Cyclic Versus Continuous Sacral Neuromodulation for LUTS

NCT ID: NCT06170450

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2030-06-30

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, 12 months, 3 years, and 5 years post-op.

Conditions

Overactive Bladder Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cyclic SNM

Intervention Type: DEVICE

SNM cycling: 8 hours on, 16 hours off

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)

Group Type: ACTIVE_COMPARATOR

Continuous SNM

Intervention Type: DEVICE

Continuous SNM: on continuously, no 'off' period

Interventions

Cyclic SNM

SNM cycling: 8 hours on, 16 hours off

Intervention Type: DEVICE

Continuous SNM

Continuous SNM: on continuously, no 'off' period

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: collaborator

Metro Health, Michigan

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Sheyn

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Sheyn, MD

Role: PRINCIPAL_INVESTIGATOR

UH Hospitals Cleveland Medical Center

Locations

University of Louisville

Louisville, Kentucky, United States

University Hospitals

Cleveland, Ohio, United States

MetroHealth

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

STUDY20231521

Identifier Type: -

Identifier Source: org_study_id