Cyclic Versus Continuous Sacral Neuromodulation for LUTS

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

This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Device: Cyclic SNM; Device: Continuous SNM

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Sheyn, MD; Email: David.Sheyn@uhhospitals.org
• Study Contact Backup: Name: Margot Le Neveu, MD; Phone Number: 2168443722; Email: Margot.LeNeveu@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Cyclic SNM; SNM cycling: 8 hours on, 16 hours off
Active Comparator: 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)	Device: Continuous SNM; Continuous SNM: on continuously, no 'off' period

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

Collaborators and Investigators

• Sponsor: David Sheyn
• Collaborators: Northwestern University; University of Louisville
• Investigators: Principal Investigator: David Sheyn, MD, UH Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: STUDY20231521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only de-identified data will be shared with co-collaborators at Northwestern University (PI: Carol E. Bretschneider) and University of Louisville (PI: Ankita Gupta)
• IPD Sharing Time Frame: Data will be available during study recruitment and monitoring. When study has concluded, data will no longer be available.
• IPD Sharing Access Criteria: Available to only (IRB approved) members of study team through secure RedCap
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No