Effect of Peripheral Neuromodulation on Vaginal Blood Flow

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04384172

Collaborator

International Society for the Study of Women's Sexual Health (Other), The Craig H. Neilsen Foundation (Other)

Enrollment

Location

Arms

32.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Female Sexual Dysfunction Spinal Cord Injuries	Device: Tibial e-stim Device: Genital e-stim	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Nov 11, 2020

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Maximum change in vaginal pulse amplitude (VPA) from the average baseline value [Test baseline (approximately minute 0) up to Test completion (approximately minute 60)]
VPA will be measured by a vaginal plethysmography transducer

Secondary Outcome Measures

Maximum change in heart rate from baseline [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan
International Society for the Study of Women's Sexual Health
The Craig H. Neilsen Foundation

Investigators

Principal Investigator: Tim Bruns, Ph.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

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.

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

Last Update Posted:

Nov 11, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Timothy Bruns, Associate Professor of Biomedical Engineering, Medical School, University of Michigan

peripheral neuromodulation

stimulation

vaginal blood flow

Additional relevant MeSH terms:

Spinal Cord Injuries

Study Results

No Results Posted as of Nov 11, 2021