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Cyclic Versus Continuous Sacral Neuromodulation for LUTS

NCT06170450 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-21

No results posted yet for this study

Summary

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

Conditions

  • Overactive Bladder Syndrome

Interventions

DEVICE

Cyclic SNM

SNM cycling: 8 hours on, 16 hours off

DEVICE

Continuous SNM

Continuous SNM: on continuously, no 'off' period

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

  • University of Louisville

    collaborator OTHER

  • Metro Health, Michigan

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • David Sheyn, MD · UH Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2026-05-31
Completion
2030-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06170450 on ClinicalTrials.gov