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| Name | Class |
|---|---|
| International Society for the Study of Women's Sexual Health | UNKNOWN |
| The Craig H. Neilsen Foundation | OTHER |
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The researchers want to see if nerve stimulation interventions cause a change in vaginal blood flow. This intervention was performed in women who have neurogenic (spinal cord injury) or non-neurogenic sexual dysfunction and healthy women.
Two nerve stimulation locations (genital nerve and tibial nerve) were targeted with skin-surface electrical stimulation in separate experimental sessions.
This study was designed as a crossover study, but all participant data was analyzed together due to small enrollment size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibial nerve stimulation then Genital nerve stimulation | Experimental | Participants who began the study with the tibial nerve stimulation and then proceeded to genital nerve stimulation Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot |
|
| Genital nerve stimulation then Tibial nerve stimulation | Experimental | Participants who began the study with the genital nerve stimulation and then proceeded to tibial nerve stimulation Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical nerve stimulation - Tibial Nerve | Device | Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value | VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow. | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Heart Rate After Stimulation From Baseline | A heart rate monitor (e.g. electrocardiogram or pulse oximetry) will be placed on the participant's arm, hand, or chest (as is appropriate per monitor) | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
| Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline |
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Non-dysfunction participants, no spinal cord injury
Inclusion Criteria:
Exclusion Criteria:
Sexual dysfunction participants, non- spinal cord injury
Inclusion Criteria:
Exclusion Criteria:
Sexual dysfunction participants with spinal cord injury
Inclusion Criteria:
Exclusion Criteria:
Cis-gender female
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| Name | Affiliation | Role |
|---|---|---|
| Tim Bruns, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30247794 | Background | Zimmerman LL, Gupta P, O'Gara F, Langhals NB, Berger MB, Bruns TM. Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. Neuromodulation. 2018 Oct;21(7):707-713. doi: 10.1111/ner.12846. Epub 2018 Sep 3. |
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There are no plans to share IPD at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tibial nerve stimulation then Genital nerve stimulation | Participants who began the study with the tibial nerve stimulation and then proceeded to genital nerve stimulation Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot Transcutaneous electrical nerve stimulation - Tibial Nerve: Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot Transcutaneous electrical nerve stimulation - Genital Nerve: Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. |
| FG001 | Genital nerve stimulation then Tibial nerve stimulation | Participants who began the study with the genital nerve stimulation and then proceeded to tibial nerve stimulation Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. Transcutaneous electrical nerve stimulation - Tibial Nerve: Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot Transcutaneous electrical nerve stimulation - Genital Nerve: Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tibial Nerve Stimulation Then Genital Nerve Stimulation | Participants who began the study with the tibial nerve stimulation and then proceeded to genital nerve stimulation Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot Transcutaneous electrical nerve stimulation - Tibial Nerve: Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot Transcutaneous electrical nerve stimulation - Genital Nerve: Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value | VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow. | Data was analyzed for each treatment, regardless of the order in which the participant received it. One participant did not yield VPA data for either session. | Posted | Mean | Standard Deviation | Percent change | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
|
Up to 10 months
Participants were monitored for AEs during treatments and were given contact information for the study team so they could report AEs that happened after the treatments.
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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 | Tibial Nerve Stimulation | Participants received tibial nerve stimulation Transcutaneous electrical nerve stimulation (TENS) - Tibial Nerve: TENS device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | May 7, 2021 | Aug 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2021 | Aug 26, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Participants were randomized to one arm and completed the other arm 1-5 months later.
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|
| Transcutaneous electrical nerve stimulation - Genital Nerve | Device | Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. |
|
A blood pressure monitor will be placed on the participant's arm, hand, or chest (as is appropriate per monitor) to monitor off-target autonomic responses. |
| Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
| Change in Subjective Arousal After Stimulation | Subjective arousal will be evaluated by participants using a five point Likert scale, where 1 being no arousal and 5 being greatest arousal. Values are presented as the average change in arousal score after stimulation, from the baseline measures. | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
| Withdrawal by Subject |
|
| BG001 | Genital Nerve Stimulation Then Tibial Nerve Stimulation | Participants who began the study with the genital nerve stimulation and then proceeded to tibial nerve stimulation Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. Transcutaneous electrical nerve stimulation - Tibial Nerve: Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot Transcutaneous electrical nerve stimulation - Genital Nerve: Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Vaginal Pulse Amplitude (VPA) | While this is shown here in the two arms, data from all participants was analyzed together, regardless of arm. VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow. | One participant did not yield VPA data for either session. Participants who did not complete a stimulation session did not have a baseline VPA value for the session that they missed. | Mean | Standard Deviation | mV |
|
| Baseline Heart Rate | Participants who did not complete study did not have a baseline measure for the stimulation session that they missed. | Mean | Standard Deviation | bpm |
|
| Baseline Mean Arterial Pressure | Participants who did not complete both sessions did not have a baseline value for the stimulation session that they missed. | Mean | Standard Deviation | mmHg |
|
| Baseline Arousal Score | Subjective arousal was evaluated by participants using a five point Likert scale, where 1 being no arousal and 5 being greatest arousal. | Participants who did not complete both sessions did not have a baseline score for the stimulation session that they missed. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Genital Nerve Stimulation | Participants received genital nerve stimulation Transcutaneous electrical nerve stimulation (TENS) - Genital Nerve: TENS device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. |
|
|
| Secondary | Percent Change in Heart Rate After Stimulation From Baseline | A heart rate monitor (e.g. electrocardiogram or pulse oximetry) will be placed on the participant's arm, hand, or chest (as is appropriate per monitor) | Data was analyzed for each treatment, regardless of the order in which the participant received it. | Posted | Mean | Standard Deviation | percent change | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
|
|
|
| Secondary | Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline | A blood pressure monitor will be placed on the participant's arm, hand, or chest (as is appropriate per monitor) to monitor off-target autonomic responses. | Data was analyzed for each treatment, regardless of the order in which the participant received it. | Posted | Mean | Standard Deviation | percent change | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
|
|
|
| Secondary | Change in Subjective Arousal After Stimulation | Subjective arousal will be evaluated by participants using a five point Likert scale, where 1 being no arousal and 5 being greatest arousal. Values are presented as the average change in arousal score after stimulation, from the baseline measures. | Data was analyzed for each treatment, regardless of the order in which the participant received it. | Posted | Mean | Standard Deviation | score on a scale | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Genital Nerve Stimulation | Participants received genital nerve stimulation Transcutaneous electrical nerve stimulation (TENS) - Genital Nerve: TENS device (Empi Select 199584, Medi-Stim Inc.) Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D014947 | Wounds and Injuries |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|