RECRUITING

Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-10-03
Study Completion:2024-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05141487

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Male or female
  3. * If SCI, time from injury \> 6 months to allow for recovery from the acute phase
  4. * Can tolerate lying prone \> 1 hour
  5. * Functional bladder capacity \> 100 mL confirmed by urodynamics examination
  6. * Low risk of upper urinary tract deterioration
  7. * Over 18 years of age, able to speak and understand English, capacity for consent
  1. * Active urinary tract infection
  2. * Chronic indwelling or suprapubic catheter usage
  3. * Severe or rapidly progressive neurologic disease
  4. * Abnormal sacral anatomy
  5. * Anticipated need for MRI of body parts below the head
  6. * Pelvic organ prolapse beyond the hymen
  7. * Pregnancy
  8. * Treatment with Botox injection within last six months
  9. * Current treatment with percutaneous tibial nerve stimulation or other forms of neuromodulation
  10. * History of sacral neuromodulation treatment or presence of sacral neuromodulation leads or implant
  11. * Interstitial cystitis/bladder pain syndrome
  12. * Benign prostatic hyperplasia preventing catheterization to empty
  13. * History of anatomically relevant pelvic or anti-incontinence surgery

Contacts and Locations

Study Contact

Steve J Majerus, PhD
CONTACT
(216) 791-3800
Steve.Majerus@va.gov

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

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 Registration Dates

Study Start Date2022-10-03
Study Completion Date2024-10-29

Study Record Updates

Study Start Date2022-10-03
Study Completion Date2024-10-29

Terms related to this study

Keywords Provided by Researchers

  • Urinary Bladder, Neurogenic
  • Electric Stimulation
  • Transcutaneous Electric Nerve Stimulation

Additional Relevant MeSH Terms

  • Urinary Incontinence
  • Urinary Bladder, Neurogenic