We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Peripheral Neuromodulation on Vaginal Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384172
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : November 11, 2021
Sponsor:
Collaborators:
International Society for the Study of Women's Sexual Health
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Timothy Bruns, University of Michigan

Tracking Information
First Submitted Date  ICMJE May 7, 2020
First Posted Date  ICMJE May 12, 2020
Last Update Posted Date November 11, 2021
Actual Study Start Date  ICMJE November 11, 2020
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Official Title  ICMJE Effect of Peripheral Neuromodulation on Vaginal Blood Flow
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Female Sexual Dysfunction
  • Spinal Cord Injuries
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Tibial e-stim followed by genital e-stim
    Tibial e-stim followed by genital e-stim
    Interventions:
    • Device: Tibial e-stim
    • Device: Genital e-stim
  • Experimental: Genital e-stim followed by tibial e-stim
    Genital e-stim followed by tibial e-stim
    Interventions:
    • Device: Tibial e-stim
    • Device: Genital e-stim
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Cis-gender female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mackenzie Moore, MPH 734-647-8568 mooremac@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04384172
Other Study ID Numbers  ICMJE HUM00148746
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There are no plans to share IPD at this time.
Current Responsible Party Timothy Bruns, University of Michigan
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Michigan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • International Society for the Study of Women's Sexual Health
  • The Craig H. Neilsen Foundation
Investigators  ICMJE
Principal Investigator: Tim Bruns, Ph.D. University of Michigan
PRS Account University of Michigan
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP