Status:
COMPLETED
Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
International Society for the Study of Women's Sexual Health
The Craig H. Neilsen Foundation
Conditions:
Female Sexual Dysfunction
Spinal Cord Injuries
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The researchers want to see if nerve stimulation interventions cause a change in vaginal blood flow. This intervention was performed in women who have neurogenic (spinal cord injury) or non-neurogenic...
Detailed Description
Two nerve stimulation locations (genital nerve and tibial nerve) were targeted with skin-surface electrical stimulation in separate experimental sessions. This study was designed as a crossover study...
Eligibility Criteria
Inclusion
- Non-dysfunction participants, no spinal cord injury
- Adult (over 18 years old) cis-gender female
- Neurologically stable
- Sexually active at least once per month
- Able to consent and communicate effectively with research team
Exclusion
- Male
- Pregnancy or planning to become pregnant during study period
- 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 4
- 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, defibrillator, spinal cord stimulator, or other nerve stimulator
- Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19.
- Sexual dysfunction participants, non- spinal cord injury
- Inclusion Criteria:
- 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
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04384172
Start Date
November 11 2020
End Date
March 15 2022
Last Update
November 12 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109