Your session is about to expire
← Back to Search
Neuromodulation
Nerve Stimulation for Female Sexual Dysfunction
N/A
Recruiting
Led By Tim Bruns, Ph.D.
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up test baseline (approximately minute 0) up to test completion (approximately minute 60)
Awards & highlights
Study Summary
This trial will test whether or not a nerve stimulator can increase blood flow to the vagina in women with different degrees of sexual dysfunction.
Who is the study for?
This trial is for adult cis-gender females over 18, with or without sexual dysfunction and spinal cord injury. Participants should be neurologically stable, sexually active at least once a month, and able to communicate with the research team. Pregnant women or those planning pregnancy during the study are excluded.Check my eligibility
What is being tested?
The trial examines if tibial e-stim and genital e-stim can affect vaginal blood flow in women with different health conditions: healthy ones, those with non-neurogenic sexual dysfunction, and those suffering from neurogenic dysfunction due to spinal cord injury.See study design
What are the potential side effects?
Potential side effects of nerve stimulation may include discomfort at the stimulation site, temporary muscle twitching or cramping during treatment sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ test baseline (approximately minute 0) up to test completion (approximately minute 60)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~test baseline (approximately minute 0) up to test completion (approximately minute 60)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum change in vaginal pulse amplitude (VPA) from the average baseline value
Secondary outcome measures
Maximum change in blood pressure from baseline
Maximum change in heart rate from baseline
Trial Design
2Treatment groups
Experimental Treatment
Group I: Tibial e-stim followed by genital e-stimExperimental Treatment2 Interventions
Tibial e-stim followed by genital e-stim
Group II: Genital e-stim followed by tibial e-stimExperimental Treatment2 Interventions
Genital e-stim followed by tibial e-stim
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,098 Total Patients Enrolled
International Society for the Study of Women's Sexual HealthUNKNOWN
The Craig H. Neilsen FoundationOTHER
55 Previous Clinical Trials
2,895 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a male who is not planning to have a baby during the study, and you don't have certain medical conditions like bladder problems, epilepsy, or active infections.You are a male with sexual dysfunction, or you are pregnant or planning to become pregnant during the study. You have bladder or pelvic issues, active infection or pressure sores in the pelvic area, have a pacemaker or defibrillator, or have tested positive for COVID-19 in the last 14 days or have COVID-19 symptoms.Criterion: You have a spinal cord injury that affects certain levels of your spine, or you have certain health conditions like epilepsy, pregnancy, active infection, or recent positive COVID-19 test that excludes you from participating in the study.You are a cis-gender female over 18 years old, with no spinal cord injury, and are able to communicate effectively with the research team.Women over 18 who have difficulty with sexual arousal and lubrication, are sexually active at least once a month, are neurologically stable, and can communicate effectively with the research team.Women over 18 years old with a spinal cord injury at a specific level who are experiencing sexual dysfunction and can effectively communicate with the research team.
Research Study Groups:
This trial has the following groups:- Group 1: Genital e-stim followed by tibial e-stim
- Group 2: Tibial e-stim followed by genital e-stim
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants accepted to this experiment?
"Affirmative. The clinical trial is actively seeking participants, as stated on the information found on clinicaltrials.gov. It was initially published on November 11th 2020 and last updated November 17th 2022; this study necessitates 40 people across a single medical centre."
Answered by AI
Are there currently any openings to join this trial?
"Affirmative. Per the information present on clinicaltrials.gov, this research study is actively enrolling participants at the moment. It was initially published on November 11th 2020 and last updated on November 17th 2022; 40 individuals are needed across a single location."
Answered by AI
Popular Categories
Share this study with friends
Copy Link
Messenger