Status:
COMPLETED
Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2
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
Female Sexual Dysfunction Due to Physical Condition
Eligibility:
FEMALE
18+ years
Phase:
NA
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-ter...
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 F...
Eligibility Criteria
Inclusion
- 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
- Adult (over 18 years old) cis-gender female
- Clinically diagnosed spinal cord injury (Impairment score A-B) at vertebral level within C6-T10 at least six months prior or clinically diagnosed spinal cord injury (Impairment score 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
- 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 Impairment score A or B, or spinal cord injury at or above C3 level (C1-C3) if Impairment score 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
Key Trial Info
Start Date :
September 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06999265
Start Date
September 14 2022
End Date
June 5 2024
Last Update
July 16 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109