Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active urinary tract infection
Chronic indwelling or suprapubic catheter usage
Severe or rapidly progressive neurologic disease
Abnormal sacral anatomy
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
UroMonitor
DeviceThe 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
DeviceThe 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.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Conditional SNM2 interventions
Group B: Continuous SNM1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 2 weeks2
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.
Time frame
Through study completion, an average of 2 weeks3
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.
Time frame
Through study completion, an average of 2 weeksSecondary outcomes
1
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.
Time frame
Through study completion, an average of 2 weeks2
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.
Time frame
Through study completion, an average of 2 weeks3
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.
Time frame
Through study completion, an average of 2 weeks4
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.
Time frame
Through study completion, an average of 2 weeksSponsors and contacts
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Source ClinicalTrials.gov