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Completed

NCT Number: NCT03472599

Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse VA Medical Center, Syracuse, NY, Syracuse, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incontinence

    Time frame: Collected over 24 months

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

Secondary outcomes

  1. Bladder Capacity

    Time frame: Collected over 24 months

    The investigators will measure bladder capacity in mL during acute urodynamics trials

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Syracuse VA Medical Center

Registry information

Official study title

Long Term Genital Nerve Stimulation to Improve Urinary Continence

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2018
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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