Long Term Genital Nerve Stimulation to Improve Urinary Continence

Status: Completed
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Bladder spasms after spinal cord injury (SCI) can result in incontinence, urinary tract infections, kidney damage, trigger dangerous increases in blood pressure and decrease independence and quality of life. The investigators' long-term goal is to develop and provide a bladder pacemaker able to restore bladder continence for Veterans with SCI. Electrical stimulation of sensory nerves can stop bladder spasms during a doctor visit. However, this approach has not been tested during long term home use. This proposal will 1) determine how well sensory stimulation reduces incontinence and improves quality of life for Veterans with SCI during 1 year of home use, and 2) produce an effective take home system that can be used by more Veterans and other VAs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Suprasacral neurogenic bladder following spinal cord injury, stroke, or multiple sclerosis

• Neurologically stable

• Skeletally mature, over 18 years of age.

• Reflex bladder contractions confirmed by cystometrogram

• At least six (6) months post spinal cord injury, stroke, or multiple sclerosis diagnosis

• Able to understand and comply with study requirements

• Able to understand and give informed consent

Locations
United States
New York
Syracuse VA Medical Center, Syracuse, NY
Syracuse
Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland
Time Frame
Start Date: 2019-11-01
Completion Date: 2023-09-30
Participants
Target number of participants: 17
Treatments
Experimental: Genital Nerve Stimulation
Study participants in this arm will use take-home genital nerve stimulation for 24+ months in order to assess its effectiveness at decreasing urinary incontinence. In order to set effective genital nerve stimulation parameters, study participants will undergo clinical urodynamics every 6 months in which sensitivity to and tolerance of electrical stimulation are assessed.
Authors
Kenneth J. Gustafson
Sponsors
Leads: VA Office of Research and Development
Collaborators: Syracuse VA Medical Center

This content was sourced from clinicaltrials.gov