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: Completed
• 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, 12 months, 3 years, and 5 years post-op.

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

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals
    • Cleveland, Ohio, United States, 44109
      • MetroHealth

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. Score ranges 25-160 points with greater value indicating increased impact on quality of life.	Baseline to 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. Score ranges 25-160 points with greater value indicating increased impact on quality of life	1 month, 6 months 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. Scores range 3- 36, higher values indicating increased symptom severity	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. Scores range 0-15 with higher scores indicating higher severity.	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. Scores range 0-100 (raw score multiplied by 33 1/3 to transform scale) with higher scores indicating higher bother	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. Scores 6 items, range 0-100 (raw score multiplied by 33 1/3 to transform scale) with higher scores indicating higher distress.	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 4-point scale designed to assess for disease severity where 1 indicates "normal," 2 is "mild," 3 is "moderate," and 4 is "severe." Outcome measured is number of participants per group who reported disease is "severe" at each timepoint.	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 with answer choices: Very much better, Much better, A little better, No change, A little worse, Much worse, Very much worse. Outcome measure includes number of participants per group who reported "very much better" or "much better" at each timepoint	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. Score range 0-100 with higher scores indicating greater treatment satisfaction	1 month, 6 months, 12 months post-operatively
Change in Voiding Episodes Per Day	Patients will use 3 days bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes per day. Daily voiding frequency will be the voiding episodes per day averaged over 3 day bladder diary.	1 month, 6 months, 12 months post-operatively
Change in Voiding Episodes Per Night	Patients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes. Voiding episodes per night will be voiding episodes per night averaged over 3 day bladder diary.	1 month, 6 months, 12 months post-operatively
Change in Pads Per Day	Patients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes. Pads per day will be the pad count per day averaged over 3 day bladder diary.	1 month, 6 months, 12 months post-operatively
Change in Urge Incontinence Episodes Per Day	Patients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pad count per day, and urge incontinence episodes per day. Urge incontinence episodes will be the urge incontinence episodes per day averaged over 3 day bladder diary.	1 month, 6 months, 12 months post-operatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): May 12, 2026
• Study Completion (Actual): May 12, 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 (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder 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