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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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Sexual Dysfunction focused on measuring peripheral neuromodulation, stimulation, vaginal blood flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

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
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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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