Cyclic Versus Continuous Sacral Neuromodulation for LUTS
- Conditions
- Overactive Bladder Syndrome
- Interventions
- Device: Cyclic SNMDevice: Continuous SNM
- Registration Number
- NCT06170450
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- Brief Summary
This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.
- Detailed Description
Overactive bladder (OAB) is characterized by urinary frequency, urgency, incontinence, and nocturia in the absence of other pathology. AUA guidelines recommend trial of sacral neuromodulation (SNM) for patients with refractory OAB who have failed treatment with behavioral modification and medication. SNM settings are typically selected based on discussion between the patient and device representative. There is a paucity of rigorous data assessing optimal SNM stimulation programming for symptomatic improvement.
This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) in patients undergoing SNM for OAB.
Patients \> age 18 with a diagnosis of refractory OAB being scheduled for a trial of SNM (either stage I lead/temporary battery placement or office peripheral nerve evaluation) will be approached by study personnel during their clinic visit or by a phone call to determine if they are interested in participating in the programming study.
Patients interested in participating will provide written informed consent. After informed consent is obtained, a baseline evaluation will be performed. This includes history, 3-day voiding diary (# voiding episodes, # nocturia episodes, # urge incontinence episodes/24h), urinalysis, urine culture (if indicated), post void residuals, and symptom assessments using questionnaires.
Only those with successful trial and eligible/ interested in permanent SNM placement will participate in this trial. Randomization will occur after stage 2/ full permanent implantation when the neuromodulator is being programmed in the recovery room. Patients will be randomly assigned to either continuous stimulation or cyclic stimulation.
Patients will then be followed with clinical evaluation and questionnaires repeated at 1 month, 6 months, 12 months, 3 years, and 5 years post-op.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- Patients 18 years of age or older
- Female
- English Speaking
- Diagnosis of urinary urge incontinence or overactive bladder
- Meet criteria for and are planning permanent SNM (ie. successful stage I or office PNE trial of SNM with 50% or more reduction in UUI episodes)
- Willing and able to complete all study related items
- Patients less than 18 years of age
- Unable to provide consent
- Non-English speaking
- Relevant neurologic diseases (multiple sclerosis, Parkinson Disease, myasthenia gravis, - - - Charcot-Marie-Tooth disease, complete spinal cord injury)
- Current or prior bladder malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cyclic SNM Cyclic SNM Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode. Continuous SNM Continuous SNM Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
- Primary Outcome Measures
Name Time Method Change in ICIQ-OAB-QoL score Baseline, 12 months post-operatively ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder.
- Secondary Outcome Measures
Name Time Method Change in OAB-q SF Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively OAB-q SF is a 19 question patient-completed survey evaluating symptom bother and quality of life in patients with overactive bladder.
Change in Overactive Bladder Symptom Score (OABSS) Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively The Overactive Bladder Symptom Score (OABSS) is a 4 question validated symptom assessment tool for patients with OAB and assesses number of episodes of frequency, nocturia, urgency, and urge incontinence.
Change in voiding frequency (# of voiding episodes in 24 hours) Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Daily voiding frequency will be the average # of voids per 24h averaged over 3 day bladder diary.
Change in urgency episodes Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Urgency episodes will be the average # of urgency episodes per 24h averaged over 3 day bladder diary.
Change in ICIQ-OAB-QoL score Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder.
Change in Incontinence Impact Questionnaire SF (IIQ-7) Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Incontinence Impact Questionnaire SF (IIQ-7) is a 7-item validated questionnaire that assesses urinary symptoms, the symptom bother, and the impact the bother has on patients' quality of life using a 4-point bother scale.
Patient Global Impression of Severity (PGI-S) Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Patient Global Impression of Severity (PGI-S) is a 1-item scale designed to assess for disease severity.
Patient Global Impression of Improvement (PGI-I) Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Patient Global Impression of Improvement (PGI-I) is a 1-item scale designed to assess symptom improvement.
Urinary Distress Inventory SF (UDI-6) Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Urinary Distress Inventory SF (UDI-6) is a 6 item validated questionnaire that assesses urinary symptoms, the symptom bother, and the impact the bother has on patients' quality of life using a 4-point bother scale.
Overactive Bladder Satisfaction of Treatment Questionnaire Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Change in Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SAT-q) is an 11-item validated questionnaire that assesses patients' satisfaction with their OAB treatment within a clinical setting from baseline.
Change in nocturia episodes Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Nocturia episodes will be the average # of voids overnight per day averaged over 3 day bladder diary.
Change in urinary urge incontinence episodes Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Urinary urge incontinence episodes will be the average # of urinary urge incontinence episodes per 24h averaged over 3 day bladder diary.
Trial Locations
- Locations (3)
University of Louisville
🇺🇸Louisville, Kentucky, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
MetroHealth
🇺🇸Cleveland, Ohio, United States