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Effect of Peripheral Neuromodulation on Vaginal Blood Flow

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ClinicalTrials.gov Identifier: NCT04384172
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
International Society for the Study of Women's Sexual Health
Information provided by (Responsible Party):
Timothy Bruns, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Female Sexual Dysfunction Spinal Cord Injuries Device: Tibial e-stim Device: Genital e-stim Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tibial e-stim followed by genital e-stim
Tibial e-stim followed by genital e-stim
Device: Tibial e-stim
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.

Device: Genital e-stim
For dorsal genital nerve stimulation, two electrodes will be placed on either side of the clitoris.

Experimental: Genital e-stim followed by tibial e-stim
Genital e-stim followed by tibial e-stim
Device: Tibial e-stim
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.

Device: Genital e-stim
For dorsal genital nerve stimulation, two electrodes will be placed on either side of the clitoris.




Primary Outcome Measures :
  1. Maximum change in vaginal pulse amplitude (VPA) from the average baseline value [ Time Frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60) ]
    VPA will be measured by a vaginal plethysmography transducer


Secondary Outcome Measures :
  1. Maximum change in heart rate from baseline [ Time Frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60) ]
    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)

  2. Maximum change in blood pressure from baseline [ Time Frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cis-gender female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384172


Contacts
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Contact: Vanessa Pruitt, MSW 734-647-8568 vanesspr@med.umich.edu

Sponsors and Collaborators
University of Michigan
International Society for the Study of Women's Sexual Health
Investigators
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Principal Investigator: Tim Bruns, Ph.D. University of Michigan
Publications:
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Responsible Party: Timothy Bruns, Associate Professor of Biomedical Engineering, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT04384172    
Other Study ID Numbers: HUM00148746
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share IPD at this time.

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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
Keywords provided by Timothy Bruns, University of Michigan:
peripheral neuromodulation
stimulation
vaginal blood flow
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries