NCT06170450

Cyclic Versus Continuous Sacral Neuromodulation for LUTS

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DEVICE	Cyclic SNM	SNM cycling: 8 hours on, 16 hours off
DEVICE	Continuous SNM	Continuous SNM: on continuously, no 'off' period

Timeline

• Start date: 2024-04-15
• Primary completion: 2026-05-01
• Completion: 2030-06-01
• First posted: 2023-12-14
• Last updated: 2025-05-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study