Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder

NCT05141487 | Recruiting DMC

• 1 other identifier: A3687-R
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Time between voids during conditional SNM

  Time between voids will be measured to determine change in conditional SNM response compared to baseline (no stimulation). Outcome will be measured from participant reporting and catheter- and device-referenced bladder pressures. For participant reporting (for example when voiding in a private bathroom) the clock time will be recorded and number of seconds from previous void will be recorded. For catheter- and device-referenced bladder pressures, the time between voids will be calculated manually by study staff from peak detrusor pressure during voiding contractions. When catheter recordings are available, these will be used as the sole source for measurement as they are the gold standard in urodynamic evaluation. All time data (in seconds) will be pooled for analysis. This outcome is powered for feasibility demonstration only.

  Through study completion, an average of 2 weeks

• Detrusor contraction period during conditional SNM

  Detrusor contraction period will be measured to determine change in conditional SNM response compared to baseline (no stimulation). Outcome will be measured from catheter- and device-referenced bladder pressures. The period between identified detrusor contractions will be measured in seconds by study staff in post-hoc analysis. When catheter recordings are available, these will be used as the sole source for measurement as they are the gold standard in urodynamic evaluation. All period data (in seconds) will be pooled for analysis. This outcome is powered for feasibility demonstration only.

  Through study completion, an average of 2 weeks

• Voided urine volume during conditional SNM

  Voided urine volume will be measured to determine change in conditional SNM response compared to baseline (no stimulation). Outcome will be measured from collected voided urine. This outcome is powered for feasibility demonstration only.

  Through study completion, an average of 2 weeks

Secondary Outcomes (5)

• Time between voids during continuous SNM

  Through study completion, an average of 2 weeks

• Feasibility of UroMonitor evaluation

  Through study completion, an average of 2 weeks

• Urinary incontinence symptom reduction during SNM evaluation

  Through study completion, an average of 2 weeks

• Urinary voiding frequency reduction during SNM evaluation

  Through study completion, an average of 2 weeks

• Urinary leakage frequency reduction during SNM evaluation

  Through study completion, an average of 2 weeks

Study Arms (2)

Conditional SNM

This group receives conditional sacral neuromodulation, applied intermittently based on sensor data describing bladder activity.

Device: UroMonitor; Device: ASCU

Continuous SNM

This group receives continuous SNM, applied constantly throughout the bladder filling cycle.

Device: UroMonitor

Interventions

UroMonitor DEVICE

The UroMonitor is small wireless sensor that is temporarily inserted into the bladder. While in the bladder it transmits bladder pressure measurements to an external radio. After a short period of use it is removed using an extraction string and discarded.

Conditional SNM; Continuous SNM

ASCU DEVICE

The ASCU is a wearable nerve stimulator containing a radio and computer processor. It receives pressure information from the bladder and determines when to turn on sacral nerve stimulation. It is only used temporarily during research visits.

Also known as: Application Specific Control Unit

Conditional SNM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll 16 patients undergoing treatment at the VANEOHS (US Veterans). Participants will have a diagnosis of neurogenic bladder with a recent (within one year) multi-channel UDS evaluation. Participants will be selected as those with neurogenic bladder symptoms most likely to respond to SNM treatment based on evidence-based recommendations (i.e reasonable bladder capacity, non-catheter dependent, ability to identify and manage bladder needs - as based upon assessment by clinical experts / co-investigators). Participants will be screened to meet inclusion/exclusion criteria. Implantation of bilateral percutaneous stimulating electrodes, setting of SNM stimulation waveforms, and the use of an external continuous SNM stimulator will follow clinical standard of care for prospective evaluation for Medtronic Interstim treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

Related Links

• VA Advanced Platform Technology Center

Biospecimen

Retention: NONE RETAINED

Urine sample tested for urinary tract infection

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases

Study Officials

• Steve J Majerus, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve J Majerus, PhD

CONTACT

(216) 791-3800; Steve.Majerus@va.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 2, 2021
• Study Start: October 3, 2022
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)