Recruiting

Triggered Sacral Neuromodulation

Sponsor:

VA Office of Research and Development

Code:

NCT05141487

Conditions

Urinary Incontinence

Urinary Bladder, Neurogenic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

UroMonitor

ASCU

Study Details

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

Study ID

NCT05141487

Start date

Oct 3, 2022

Status verified date

Jan, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Interventions and Outcome Measures

Arms

Conditional SNM

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

Continuous SNM

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

Interventions

UroMonitor

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.

ASCU

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.

Primary outcome measure

  • Time between voids during conditional SNM [ Time Frame: Through study completion, an average of 2 weeks ]
  • Detrusor contraction period during conditional SNM [ Time Frame: Through study completion, an average of 2 weeks ]
  • Voided urine volume during conditional SNM [ Time Frame: Through study completion, an average of 2 weeks ]

Central Contacts and Locations

Central contacts

Steve J Majerus, PhD

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

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Steve J Majerus, PhD

216-791-3800Steve.Majerus@va.gov

Principal Investigator:

Steve J Majerus, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-15.