Female Sexual Dysfunction, Female Sexual Dysfunction Due to Physical Condition
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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
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.
BEHAVIORALNeutral 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. 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.
Sponsors
International Society for the Study of Women's Sexual Health
The Craig H. Neilsen Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All Participants * All participants will need internet access to complete the initial surveys and the diaries. Non-dysfunction participants * Adult (over 18 years old) cis-gender female * Neurologically stable * Sexually active at least once per month * Able to understand consent and communicate effectively with research team Non-SCI dysfunction participants * Adult (over 18 years old) cis-gender female * Neurologically stable * Sexually active at least once per month * Sexual dysfunction, per short-form Female Sexual Function Index (FSFI) score below 19 * Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 3 * Able to understand consent and communicate effectively with research team Spinal cord injured participants * Adult (over 18 years old) cis-gender female * Clinically diagnosed spinal cord injury (Impairment score A-B) at vertebral level within C6-T10 at least six months prior or clinically diagnosed spinal cord injury (Impairment score C) at vertebral level within C4-T10 at least six months prior * Nominally sexually active, but at minimum interest in sexual pleasure even if fully self-induced * Sexual dysfunction, per short-form FSFI score below 19 * Able to understand consent and communicate effectively with research team
Exclusion criteria
Non-dysfunction participants: * Male * Pregnancy or planning to become pregnant during study period * Sexual dysfunction, per short-form FSFI score below 19 * Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 4, or per investigator's discretion * Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms * Suspected or diagnosed epilepsy * Active infection or active pressure sores in the perineal region * Implanted pacemaker or defibrillator * Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19 Non-SCI dysfunction participants: * Male * Pregnancy or planning to become pregnant during study period * Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms * Suspected or diagnosed epilepsy * Active infection or active pressure sores in the perineal region * Implanted pacemaker or defibrillator * Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19 Spinal cord injured participants: * Male * Spinal cord injury at or above C5 level (C1-C5) if Impairment score A or B, or spinal cord injury at or above C3 level (C1-C3) if Impairment score C * Spinal cord injury below T10 vertebral level or reflexes not preserved * Acute worsening in motor or sensory function in the last month * Suspected or diagnosed epilepsy * Pregnancy or planning to become pregnant during study period * Active infection or active pressure sores in the perineal region * Implanted pacemaker or defibrillator * Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | Up to five months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Heart Rate From Baseline | Up to five months | 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. |
| Percent Change in Mean Arterial Blood Pressure From Baseline | Up to five months | 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. |
| Change in Subjective Arousal From Baseline | Up to five months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 5 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Genital Nerve Stimulation, Then Tibial Nerve Stimulation | Tibial Nerve Stimulation, Then Genital Nerve Stimulation |
|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 11.7 | 35.6 years STANDARD_DEVIATION 10.7 | 38.2 years STANDARD_DEVIATION 12.7 |
| Baseline Heart Rate Genital Nerve Stimulation Baseline | 67.8 beats per minute STANDARD_DEVIATION 7.4 | 68.8 beats per minute STANDARD_DEVIATION 8.7 | 67.3 beats per minute STANDARD_DEVIATION 7.1 |
| Baseline Heart Rate Tibial Nerve Stimulation Baseline | 67.7 beats per minute STANDARD_DEVIATION 9.8 | 63.7 beats per minute STANDARD_DEVIATION 4.9 | 69.3 beats per minute STANDARD_DEVIATION 10.9 |
| Baseline Mean Arterial Blood Pressure Genital Nerve Stimulation Baseline | 84.2 mm Hg STANDARD_DEVIATION 7.8 | 82.6 mm Hg STANDARD_DEVIATION 6.4 | 85.2 mm Hg STANDARD_DEVIATION 8.8 |
| Baseline Mean Arterial Blood Pressure Tibial Nerve Stimulation Baseline | 81.1 mm Hg STANDARD_DEVIATION 4 | 79.3 mm Hg STANDARD_DEVIATION 4.1 | 81.8 mm Hg STANDARD_DEVIATION 4 |
| Baseline Vaginal Pulse Amplitude (VPA) Genital Nerve VPA Baseline | 20.1 mV STANDARD_DEVIATION 15.5 | 17.6 mV STANDARD_DEVIATION 15 | 21.5 mV STANDARD_DEVIATION 16.5 |
| Baseline Vaginal Pulse Amplitude (VPA) Tibial Nerve VPA Baseline | 18.3 mV STANDARD_DEVIATION 11.4 | 12.8 mV STANDARD_DEVIATION 14 | 20.6 mV STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black/African American | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native American/American Indian/Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Caucasian | 9 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 15 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 15 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: Up to five months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tibial Nerve Stimulation | Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | baseline to end of first erotic video | 119.8 percent change of VPA | Standard Deviation 107.4 |
| Tibial Nerve Stimulation | Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | baseline to end of second erotic video | 135.4 percent change of VPA | Standard Deviation 153.9 |
| Tibial Nerve Stimulation | Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | end of first video to end of second erotic video | 9.9 percent change of VPA | Standard Deviation 45.2 |
| Genital Nerve Stimulation | Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | baseline to end of first erotic video | 94.3 percent change of VPA | Standard Deviation 76.2 |
| Genital Nerve Stimulation | Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | baseline to end of second erotic video | 113.5 percent change of VPA | Standard Deviation 92.3 |
| Genital Nerve Stimulation | Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value | end of first video to end of second erotic video | 15.0 percent change of VPA | Standard Deviation 37.9 |
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.
Time frame: Up to five months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tibial Nerve Stimulation | Change in Subjective Arousal From Baseline | Before video 2 (Survey 3) | 1.4 score on a scale | Standard Deviation 0.6 |
| Tibial Nerve Stimulation | Change in Subjective Arousal From Baseline | After video 1 (Survey 2) | 3.5 score on a scale | Standard Deviation 0.9 |
| Tibial Nerve Stimulation | Change in Subjective Arousal From Baseline | After video 2 (Survey 4) | 3.9 score on a scale | Standard Deviation 1.1 |
| Tibial Nerve Stimulation | Change in Subjective Arousal From Baseline | Baseline, before video 1 (Survey 1) | 1.1 score on a scale | Standard Deviation 0.4 |
| Genital Nerve Stimulation | Change in Subjective Arousal From Baseline | After video 2 (Survey 4) | 4.0 score on a scale | Standard Deviation 0.5 |
| Genital Nerve Stimulation | Change in Subjective Arousal From Baseline | After video 1 (Survey 2) | 3.4 score on a scale | Standard Deviation 0.5 |
| Genital Nerve Stimulation | Change in Subjective Arousal From Baseline | Before video 2 (Survey 3) | 1.6 score on a scale | Standard Deviation 0.8 |
| Genital Nerve Stimulation | Change in Subjective Arousal From Baseline | Baseline, before video 1 (Survey 1) | 1.4 score on a scale | Standard Deviation 0.6 |
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.
Time frame: Up to five months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tibial Nerve Stimulation | Percent Change in Heart Rate From Baseline | baseline to end of first erotic video | 2.4 percent change of heart rate | Standard Deviation 6.1 |
| Tibial Nerve Stimulation | Percent Change in Heart Rate From Baseline | baseline to end of second erotic video | -0.5 percent change of heart rate | Standard Deviation 6.6 |
| Tibial Nerve Stimulation | Percent Change in Heart Rate From Baseline | end of first video to end of second erotic video | -2.8 percent change of heart rate | Standard Deviation 5.5 |
| Genital Nerve Stimulation | Percent Change in Heart Rate From Baseline | baseline to end of first erotic video | 0.8 percent change of heart rate | Standard Deviation 6.9 |
| Genital Nerve Stimulation | Percent Change in Heart Rate From Baseline | baseline to end of second erotic video | 2.8 percent change of heart rate | Standard Deviation 5.7 |
| Genital Nerve Stimulation | Percent Change in Heart Rate From Baseline | end of first video to end of second erotic video | 2.1 percent change of heart rate | Standard Deviation 5 |
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.
Time frame: Up to five months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tibial Nerve Stimulation | Percent Change in Mean Arterial Blood Pressure From Baseline | baseline to end of first erotic video | 1.8 percent change of mean arterial blood pr | Standard Deviation 5.5 |
| Tibial Nerve Stimulation | Percent Change in Mean Arterial Blood Pressure From Baseline | baseline to end of second erotic video | 2.1 percent change of mean arterial blood pr | Standard Deviation 5.6 |
| Tibial Nerve Stimulation | Percent Change in Mean Arterial Blood Pressure From Baseline | end of first video to end of second erotic video | 0.3 percent change of mean arterial blood pr | Standard Deviation 3.3 |
| Genital Nerve Stimulation | Percent Change in Mean Arterial Blood Pressure From Baseline | baseline to end of first erotic video | 1.9 percent change of mean arterial blood pr | Standard Deviation 4.6 |
| Genital Nerve Stimulation | Percent Change in Mean Arterial Blood Pressure From Baseline | baseline to end of second erotic video | 3.4 percent change of mean arterial blood pr | Standard Deviation 7 |
| Genital Nerve Stimulation | Percent Change in Mean Arterial Blood Pressure From Baseline | end of first video to end of second erotic video | 1.5 percent change of mean arterial blood pr | Standard Deviation 4.3 |