Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Nov 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for veterans who experience a specific type of bladder dysfunction known as neurogenic detrusor overactivity (NDO), which can lead to unexpected urine leakage. This condition is often linked to spinal cord injuries or neurological issues and is more common in veterans, particularly those with a history of military service or post-traumatic stress disorder. The trial aims to test a device that uses a wireless sensor placed in the bladder to detect bladder activity and deliver nerve stimulation to help control these symptoms. This approach allows for monitoring of bladder issues without using catheters, which could improve care for veterans dealing with NDO.

To participate in this trial, individuals must be over 18 years old, able to speak and understand English, and have a diagnosis of bladder dysfunction related to a neurological condition. They should also have a certain bladder capacity and be able to lie comfortably on their stomach for at least an hour. However, those with active urinary tract infections, certain neurological diseases, or previous bladder surgeries may not be eligible. Participants will have the opportunity to try this new treatment and contribute to future research that could help others with similar bladder issues.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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