Clinical trial NCT04384172: Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Official title: Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Sexual Dysfunction
Spinal Cord Injuries
Keywords: peripheral neuromodulation
stimulation
vaginal blood flow
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: International Society for the Study of Women's Sexual Health
name: The Craig H. Neilsen Foundation
First posted: 2020-05-12
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum change in vaginal pulse amplitude (VPA) from the average baseline value
timeFrame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Secondary outcomes:
measure: Maximum change in heart rate from baseline
timeFrame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
measure: Maximum change in blood pressure from baseline
timeFrame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tim Bruns, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.