University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT06999265
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Michigan
Other
Effect of Peripheral Neuromodulation on Vaginal Blood Flow
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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