Spinal Cord Injuries Clinical Trial
Official title:
Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Verified date | June 2024 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The researchers want to see if nerve stimulation interventions cause a 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.
Status | Completed |
Enrollment | 27 |
Est. completion date | June 5, 2024 |
Est. primary completion date | June 5, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Non-dysfunction participants, no spinal cord injury Inclusion Criteria: - 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 Criteria: - 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 Exclusion Criteria: - Male - Pregnancy or planning to become pregnant during study period - Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms - Active infection or active pressure sores in the pelvic region - Implanted pacemaker or defibrillator - Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19. Sexual dysfunction participants with spinal cord injury Inclusion Criteria: - Adult (over 18 years old) cis-gender women - 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: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | International Society for the Study of Women's Sexual Health, The Craig H. Neilsen Foundation |
United States,
Zimmerman LL, Gupta P, O'Gara F, Langhals NB, Berger MB, Bruns TM. Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. Neuromodulation. 2018 Oct;21(7):707-713. doi: 10.1111/ner.12846. Epub 2018 Sep 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum change in vaginal pulse amplitude (VPA) from the average baseline value | VPA will be measured by a vaginal plethysmography transducer | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | |
Secondary | Maximum change in heart rate from baseline | 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) | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | |
Secondary | Maximum change in blood pressure from baseline | 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. | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) |
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