Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

NCT03472599 | Completed

• 2 other identifiers: B2512-RRX002512
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neurogenic Bladder Dysfunction

Keywords

Neurogenic bladder dysfunction; Genital Nerve Stimulation; Electrical Stimulation; Urinary Incontinence; Spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Incontinence

  The investigators will collect a record of leakage episodes (metric for incontinence) from the specified period.

  Collected over 24 months

Secondary Outcomes (1)

• Bladder Capacity

  Collected over 24 months

Study Arms (1)

Genital Nerve Stimulation

EXPERIMENTAL

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

Interventions

Genital Nerve Stimulation OTHER

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.

Genital Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Syracuse VA Medical Center: collaborator

Study Sites (2)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

Related Publications (2)

• Bourbeau DJ, Creasey GH, Sidik S, Brose SW, Gustafson KJ. Genital nerve stimulation increases bladder capacity after SCI: A meta-analysis. J Spinal Cord Med. 2018 Jul;41(4):426-434. doi: 10.1080/10790268.2017.1281372. Epub 2017 Feb 15.

  PMID: 28198657 BACKGROUND

• Bourbeau DJ, Gustafson KJ, Brose SW. At-home genital nerve stimulation for individuals with SCI and neurogenic detrusor overactivity: A pilot feasibility study. J Spinal Cord Med. 2019 May;42(3):360-370. doi: 10.1080/10790268.2017.1422881. Epub 2018 Jan 15.

  PMID: 29334338 RESULT

MeSH Terms

Conditions

Urinary Incontinence; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kenneth J. Gustafson, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: All subjects will take home skin surface electrodes and a simple one-channel electrical stimulators appropriate for extended use set to the stimulus parameters found effective during an initial urodynamics test. Genital nerve stimulation will be applied either continuously or on-demand when individuals turn stimulation on when they feel the onset of bladder leaking.

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 21, 2018
• Study Start: November 1, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)