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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 overall purpose of this research is to improve sexual function in women with sexual dysfunction. The goal of this study is to see if either of two nerve stimulation interventions cause a short-term change in vaginal blood flow. The effect of this intervention will be compared between women who have neurogenic (spinal cord injury) or non-neurogenic dysfunction and healthy women, to reveal mechanisms underlying neural control over vaginal blood flow.
This study will explore the short-term effect of tibial and genital stimulation on vaginal blood flow in healthy women, non-neurogenic women with female sexual dysfunction (FSD), and women with both FSD and spinal cord injuries (SCI). To potentially amplify any stimulation effects, this study will incorporate the use of sexually explicit films, a method that is standard in sexual function studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibial nerve stimulation, then genital nerve stimulation | Experimental | Participants in this arm received tibial nerve stimulation during their first study visit. Those who returned for the second study visit then received genital nerve stimulation. Film Clip Alternation will take place during both interventions. |
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| Genital nerve stimulation, then tibial nerve stimulation | Experimental | Participants in this arm received genital nerve stimulation during their first study visit. Those who returned for the second study visit then received tibial nerve stimulation. Film Clip Alternation will take place during both interventions. |
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| 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 |
|---|---|---|
| Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | VPA will be measured by a vaginal plethysmography transducer that is placed in the vagina to measure changes in blood flow during the full study session. Overall treatment sequence: baseline (nature) video erotic video 1 (no treatment = "control") baseline nature video (treatment on in middle) erotic video 2 (treatment) The average VPA value during the baseline period will be determined. The maximum percent change in VPA during each relevant sequence as compared to the average baseline VPA will be determined for each participant. | Up to five months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Heart Rate 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) to measure the heart rate in beats per minute (bpm). The average heart rate in bpm during the baseline video will be determined. The average percent change in heart rate during each test sequence as compared to the average baseline heart rate will be determined. |
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Inclusion Criteria:
All Participants
Non-dysfunction participants
Non-SCI dysfunction participants
Spinal cord injured participants
Exclusion Criteria:
Non-dysfunction participants:
Non-SCI dysfunction participants:
Spinal cord injured participants:
Only cisgendered females were eligible for this study
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| Name | Affiliation | Role |
|---|---|---|
| Tim Bruns, Ph.D | University of Michigan | Principal Investigator |
| Priyanka Gupta, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tibial Nerve Stimulation, Then Genital Nerve Stimulation | Participants in this arm received tibial nerve stimulation during their first study visit. Those who returned for the second study visit then received genital nerve stimulation. Film Clip Alternation will take place during both interventions. 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 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. Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 26, 2023 |
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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. |
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| Neutral and Erotic Film Clip Alternation | Behavioral | During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. Physiological arousal will be assessed with a vaginal photoplethysmography probe, yielding vaginal pulse amplitude (VPA) for analysis. Subjective arousal will be assessed with a subjective arousal questionnaire. |
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| Up to five months |
| Percent Change in Mean Arterial Blood Pressure 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. The mean arterial blood pressure in millimeters of mercury (mm Hg) will be calculated for a period as the diastolic pressure plus 1/3 times the difference between the systolic pressure and the diastolic pressure, following standard practice. The average mean arterial blood pressure will be determined for the baseline period. The percent change in average mean arterial blood pressure with respect to the baseline period will be determined for each test sequence. | Up to five months |
| Change in Subjective Arousal From Baseline | Subjective arousal will be evaluated by participants using a five point Likert scale, where 1 being no arousal and 5 being greatest arousal. Survey will be presented to patients between every video transition (a total of 4 times). Data is presented as averages per video transition point. | Up to five months |
| FG001 | Genital Nerve Stimulation, Then Tibial Nerve Stimulation | Participants in this arm received genital nerve stimulation during their first study visit. Those who returned for the second study visit then received tibial nerve stimulation. Film Clip Alternation will take place during both interventions. 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 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. Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. |
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| COMPLETED | Second treatment option (opposite from first) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tibial Nerve Stimulation, Then Genital Nerve Stimulation | Participants in this arm received tibial nerve stimulation during their first study visit. Those who returned for the second study visit then received genital nerve stimulation. Film Clip Alternation will take place during both interventions. 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 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. Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. |
| BG001 | Genital Nerve Stimulation, Then Tibial Nerve Stimulation | Participants in this arm received genital nerve stimulation during their first study visit. Those who returned for the second study visit then received tibial nerve stimulation. Film Clip Alternation will take place during both interventions. 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 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. Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline Vaginal Pulse Amplitude (VPA) | Vaginal Pulse Amplitude (VPA) is measured with a vaginal photoplethysmograph probe, which provides a measure of local blood flow in a relative scale using mV. The baseline VPA measure for each participant was determined as the mean VPA during the baseline period. The Outcome measure was calculated as mean baseline of the total participants, regardless of which order they were administered the treatment. One participant in the Tibial Nerve First arm did not receive the Genital Nerve treatment. One participant in the Genital Nerve First arm did not receive the Tibial Nerve treatment. | Measure Description: Outcome measure was calculated as baseline of the total participants, regardless of which order they were administered the treatment. One participant in the Tibial Nerve First arm did not receive the Genital Nerve treatment. One participant in the Genital Nerve First arm did not receive the Tibial Nerve treatment. | Mean | Standard Deviation | mV |
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| Baseline Heart Rate | Outcome measure was calculated as baseline of the total participants, regardless of which order they were administered the treatment. One participant in the Tibial Nerve First arm did not receive the Genital Nerve treatment. One participant in the Genital Nerve First arm did not receive the Tibial Nerve treatment. | Measure Description: Outcome measure was calculated as baseline of the total participants, regardless of which order they were administered the treatment. One participant in the Tibial Nerve First arm did not receive the Genital Nerve treatment. One participant in the Genital Nerve First arm did not receive the Tibial Nerve treatment. | Mean | Standard Deviation | beats per minute |
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| Baseline Mean Arterial Blood Pressure | Measure Description: Outcome measure was calculated as baseline of the total participants, regardless of which order they were administered the treatment. One participant in the Tibial Nerve First arm did not receive the Genital Nerve treatment. One participant in the Genital Nerve First arm did not receive the Tibial Nerve treatment. | Measure Description: Outcome measure was calculated as baseline of the total participants, regardless of which order they were administered the treatment. One participant in the Tibial Nerve First arm did not receive the Genital Nerve treatment. One participant in the Genital Nerve First arm did not receive the Tibial Nerve treatment. | Mean | Standard Deviation | mm Hg |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | VPA will be measured by a vaginal plethysmography transducer that is placed in the vagina to measure changes in blood flow during the full study session. Overall treatment sequence: baseline (nature) video erotic video 1 (no treatment = "control") baseline nature video (treatment on in middle) erotic video 2 (treatment) The average VPA value during the baseline period will be determined. The maximum percent change in VPA during each relevant sequence as compared to the average baseline VPA will be determined for each participant. | Analysis population is all participants who received the designated treatment, regardless of which treatment they received first or if they continued to the second treatment. | Posted | Mean | Standard Deviation | percent change of VPA | Up to five months |
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| Secondary | Percent Change in Heart Rate 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) to measure the heart rate in beats per minute (bpm). The average heart rate in bpm during the baseline video will be determined. The average percent change in heart rate during each test sequence as compared to the average baseline heart rate will be determined. | Analysis population is all participants who received the designated treatment, regardless of which treatment they received first or if they continued to the second treatment. | Posted | Mean | Standard Deviation | percent change of heart rate | Up to five months |
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| Secondary | Percent Change in Mean Arterial Blood Pressure 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. The mean arterial blood pressure in millimeters of mercury (mm Hg) will be calculated for a period as the diastolic pressure plus 1/3 times the difference between the systolic pressure and the diastolic pressure, following standard practice. The average mean arterial blood pressure will be determined for the baseline period. The percent change in average mean arterial blood pressure with respect to the baseline period will be determined for each test sequence. | Analysis population is all participants who received the designated treatment, regardless of which treatment they received first or if they continued to the second treatment. | Posted | Mean | Standard Deviation | percent change of mean arterial blood pr | Up to five months |
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| Secondary | Change in Subjective Arousal From Baseline | Subjective arousal will be evaluated by participants using a five point Likert scale, where 1 being no arousal and 5 being greatest arousal. Survey will be presented to patients between every video transition (a total of 4 times). Data is presented as averages per video transition point. | Analysis population is all participants who received the designated treatment, regardless of which treatment they received first or if they continued to the second treatment. | Posted | Mean | Standard Deviation | score on a scale | Up to five months |
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Up to five 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) |
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| EG000 | Tibial Nerve Stimulation | Participants received tibial nerve stimulation and Film Clip Alternation. 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 Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG001 | Genital Nerve Stimulation | Participants received genital nerve stimulation and Film Clip Alternation. 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. Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. | 0 | 14 | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Bruns | University of Michigan at Ann Arbor | (734) 647-8727 | bruns@umich.edu |
| Jun 5, 2025 |
| Prot_SAP_000.pdf |
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| Multiracial |
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| Asian/Pacific Islander |
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| Black/African American |
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| Native American/American Indian/Alaskan Native |
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| Other |
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| Genital Nerve VPA Baseline |
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| Genital Nerve Stimulation Baseline |
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| Genital Nerve Stimulation Baseline |
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| end of first video to end of second erotic video |
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| OG001 | Genital Nerve Stimulation | Participants received genital nerve stimulation and Film Clip Alternation. 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. Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. |
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| OG001 | Genital Nerve Stimulation | Participants received genital nerve stimulation and Film Clip Alternation. 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. Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. |
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| OG001 | Genital Nerve Stimulation | Participants received genital nerve stimulation and Film Clip Alternation. 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. Neutral and Erotic Film Clip Alternation: During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. |
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