Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Primary Purpose
Female Sexual Dysfunction, Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tibial e-stim
Genital e-stim
Sponsored by
About this trial
This is an interventional treatment trial for Female Sexual Dysfunction focused on measuring peripheral neuromodulation, stimulation, vaginal blood flow
Eligibility Criteria
Non-dysfunction participants, no spinal chord injury
Inclusion Criteria:
- Neurologically stable
- Sexually active at least once per month
Exclusion Criteria:
- Pregnancy or planning to become pregnant during study period
- Sexual dysfunction, per short-form Female Sexual Function Index (FSFI) score below 19
- Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
- Previous pelvic surgery
- Recent use of TENS on the pelvis, back or legs
- Implanted pacemaker, defibrillator, spinal cord stimulator, or other nerve stimulator
- Currently taking any experimental drug
Sexual dysfunction participants, non- spinal chord injury
Inclusion Criteria:
- Neurologically stable
- Sexually active at least once per month
- Sexual dysfunction, per short-form FSFI score below 19
- Able to understand consent and communicate effectively with research team
Exclusion Criteria:
- Pregnancy or planning to become pregnant during study period
- Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
- Previous pelvic surgery
- Active sepsis or active pressure sores in the pelvic region
- Experience with electrical stimulation for bladder or sexual problems
- Recent use of TENS on the pelvis, back or legs
- Implanted pacemaker, defibrillator, spinal cord stimulator, or other nerve stimulator
- Currently taking any experimental drug
Sexual dysfunction participants with spinal cord injury
Inclusion Criteria:
- Clinically diagnosed spinal cord injury American Spinal Injury Association Impairment Scale (AIS) A, B, or C 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:
- Spinal cord injury at or above T6 level
- Spinal cord injury at or below S2 level
- Reported change in motor or sensory function in the last month
- Diagnosed lower motor neuron syndrome or dysfunction
- Lower leg spasticity
- Pregnancy or planning to become pregnant during study period
- Previous pelvic surgery
- Active sepsis or active pressure sores in the pelvic region
- Experience with electrical stimulation for bladder or sexual problems
- Recent use of TENS on pelvis, back, or legs
- Implanted pacemaker, defibrillator, spinal cord stimulator, or other nerve stimulator
- Currently taking any experimental drug
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tibial e-stim followed by genital e-stim
Genital e-stim followed by tibial e-stim
Arm Description
Tibial e-stim followed by genital e-stim
Genital e-stim followed by tibial e-stim
Outcomes
Primary Outcome Measures
Maximum change in vaginal pulse amplitude (VPA) from the average baseline value
VPA will be measured by a vaginal plethysmography transducer
Secondary Outcome Measures
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)
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.
Full Information
NCT ID
NCT04384172
First Posted
May 7, 2020
Last Updated
July 17, 2023
Sponsor
University of Michigan
Collaborators
International Society for the Study of Women's Sexual Health, The Craig H. Neilsen Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04384172
Brief Title
Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Official Title
Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
International Society for the Study of Women's Sexual Health, The Craig H. Neilsen Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Sexual Dysfunction, Spinal Cord Injuries
Keywords
peripheral neuromodulation, stimulation, vaginal blood flow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tibial e-stim followed by genital e-stim
Arm Type
Experimental
Arm Description
Tibial e-stim followed by genital e-stim
Arm Title
Genital e-stim followed by tibial e-stim
Arm Type
Experimental
Arm Description
Genital e-stim followed by tibial e-stim
Intervention Type
Device
Intervention Name(s)
Tibial e-stim
Intervention Description
For tibial nerve stimulation, the two electrodes will be placed just above the medial malleolus and the ipsilateral calcaneus on one leg near the ankle.
Intervention Type
Device
Intervention Name(s)
Genital e-stim
Intervention Description
For dorsal genital nerve stimulation, two electrodes will be placed on either side of the clitoris.
Primary Outcome Measure Information:
Title
Maximum change in vaginal pulse amplitude (VPA) from the average baseline value
Description
VPA will be measured by a vaginal plethysmography transducer
Time Frame
Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Secondary Outcome Measure Information:
Title
Maximum change in heart rate from baseline
Description
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)
Time Frame
Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Title
Maximum change in blood pressure from baseline
Description
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.
Time Frame
Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Cis-gender female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mackenzie Moore, MPH
Phone
734-647-8568
Email
mooremac@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Bruns, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mackenzie Moore, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share IPD at this time.
Citations:
PubMed Identifier
30247794
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.
Results Reference
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Effect of Peripheral Neuromodulation on Vaginal Blood Flow
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