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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Bruns, PhD | University of Michigan | Principal Investigator |
| Mitchell Berger, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One subject enrolled in the PTNS arm did not complete the initial survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after beginning of treatment |
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Adverse event data was collected until the final survey (18 weeks after start of stimulation) was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sciatic Nerve Pain | Nervous system disorders | Non-systematic Assessment | Subject had a history of sciatic pain and aggravation reemerged during stimulation |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tim Bruns | University of Michigan | (734) 647-8727 | bruns@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2016 | Mar 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| 18 weeks after start of treatment |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Relationship Status | Count of Participants | Participants |
|
| On prescription antidepressant | Count of Participants | Participants |
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| Baseline FSFI | The Female Sexual Function Index (FSFI) 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. | Mean | Standard Deviation | score on a scale |
|
| Baseline SF-36 | The 36-Item Short Form Health Survey (SF-36) evaluates quality of life. The minimum score is 0 and the maximum score is 100, with lower scores representing lower quality of life. | Mean | Standard Deviation | units on a scale |
|
| Baseline AUASI | The 7-question American Urological Association Symptom Index (AUASI) bladder symptom index evaluates bladder functioning. Lower scores indicate better urological function. There is a minimum score of 1 and a maximum score of 35. | Mean | Standard Deviation | units on a scale |
|
| OG000 |
| 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. 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. |
| OG001 | 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. 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. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks after beginning of treatment |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 18 weeks after start of treatment |
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|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | 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. 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. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| 0.046 |
| Other |
| Other |