Trial Outcomes & Findings for Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2 (NCT NCT06999265)
NCT ID: NCT06999265
Last Updated: 2025-07-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Up to five months
Results posted on
2025-07-16
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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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|---|---|---|
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Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Tibial Nerve Stimulation, Then Genital Nerve Stimulation
n=10 Participants
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.
|
Genital Nerve Stimulation, Then Tibial Nerve Stimulation
n=5 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 12.7 • n=10 Participants
|
35.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 11.7 • n=15 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
6 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
3 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Native American/American Indian/Alaskan Native
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
|
Baseline Vaginal Pulse Amplitude (VPA)
Tibial Nerve VPA Baseline
|
20.6 mV
STANDARD_DEVIATION 10.1 • n=10 Participants • 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.
|
12.8 mV
STANDARD_DEVIATION 14.0 • n=4 Participants • 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.
|
18.3 mV
STANDARD_DEVIATION 11.4 • n=14 Participants • 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.
|
|
Baseline Vaginal Pulse Amplitude (VPA)
Genital Nerve VPA Baseline
|
21.5 mV
STANDARD_DEVIATION 16.5 • n=9 Participants • 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.
|
17.6 mV
STANDARD_DEVIATION 15.0 • n=5 Participants • 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.
|
20.1 mV
STANDARD_DEVIATION 15.5 • n=14 Participants • 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.
|
|
Baseline Heart Rate
Tibial Nerve Stimulation Baseline
|
69.3 beats per minute
STANDARD_DEVIATION 10.9 • n=10 Participants • 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.
|
63.7 beats per minute
STANDARD_DEVIATION 4.9 • n=4 Participants • 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.
|
67.7 beats per minute
STANDARD_DEVIATION 9.8 • n=14 Participants • 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.
|
|
Baseline Heart Rate
Genital Nerve Stimulation Baseline
|
67.3 beats per minute
STANDARD_DEVIATION 7.1 • n=9 Participants • 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.
|
68.8 beats per minute
STANDARD_DEVIATION 8.7 • n=5 Participants • 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.
|
67.8 beats per minute
STANDARD_DEVIATION 7.4 • n=14 Participants • 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.
|
|
Baseline Mean Arterial Blood Pressure
Tibial Nerve Stimulation Baseline
|
81.8 mm Hg
STANDARD_DEVIATION 4.0 • n=10 Participants • 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.
|
79.3 mm Hg
STANDARD_DEVIATION 4.1 • n=4 Participants • 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.
|
81.1 mm Hg
STANDARD_DEVIATION 4.0 • n=14 Participants • 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.
|
|
Baseline Mean Arterial Blood Pressure
Genital Nerve Stimulation Baseline
|
85.2 mm Hg
STANDARD_DEVIATION 8.8 • n=9 Participants • 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.
|
82.6 mm Hg
STANDARD_DEVIATION 6.4 • n=5 Participants • 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.
|
84.2 mm Hg
STANDARD_DEVIATION 7.8 • n=14 Participants • 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.
|
PRIMARY outcome
Timeframe: Up to five monthsPopulation: 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.
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.
Outcome measures
| Measure |
Tibial Nerve Stimulation
n=14 Participants
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.
|
Genital Nerve Stimulation
n=14 Participants
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.
|
|---|---|---|
|
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
|
94.3 percent change of VPA
Standard Deviation 76.2
|
|
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
|
113.5 percent change of VPA
Standard Deviation 92.3
|
|
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
|
15.0 percent change of VPA
Standard Deviation 37.9
|
SECONDARY outcome
Timeframe: Up to five monthsPopulation: 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.
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.
Outcome measures
| Measure |
Tibial Nerve Stimulation
n=14 Participants
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.
|
Genital Nerve Stimulation
n=14 Participants
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.
|
|---|---|---|
|
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
|
0.8 percent change of heart rate
Standard Deviation 6.9
|
|
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
|
2.8 percent change of heart rate
Standard Deviation 5.7
|
|
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
|
2.1 percent change of heart rate
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Up to five monthsPopulation: 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.
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.
Outcome measures
| Measure |
Tibial Nerve Stimulation
n=14 Participants
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.
|
Genital Nerve Stimulation
n=14 Participants
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.
|
|---|---|---|
|
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
|
1.9 percent change of mean arterial blood pr
Standard Deviation 4.6
|
|
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
|
3.4 percent change of mean arterial blood pr
Standard Deviation 7.0
|
|
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
|
1.5 percent change of mean arterial blood pr
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Up to five monthsPopulation: 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.
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.
Outcome measures
| Measure |
Tibial Nerve Stimulation
n=14 Participants
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.
|
Genital Nerve Stimulation
n=14 Participants
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.
|
|---|---|---|
|
Change in Subjective Arousal From Baseline
Baseline, before video 1 (Survey 1)
|
1.1 score on a scale
Standard Deviation 0.4
|
1.4 score on a scale
Standard Deviation 0.6
|
|
Change in Subjective Arousal From Baseline
After video 1 (Survey 2)
|
3.5 score on a scale
Standard Deviation 0.9
|
3.4 score on a scale
Standard Deviation 0.5
|
|
Change in Subjective Arousal From Baseline
Before video 2 (Survey 3)
|
1.4 score on a scale
Standard Deviation 0.6
|
1.6 score on a scale
Standard Deviation 0.8
|
|
Change in Subjective Arousal From Baseline
After video 2 (Survey 4)
|
3.9 score on a scale
Standard Deviation 1.1
|
4.0 score on a scale
Standard Deviation 0.5
|
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