Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder

Description

Incontinence associates with military service and post-traumatic stress disorder in both male and female Veterans. Neurogenic detrusor overactivity (NDO) is caused by spinal cord injury or disorder, or peripheral neurodegenerative conditions, and causes urine leakage at low volumes. NDO is disproportionately experienced by Veterans and treatment effectiveness varies greatly between individuals. This project will demonstrate the feasibility of a new type of nerve stimulation-triggered sacral neuromodulation-to treat NDO in Veterans. A wireless bladder sensor will be inserted into the bladder to transmit a feedback signal enabling stimulation from a percutaneous lead. The wireless sensor will also measure NDO symptoms during simulated activities of daily living without catheters. Catheter-free detection of bladder activity will improve the outcomes of neuromodulation evaluations for Veterans with NDO. Future work could use the triggered neuromodulation system to study other methods of nerve stimulation to treat bladder, bowel, or sexual dysfunction.

Conditions

Urinary Incontinence, Urinary Bladder, Neurogenic

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Study Overview

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Study Details

Study overview

Incontinence associates with military service and post-traumatic stress disorder in both male and female Veterans. Neurogenic detrusor overactivity (NDO) is caused by spinal cord injury or disorder, or peripheral neurodegenerative conditions, and causes urine leakage at low volumes. NDO is disproportionately experienced by Veterans and treatment effectiveness varies greatly between individuals. This project will demonstrate the feasibility of a new type of nerve stimulation-triggered sacral neuromodulation-to treat NDO in Veterans. A wireless bladder sensor will be inserted into the bladder to transmit a feedback signal enabling stimulation from a percutaneous lead. The wireless sensor will also measure NDO symptoms during simulated activities of daily living without catheters. Catheter-free detection of bladder activity will improve the outcomes of neuromodulation evaluations for Veterans with NDO. Future work could use the triggered neuromodulation system to study other methods of nerve stimulation to treat bladder, bowel, or sexual dysfunction.

Triggered Sacral Neuromodulation to Treat Neurogenic Detrusor Overactivity Based on Algorithmic Classification of Bladder Filling Status From Wireless Pressure Data.

Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder

Condition
Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Cleveland

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States, 44106-1702

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of neurogenic lower urinary tract dysfunction consistent with International Continence Society definition which includes all bladder/urinary sphincter dysfunction related to any neurological disease or injury
  • * Male or female
  • * If SCI, time from injury \> 6 months to allow for recovery from the acute phase
  • * Can tolerate lying prone \> 1 hour
  • * Functional bladder capacity \> 100 mL confirmed by urodynamics examination
  • * Low risk of upper urinary tract deterioration
  • * Over 18 years of age, able to speak and understand English, capacity for consent
  • * Active urinary tract infection
  • * Chronic indwelling or suprapubic catheter usage
  • * Severe or rapidly progressive neurologic disease
  • * Abnormal sacral anatomy
  • * Anticipated need for MRI of body parts below the head
  • * Pelvic organ prolapse beyond the hymen
  • * Pregnancy
  • * Treatment with Botox injection within last six months
  • * Current treatment with percutaneous tibial nerve stimulation or other forms of neuromodulation
  • * History of sacral neuromodulation treatment or presence of sacral neuromodulation leads or implant
  • * Interstitial cystitis/bladder pain syndrome
  • * Benign prostatic hyperplasia preventing catheterization to empty
  • * History of anatomically relevant pelvic or anti-incontinence surgery

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Steve J Majerus, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center, Cleveland, OH

Study Record Dates

2024-10-29