Clinical trial NCT06999265: Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2
Official title: Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Sexual Dysfunction
Female Sexual Dysfunction Due to Physical Condition
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: 2025-05-31
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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-term 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, to reveal mechanisms underlying neural control over vaginal blood flow.

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 FSD and spinal cord injuries (SCI). To potentially amplify any stimulation effects, this study will incorporate the use of sexually explicit films, a method that is standard in sexual function studies.

Eligibility criteria: Inclusion Criteria:

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 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 (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:

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 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 VPA from the average baseline value
timeFrame: Up to five months
Secondary outcomes:
measure: Change in heart rate from baseline
timeFrame: Up to five months
measure: Change in mean arterial blood pressure from baseline
timeFrame: Up to five months
measure: Change in subjective arousal from baseline
timeFrame: Up to five months
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
affiliation: University of Michigan
name: Priyanka Gupta, M.D.
role: PRINCIPAL_INVESTIGATOR
References: