Cyclic Versus Continuous Sacral Neuromodulation for LUTS

Study Overview
=================
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, and 12 months post-op.

Official Title
-----------------
CYclic Versus Continuous Sacral Modulation for LowEr Urinary Tract Symptoms: a Prospective Randomized Controlled Trial (CYCLE Trial)

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Device: Cyclic SNM
* Device: Continuous SNM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclic SNM<br>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. | Device: Cyclic SNM<br>* SNM cycling: 8 hours on, 16 hours off<br>|
| Active Comparator: Continuous SNM<br>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) | Device: Continuous SNM<br>* Continuous SNM: on continuously, no 'off' period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months 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. | Baseline, 1 month, 6 months, 12 months post-operatively |