Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

October 24, 2023 updated by: VA Office of Research and Development

Long Term Genital Nerve Stimulation to Improve Urinary Continence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The clinical problem of neurogenic detrusor overactivity (bladder hyper-reflexia) is among the most serious problems encountered by Veterans with neurologic injuries such as spinal cord injury (SCI). The majority of persons with SCI suffer from neurogenic bladder (73%) and only 17% of persons with traumatic SCI manage their bladders with voluntary micturition. The investigators' long-term goal is to develop and clinically implement a "bladder pacemaker" able to restore bladder continence for Veterans with spinal cord injury (SCI). This proposal will 1) determine the long-term effectiveness of genital nerve stimulation (GNS) to chronically ( 1 year) reduce urinary incontinence and improve quality of life for Veterans with SCI, and 2) develop and produce an effective take home GNS system that can be used by more Veterans, given to Veterans at the end of the study and used in future multi-VA studies.

The rationale for studying chronic GNS is based on the demonstration in humans with SCI that abnormal hyper-reflexive bladder contractions can be acutely inhibited and bladder capacity acutely increased using GNS. The peripheral and easily accessible location of the dorsal genital nerve (DGN) allows surface stimulation and therefore provides the potential for a less complicated surgical intervention than is currently available, increasing the number of individuals who could benefit from bladder control neural prostheses. While GNS has been demonstrated to be effective acutely by multiple groups, relatively few groups have attempted to test this approach for more than a day.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • Syracuse VA Medical Center, Syracuse, NY
    • Ohio
      • Cleveland, Ohio, United States, 44106-1702
        • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active sepsis
  • Open pressure sores on penis
  • Significant trauma, erosion or stricture of the urethra
  • Pregnancy
  • Individuals who do not speak English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Genital Nerve Stimulation
Genital nerve stimulation activates sensory afferents that travel through the pudendal nerves and enters the spinal cord through the sacral dorsal root ganglia. Inhibitory spinal reflex pathways are activated, causing increased sympathetic outflow through the inferior mesenteric ganglion and hypogastric nerve and also decreased parasympathetic efferent drive through the pelvic nerve, resulting in inhibited bladder contractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence
Time Frame: Collected over 24 months
The investigators will collect a record of leakage episodes (metric for incontinence) from the specified period.
Collected over 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder Capacity
Time Frame: Collected over 24 months
The investigators will measure bladder capacity in mL during acute urodynamics trials
Collected over 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Syracuse VA Medical Center

Investigators

  • Principal Investigator: Kenneth J. Gustafson, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2512-R
  • RX002512 (Other Grant/Funding Number: VA Office of Research and Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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