Female Sexual Dysfunction, Spinal Cord Injuries
Conditions
Keywords
peripheral neuromodulation, stimulation, vaginal blood flow
Brief summary
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.
Detailed description
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.
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.
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
Intervention model description
Participants were randomized to one arm and completed the other arm 1-5 months later.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Non-dysfunction participants, no spinal cord injury Inclusion Criteria: * Adult (over 18 years old) cis-gender female * Neurologically stable * Sexually active at least once per month * Able to consent and communicate effectively with research team
Exclusion criteria
* Male * Pregnancy or planning to become pregnant during study period * 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 4 * 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, defibrillator, spinal cord stimulator, or other nerve stimulator * Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19. Sexual dysfunction participants, non- spinal cord injury Inclusion Criteria: * Adult (over 18 years old) cis-gender female * Neurologically stable * Sexually active at least once per month * Sexual dysfunction, per short-form 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Heart Rate After Stimulation From Baseline | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | 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) |
| Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | 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. |
| Change in Subjective Arousal After Stimulation | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Tibial Nerve Stimulation Then Genital Nerve Stimulation | Genital Nerve Stimulation Then Tibial Nerve Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Baseline Arousal Score Genital nerve stimulation baseline | 1.4 score on a scale STANDARD_DEVIATION 0.8 | 1.4 score on a scale STANDARD_DEVIATION 0.8 | 1.4 score on a scale STANDARD_DEVIATION 0.7 |
| Baseline Arousal Score Tibial nerve stimulation baseline | 1.4 score on a scale STANDARD_DEVIATION 0.9 | 1 score on a scale STANDARD_DEVIATION 0 | 1.3 score on a scale STANDARD_DEVIATION 0.8 |
| Baseline Heart Rate Genital nerve stimulation baseline | 68.5 bpm STANDARD_DEVIATION 12.7 | 77.5 bpm STANDARD_DEVIATION 10.1 | 73.0 bpm STANDARD_DEVIATION 11.7 |
| Baseline Heart Rate Tibial nerve stimulation baseline | 70.6 bpm STANDARD_DEVIATION 11.8 | 108 bpm STANDARD_DEVIATION 0 | 76.8 bpm STANDARD_DEVIATION 18.5 |
| Baseline Mean Arterial Pressure Genital nerve stimulation baseline | 80.3 mmHg STANDARD_DEVIATION 7.1 | 71.9 mmHg STANDARD_DEVIATION 3.7 | 76.1 mmHg STANDARD_DEVIATION 6.9 |
| Baseline Mean Arterial Pressure Tibial nerve stimulation baseline | 82.4 mmHg STANDARD_DEVIATION 6.1 | 75 mmHg STANDARD_DEVIATION 0 | 81.2 mmHg STANDARD_DEVIATION 6.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Vaginal Pulse Amplitude (VPA) Genital nerve stimulation baseline | 13.4 mV STANDARD_DEVIATION 8.6 | 41.2 mV STANDARD_DEVIATION 42.2 | 29.3 mV STANDARD_DEVIATION 33.7 |
| Vaginal Pulse Amplitude (VPA) Tibial Nerve stimulation session | 14.3 mV STANDARD_DEVIATION 11.3 | 18.1 mV STANDARD_DEVIATION 0 | 15.0 mV STANDARD_DEVIATION 10 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
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.
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tibial Nerve Stimulation | Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value | 3.3 Percent change | Standard Deviation 14.2 |
| Genital Nerve Stimulation | Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value | 3.5 Percent change | Standard Deviation 26.7 |
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.
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Population: Data was analyzed for each treatment, regardless of the order in which the participant received it.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tibial Nerve Stimulation | Change in Subjective Arousal After Stimulation | 0.5 score on a scale | Standard Deviation 1.2 |
| Genital Nerve Stimulation | Change in Subjective Arousal After Stimulation | 1.1 score on a scale | Standard Deviation 1 |
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)
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Population: Data was analyzed for each treatment, regardless of the order in which the participant received it.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tibial Nerve Stimulation | Percent Change in Heart Rate After Stimulation From Baseline | -6.7 percent change | Standard Deviation 7.1 |
| Genital Nerve Stimulation | Percent Change in Heart Rate After Stimulation From Baseline | 6.0 percent change | Standard Deviation 13.2 |
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.
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Population: Data was analyzed for each treatment, regardless of the order in which the participant received it.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tibial Nerve Stimulation | Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline | 2.3 percent change | Standard Deviation 4.8 |
| Genital Nerve Stimulation | Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline | 5.6 percent change | Standard Deviation 13.4 |