Trial Outcomes & Findings for Effect of Peripheral Neuromodulation on Vaginal Blood Flow (NCT NCT04384172)
NCT ID: NCT04384172
Last Updated: 2025-11-12
Results Overview
VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
Washout period
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Tibial Nerve Stimulation Then Genital Nerve Stimulation
n=5 Participants
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.
|
Genital Nerve Stimulation Then Tibial Nerve Stimulation
n=4 Participants
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.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
|
Vaginal Pulse Amplitude (VPA)
Tibial Nerve stimulation session
|
14.3 mV
STANDARD_DEVIATION 11.3 • n=4 Participants • 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.
|
18.1 mV
STANDARD_DEVIATION 0 • n=1 Participants • 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.
|
15.0 mV
STANDARD_DEVIATION 10.0 • n=5 Participants • 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.
|
|
Vaginal Pulse Amplitude (VPA)
Genital nerve stimulation baseline
|
13.4 mV
STANDARD_DEVIATION 8.6 • n=3 Participants • 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.
|
41.2 mV
STANDARD_DEVIATION 42.2 • n=4 Participants • 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.
|
29.3 mV
STANDARD_DEVIATION 33.7 • n=7 Participants • 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.
|
|
Baseline Heart Rate
Tibial nerve stimulation baseline
|
70.6 bpm
STANDARD_DEVIATION 11.8 • n=5 Participants • Participants who did not complete study did not have a baseline measure for the stimulation session that they missed.
|
108 bpm
STANDARD_DEVIATION 0 • n=1 Participants • Participants who did not complete study did not have a baseline measure for the stimulation session that they missed.
|
76.8 bpm
STANDARD_DEVIATION 18.5 • n=6 Participants • Participants who did not complete study did not have a baseline measure for the stimulation session that they missed.
|
|
Baseline Heart Rate
Genital nerve stimulation baseline
|
68.5 bpm
STANDARD_DEVIATION 12.7 • n=4 Participants • Participants who did not complete study did not have a baseline measure for the stimulation session that they missed.
|
77.5 bpm
STANDARD_DEVIATION 10.1 • n=4 Participants • Participants who did not complete study did not have a baseline measure for the stimulation session that they missed.
|
73.0 bpm
STANDARD_DEVIATION 11.7 • n=8 Participants • Participants who did not complete study did not have a baseline measure for the stimulation session that they missed.
|
|
Baseline Mean Arterial Pressure
Tibial nerve stimulation baseline
|
82.4 mmHg
STANDARD_DEVIATION 6.1 • n=5 Participants • Participants who did not complete both sessions did not have a baseline value for the stimulation session that they missed.
|
75 mmHg
STANDARD_DEVIATION 0 • n=1 Participants • Participants who did not complete both sessions did not have a baseline value for the stimulation session that they missed.
|
81.2 mmHg
STANDARD_DEVIATION 6.3 • n=6 Participants • Participants who did not complete both sessions did not have a baseline value for the stimulation session that they missed.
|
|
Baseline Mean Arterial Pressure
Genital nerve stimulation baseline
|
80.3 mmHg
STANDARD_DEVIATION 7.1 • n=4 Participants • Participants who did not complete both sessions did not have a baseline value for the stimulation session that they missed.
|
71.9 mmHg
STANDARD_DEVIATION 3.7 • n=4 Participants • Participants who did not complete both sessions did not have a baseline value for the stimulation session that they missed.
|
76.1 mmHg
STANDARD_DEVIATION 6.9 • n=8 Participants • Participants who did not complete both sessions did not have a baseline value for the stimulation session that they missed.
|
|
Baseline Arousal Score
Tibial nerve stimulation baseline
|
1.4 score on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants • Participants who did not complete both sessions did not have a baseline score for the stimulation session that they missed.
|
1 score on a scale
STANDARD_DEVIATION 0 • n=1 Participants • Participants who did not complete both sessions did not have a baseline score for the stimulation session that they missed.
|
1.3 score on a scale
STANDARD_DEVIATION 0.8 • n=6 Participants • Participants who did not complete both sessions did not have a baseline score for the stimulation session that they missed.
|
|
Baseline Arousal Score
Genital nerve stimulation baseline
|
1.4 score on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants • Participants who did not complete both sessions did not have a baseline score for the stimulation session that they missed.
|
1.4 score on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants • Participants who did not complete both sessions did not have a baseline score for the stimulation session that they missed.
|
1.4 score on a scale
STANDARD_DEVIATION 0.7 • n=8 Participants • Participants who did not complete both sessions did not have a baseline score for the stimulation session that they missed.
|
PRIMARY outcome
Timeframe: 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.
VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow.
Outcome measures
| Measure |
Tibial Nerve Stimulation
n=5 Participants
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
|
Genital Nerve Stimulation
n=7 Participants
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.
|
|---|---|---|
|
Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value
|
3.3 Percent change
Standard Deviation 14.2
|
3.5 Percent change
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: 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.
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)
Outcome measures
| Measure |
Tibial Nerve Stimulation
n=6 Participants
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
|
Genital Nerve Stimulation
n=8 Participants
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.
|
|---|---|---|
|
Percent Change in Heart Rate After Stimulation From Baseline
|
-6.7 percent change
Standard Deviation 7.1
|
6.0 percent change
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tibial Nerve Stimulation
n=6 Participants
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
|
Genital Nerve Stimulation
n=8 Participants
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.
|
|---|---|---|
|
Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline
|
2.3 percent change
Standard Deviation 4.8
|
5.6 percent change
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tibial Nerve Stimulation
n=6 Participants
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
|
Genital Nerve Stimulation
n=8 Participants
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.
|
|---|---|---|
|
Change in Subjective Arousal After Stimulation
|
0.5 score on a scale
Standard Deviation 1.2
|
1.1 score on a scale
Standard Deviation 1.0
|
Adverse Events
Tibial Nerve Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genital Nerve Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place