: Timothy Bruns, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT02692417
• Other Study ID Numbers: HUM00101713
• First Posted: Feb 26, 2016
• Last Update Posted: Apr 9, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Timothy Bruns, Assistant Professor, University of Michigan: hypoactive desire disorder; female sexual dysfunction; genital arousal disorder; sexual; dysfunction; female; arousal; electrical stimulation; transcutaneous electrical stimulation; women

Study Results

Participant Flow

Arm/Group Title	Posterior Tibial Nerve Stimulation Group	Dorsal Genital Nerve Stimulation Group
Arm/Group Description	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. 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.	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. 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.
Period Title: Overall Study
STARTED	9	7
COMPLETED	3	6
NOT COMPLETED	6	1

Baseline Characteristics

Arm/Group Title	Posterior Tibial Nerve Stimulation Group	Dorsal Genital Nerve Stimulation Group	Total
Arm/Group Description	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. 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.	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. 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.	Total of all reporting groups
Overall Participants	8	7	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.0 (14.3)	46.6 (14.8)	40.9 (15.0)
Sex: Female, Male (Count of Participants)
Female	8 100%	7 100%	15 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	4 50%	6 85.7%	10 66.7%
Black	1 12.5%	0 0%	1 6.7%
Asian or Pacific Islander	0 0%	1 14.3%	1 6.7%
Other	3 37.5%	0 0%	3 20%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.1 (4.5)	26.5 (4.5)	26.8 (4.4)
Relationship Status (Count of Participants)
Single	1 12.5%	1 14.3%	2 13.3%
Nonmarried relationship	2 25%	1 14.3%	3 20%
Married	5 62.5%	5 71.4%	10 66.7%
On prescription antidepressant (Count of Participants)
Count of Participants [Participants]	3 37.5%	3 42.9%	6 40%
Baseline FSFI (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	18.4 (5.1)	16.0 (5.3)	17.3 (5.2)
Baseline SF-36 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	78.8 (15.3)	87.4 (4.2)	82.8 (12.0)
Baseline AUASI (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.6 (6.4)	4.6 (2.6)	6.7 (5.3)

Outcome Measures

1. Primary Outcome

Title	6 Weeks - Total FSFI Score
Description	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.
Time Frame	6 weeks after beginning of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Posterior Tibial Nerve Stimulation Group	Dorsal Genital Nerve Stimulation Group
Arm/Group Description	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. 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.	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. 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.
Measure Participants	3	6
Mean (Standard Deviation) [score on a scale]	26.0 (7.8)	17.4 (6.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Posterior Tibial Nerve Stimulation Group
	Comments	Wilcoxon signed rank test comparing FSFI score from baseline to time point.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.109
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dorsal Genital Nerve Stimulation Group
	Comments	Wilcoxon signed rank test comparing FSFI score from baseline to time point.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.225
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	12 Weeks - Total FSFI Score
Description	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.
Time Frame	12 weeks after beginning of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Posterior Tibial Nerve Stimulation Group	Dorsal Genital Nerve Stimulation Group
Arm/Group Description	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. 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.	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. 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.
Measure Participants	3	6
Mean (Standard Deviation) [score on a scale]	27.8 (4.8)	18.7 (6.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Posterior Tibial Nerve Stimulation Group
	Comments	Wilcoxon signed rank test comparing FSFI score from baseline to time point.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.109
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dorsal Genital Nerve Stimulation Group
	Comments	Wilcoxon signed rank test comparing FSFI score from baseline to time point.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	18 Weeks - Total FSFI Score
Description	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.
Time Frame	18 weeks after start of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Posterior Tibial Nerve Stimulation Group	Dorsal Genital Nerve Stimulation Group
Arm/Group Description	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. 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.	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. 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.
Measure Participants	3	6
Mean (Standard Deviation) [score on a scale]	26.2 (8.6)	18.8 (5.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Posterior Tibial Nerve Stimulation Group
	Comments	Wilcoxon signed rank test comparing FSFI score from baseline to time point.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.109
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dorsal Genital Nerve Stimulation Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse event data was collected until the final survey (18 weeks after start of stimulation) was collected.
Arm/Group Title	Posterior Tibial Nerve Stimulation Group		Dorsal Genital Nerve Stimulation Group
Arm/Group Description	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. 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.		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. 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.
All Cause Mortality
	Posterior Tibial Nerve Stimulation Group		Dorsal Genital Nerve Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/7 (0%)
Serious Adverse Events
	Posterior Tibial Nerve Stimulation Group		Dorsal Genital Nerve Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Posterior Tibial Nerve Stimulation Group		Dorsal Genital Nerve Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		0/7 (0%)
Nervous system disorders
Sciatic Nerve Pain	1/9 (11.1%)	1	0/7 (0%)	0

Limitations/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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.