Urinary IncontinenceNCT05141487
Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
An observational study of Urinary Incontinence and Urinary Bladder, Neurogenic, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Urinary Bladder, Neurogenic
- What is being tested?
- UroMonitor and ASCU
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Steve J Majerus, PhD, 216-791-3800, Steve.Majerus@va.gov
Steve J Majerus, PhD
About this study
Official title: Triggered Sacral Neuromodulation to Treat Neurogenic Detrusor Overactivity Based on Algorithmic Classification of Bladder Filling Status From Wireless Pressure Data
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.
Read the detailed description
Neurogenic detrusor overactivity (NDO) resulting from spinal cord injury or disorder (SCI/D) affects 80% of individuals with SCI/D. It is also associated with peripheral neurodegenerative conditions such as Parkinson's disease, multiple sclerosis, diabetic neuropathy, or stroke. NDO causes urinary incontinence that profoundly impacts dignified, independent living, associates with numerous comorbidities and fall risk, and is a leading factor in functional decline among the elderly. Urinary incontinence contributes to social isolation and clinical depression and associates with military service and post-traumatic stress disorder in Veterans.
Restoring urine storage is consistently cited as a high priority by individuals with NDO. Continuous SNM is an off-label treatment, which is effective for some individuals with NDO. Triggered sacral neuromodulation-in which SNM is applied only during the portion of the bladder fill cycle where NDO occurs-could show unique benefit in treatment in some individuals. While triggered SNM increased bladder capacity in sheep and rats, feasibility has not yet been demonstrated in humans with NDO.
The primary goal of this research is to demonstrate the feasibility of increasing bladder capacity and reducing bladder filling pressures using triggered SNM in Veterans with NDO. This will expand on unique technologies developed by the research team: the UroMonitor, the Context-Aware Threshold (CAT) algorithm, and the Application Specific Control Unit (ASCU). The UroMonitor is a small, transurethrally-inserted sensor that wirelessly transmits bladder pressure data. CAT is a wavelet-based algorithm that detects detrusor contractions from pressure data in real time. The ASCU is a modular neurostimulation platform supporting wireless communication and custom control software. The investigators will modify and integrate these technologies to demonstrate the feasibility of automatically triggering SNM in Veterans. A secondary goal is to use the UroMonitor to determine bladder capacity, detrusor contraction rate, and filling pressures during a percutaneous SNM evaluation to identify individuals who respond to SNM therapy before a permanent implantation.
Both translational goals will be accomplished through two Specific Aims (SA):
SA1 will determine the change in bladder response to conditionally-triggered SNM during natural filling cycles after a two-week sacral neuromodulation evaluation phase in Veterans with NDO. The investigators will apply triggered SNM using data transmitted from the UroMonitor to the ASCU. Triggered SNM will be applied for up to eight hours at three timepoints in the two-week percutaneous evaluation phase in eight Veterans. Voided urine volume, time between voids, and detrusor contraction frequency will be compared to determine change in conditional SNM response at the two timepoints and compared to baseline. Outcome measures will be measured from validated questionnaires, catheter-referenced bladder pressures, and collected voided urine.
SA2 will determine change in bladder capacity, filling pressure, and detrusor contraction frequency during natural filling cycles throughout a two-week continuous sacral neuromodulation evaluation. The investigators will demonstrate the feasibility of using the UroMonitor to characterize NDO symptoms (bladder capacity, filling pressure, and detrusor contraction rate) over several bladder filling/emptying cycles. Eight Veterans will receive standard, continuous percutaneous SNM for two weeks. NDO symptoms will be measured using the UroMonitor before SNM and after one and two weeks of continuous SNM. Accuracy of symptom quantification will be compared to standard catheter-based testing and validated urinary behavior questionnaires.
- Conditions
- Urinary Incontinence, Urinary Bladder, Neurogenic
- Being tested
- UroMonitor, ASCU
- Keywords
- Urinary Bladder, Neurogenic, Electric Stimulation, Transcutaneous Electric Nerve Stimulation
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroMonitorDevice
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.
ASCUDevice
Also called Application Specific Control Unit
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.
| Study group | Role | What they receive |
|---|---|---|
| Conditional SNM | This group receives conditional sacral neuromodulation, applied intermittently based on sensor data describing bladder activity. Receives: Device: UroMonitor; Device: ASCU | |
| Continuous SNM | This group receives continuous SNM, applied constantly throughout the bladder filling cycle. Receives: Device: UroMonitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 weeks
Secondary outcomes (5)
Time between voids during continuous SNM
Time between voids will be measured to determine change in continuous 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.
Measured: Through study completion, an average of 2 weeks
Feasibility of UroMonitor evaluation
A secondary goal is to use the UroMonitor to objectively monitor change in bladder behavior during a standard percutaneous SNM evaluation. Feasibility will be assessed by participant discomfort score on the range of 0-5 during UroMonitor use, with higher values indicating more discomfort. This outcome is powered for feasibility demonstration only.
Measured: Through study completion, an average of 2 weeks
Urinary incontinence symptom reduction during SNM evaluation
Participant response to SNM at one- and two-week timepoints will be compared to baseline (no SNM) urinary incontinence symptom scores (range of 0-78, higher scores reflect worse symptoms). Symptom reduction will be evaluated by the validated neurogenic bladder symptom score questionnaire. This outcome is powered for feasibility demonstration only.
Measured: Through study completion, an average of 2 weeks
Urinary voiding frequency reduction during SNM evaluation
Participant response to SNM at one- and two-week timepoints will be compared to baseline (no SNM) voiding frequency. Symptom reduction will be evaluated from participant-provided urinary diary. The voiding frequency (number of voids per 24 hours) will be calculated. Voiding frequency will be independently calculated per participant per day. This outcome is powered for feasibility demonstration only.
Measured: Through study completion, an average of 2 weeks
Urinary leakage frequency reduction during SNM evaluation
Participant response to SNM at one- and two-week timepoints will be compared to baseline (no SNM) leakage frequency. Symptom reduction will be evaluated from participant-provided urinary diary. The leak frequency (number of leaks per 24 hours) will be calculated. Leak frequency will be independently calculated per participant per day. This outcome is powered for feasibility demonstration only.
Measured: Through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start3 Oct 2022
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steve J Majerus, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141487
- Sponsor's protocol ID
- A3687-R
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 2021
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triggered Sacral Neuromodulation to Treat Neurogenic Detrusor Overactivity Based on Algorithmic Classification of Bladder Filling Status From Wireless Pressure Data
- ClinicalTrials.gov ID
- NCT05141487
- Acronym / sponsor ID
- A3687-R
- Conditions
- Urinary Incontinence, Urinary Bladder, Neurogenic
- Keywords
- Urinary Bladder, Neurogenic, Electric Stimulation, Transcutaneous Electric Nerve Stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neurogenic detrusor overactivity (NDO) resulting from spinal cord injury or disorder (SCI/D) affects 80% of individuals with SCI/D. It is also associated with peripheral neurodegenerative conditions such as Parkinson's disease, multiple sclerosis, diabetic neuropathy, or stroke. NDO causes urinary incontinence that profoundly impacts dignified, independent living, associates with numerous comorbidities and fall risk, and is a leading factor in functional decline among the elderly. Urinary incontinence contributes to social isolation and clinical depression and associates with military service and post-traumatic stress disorder in Veterans.
Restoring urine storage is consistently cited as a high priority by individuals with NDO. Continuous SNM is an off-label treatment, which is effective for some individuals with NDO. Triggered sacral neuromodulation-in which SNM is applied only during the portion of the bladder fill cycle where NDO occurs-could show unique benefit in treatment in some individuals. While triggered SNM increased bladder capacity in sheep and rats, feasibility has not yet been demonstrated in humans with NDO.
The primary goal of this research is to demonstrate the feasibility of increasing bladder capacity and reducing bladder filling pressures using triggered SNM in Veterans with NDO. This will expand on unique technologies developed by the research team: the UroMonitor, the Context-Aware Threshold (CAT) algorithm, and the Application Specific Control Unit (ASCU). The UroMonitor is a small, transurethrally-inserted sensor that wirelessly transmits bladder pressure data. CAT is a wavelet-based algorithm that detects detrusor contractions from pressure data in real time. The ASCU is a modular neurostimulation platform supporting wireless communication and custom control software. The investigators will modify and integrate these technologies to demonstrate the feasibility of automatically triggering SNM in Veterans. A secondary goal is to use the UroMonitor to determine bladder capacity, detrusor contraction rate, and filling pressures during a percutaneous SNM evaluation to identify individuals who respond to SNM therapy before a permanent implantation.
Both translational goals will be accomplished through two Specific Aims (SA):
SA1 will determine the change in bladder response to conditionally-triggered SNM during natural filling cycles after a two-week sacral neuromodulation evaluation phase in Veterans with NDO. The investigators will apply triggered SNM using data transmitted from the UroMonitor to the ASCU. Triggered SNM will be applied for up to eight hours at three timepoints in the two-week percutaneous evaluation phase in eight Veterans. Voided urine volume, time between voids, and detrusor contraction frequency will be compared to determine change in conditional SNM response at the two timepoints and compared to baseline. Outcome measures will be measured from validated questionnaires, catheter-referenced bladder pressures, and collected voided urine.
SA2 will determine change in bladder capacity, filling pressure, and detrusor contraction frequency during natural filling cycles throughout a two-week continuous sacral neuromodulation evaluation. The investigators will demonstrate the feasibility of using the UroMonitor to characterize NDO symptoms (bladder capacity, filling pressure, and detrusor contraction rate) over several bladder filling/emptying cycles. Eight Veterans will receive standard, continuous percutaneous SNM for two weeks. NDO symptoms will be measured using the UroMonitor before SNM and after one and two weeks of continuous SNM. Accuracy of symptom quantification will be compared to standard catheter-based testing and validated urinary behavior questionnaires.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conditional SNM | – | Device: UroMonitor, Device: ASCUThis group receives conditional sacral neuromodulation, applied intermittently based on sensor data describing bladder activity. |
| Continuous SNM | – | Device: UroMonitorThis group receives continuous SNM, applied constantly throughout the bladder filling cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UroMonitorThe 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. | Device | Conditional SNM, Continuous SNM |
| ASCUAlso: Application Specific Control UnitThe 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. | Device | Conditional SNM |
Primary outcome
Time between voids during conditional SNM
Time frame: Through study completion, an average of 2 weeks
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.
Detrusor contraction period during conditional SNM
Time frame: Through study completion, an average of 2 weeks
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.
Voided urine volume during conditional SNM
Time frame: Through study completion, an average of 2 weeks
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.
5 secondary outcomes
Time between voids during continuous SNM
Time frame: Through study completion, an average of 2 weeks
Feasibility of UroMonitor evaluation
Time frame: Through study completion, an average of 2 weeks
Urinary incontinence symptom reduction during SNM evaluation
Time frame: Through study completion, an average of 2 weeks
Urinary voiding frequency reduction during SNM evaluation
Time frame: Through study completion, an average of 2 weeks
Urinary leakage frequency reduction during SNM evaluation
Time frame: Through study completion, an average of 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- VA Advanced Platform Technology CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steve J Majerus, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Urinary Bladder, Neurogenic, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steve J Majerus, PhD ((216) 791-3800, Steve.Majerus@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between voids during conditional SNM (time frame: Through study completion, an average of 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.