Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

Neurogenic Bladder Dysfunction Clinical Trial

Official title:

Long Term Genital Nerve Stimulation to Improve Urinary Continence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472599
• Other study ID #: B2512-R
• Secondary ID: RX002512
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurogenic Bladder Dysfunction
• Urinary Bladder, Neurogenic

Intervention

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.

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Syracuse VA Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence	The investigators will collect a record of leakage episodes (metric for incontinence) from the specified period.	Collected over 24 months
Secondary	Bladder Capacity	The investigators will measure bladder capacity in mL during acute urodynamics trials	Collected over 24 months