Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

NCT06999265 | Completed Results FDA Device

• 1 other identifier: HUM00148746-b
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Dysfunction; Female Sexual Dysfunction Due to Physical Condition

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to five months

Secondary Outcomes (3)

• Percent Change in Heart Rate From Baseline

  Up to five months

• Percent Change in Mean Arterial Blood Pressure From Baseline

  Up to five months

• Change in Subjective Arousal From Baseline

  Up to five months

Study Arms (2)

Tibial nerve stimulation, then genital nerve stimulation

EXPERIMENTAL

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.

Device: Transcutaneous electrical nerve stimulation - Tibial Nerve; Device: Transcutaneous electrical nerve stimulation - Genital Nerve; Behavioral: Neutral and Erotic Film Clip Alternation

Genital nerve stimulation, then tibial nerve stimulation

EXPERIMENTAL

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.

Device: Transcutaneous electrical nerve stimulation - Tibial Nerve; Device: Transcutaneous electrical nerve stimulation - Genital Nerve; Behavioral: Neutral and Erotic Film Clip Alternation

Interventions

Transcutaneous electrical nerve stimulation - Tibial Nerve DEVICE

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

Genital nerve stimulation, then tibial nerve stimulation; Tibial nerve stimulation, then genital nerve stimulation

Transcutaneous electrical nerve stimulation - Genital Nerve DEVICE

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; Tibial nerve stimulation, then genital nerve stimulation

Neutral and Erotic Film Clip Alternation BEHAVIORAL

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.

Genital nerve stimulation, then tibial nerve stimulation; Tibial nerve stimulation, then genital nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only cisgendered females were eligible for this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• International Society for the Study of Women's Sexual Health: collaborator
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Tim Bruns
• Organization: University of Michigan at Ann Arbor

bruns@umich.edu

(734) 647-8727

Study Officials

• Tim Bruns, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Priyanka Gupta, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biomedical Engineering, Medical School

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: September 14, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-07

Locations

US (1)