This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
SNM cycling: 8 hours on, 16 hours off
Continuous SNM: on continuously, no 'off' period
University of Louisville
Louisville, Kentucky, United States
University Hospitals
Cleveland, Ohio, United States
MetroHealth
Cleveland, Ohio, United States
Change in ICIQ-OAB-QoL score
ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder.
Time frame: Baseline, 12 months post-operatively
Change in ICIQ-OAB-QoL score
ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Change in OAB-q SF
OAB-q SF is a 19 question patient-completed survey evaluating symptom bother and quality of life in patients with overactive bladder.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Change in Overactive Bladder Symptom Score (OABSS)
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.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Change in Incontinence Impact Questionnaire SF (IIQ-7)
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.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Urinary Distress Inventory SF (UDI-6)
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.
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Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Patient Global Impression of Severity (PGI-S)
Patient Global Impression of Severity (PGI-S) is a 1-item scale designed to assess for disease severity.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Patient Global Impression of Improvement (PGI-I)
Patient Global Impression of Improvement (PGI-I) is a 1-item scale designed to assess symptom improvement.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Overactive Bladder Satisfaction of Treatment Questionnaire
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.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Change in voiding frequency (# of voiding episodes in 24 hours)
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.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Change in nocturia episodes
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.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Change in urgency episodes
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.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Change in urinary urge incontinence episodes
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.
Time frame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively