Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

Not Applicable

Completed

• Conditions: Female Sexual Dysfunction; Female Sexual Dysfunction Due to Physical Condition

• Registration Number: NCT06999265
• Lead Sponsor: University of Michigan

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-09-14
• Primary Completion: 2024-06-05
• Study Completion: 2024-06-05
• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

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 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

• Adult (over 18 years old) cis-gender female
• Clinically diagnosed spinal cord injury (AIS A-B) at vertebral level within C6-T10 at least six months prior or clinically diagnosed spinal cord injury (AIS C) at vertebral level within C4-T10 at least six months prior
• Nominally sexually active, but at minimum interest in sexual pleasure even if fully self-induced
• Sexual dysfunction, per short-form FSFI score below 19
• Able to understand consent and communicate effectively with research team

Exclusion Criteria

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
• 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

Spinal cord injured participants:

• Male
• Spinal cord injury at or above C5 level (C1-C5) if AIS A or B, or spinal cord injury at or above C3 level (C1-C3) if AIS C
• Spinal cord injury below T10 vertebral level or reflexes not preserved
• Acute worsening in motor or sensory function in the last month
• Suspected or diagnosed epilepsy
• Pregnancy or planning to become pregnant during study period
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Maximum change in VPA from the average baseline value	Up to five months	VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow.

Secondary Outcome Measures

Name	Time	Method
Change in heart rate from baseline	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)
Change in mean arterial blood pressure from baseline	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.
Change in subjective arousal from baseline	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 5 times). Data is presented as averages per video transition point.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States