Cyclic Versus Continuous Sacral Neuromodulation for LUTS

NCT06170450 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STUDY20231521
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in ICIQ-OAB-QoL score

  Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively

• Change in OAB-q SF

  Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively

• Change in Overactive Bladder Symptom Score (OABSS)

  Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively

• Change in Incontinence Impact Questionnaire SF (IIQ-7)

  Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively

• Urinary Distress Inventory SF (UDI-6)

  Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively

Study Arms (2)

Cyclic SNM

EXPERIMENTAL

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

Continuous SNM

ACTIVE COMPARATOR

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

Interventions

Cyclic SNM DEVICE

SNM cycling: 8 hours on, 16 hours off

Cyclic SNM

Continuous SNM DEVICE

Continuous SNM: on continuously, no 'off' period

Continuous SNM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Northwestern University: collaborator
• University of Louisville: collaborator
• Metro Health, Michigan: collaborator

Study Sites (3)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

MetroHealth

Cleveland, Ohio, 44109, United States

Location

Study Officials

• David Sheyn, MD

  UH Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: April 15, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available during study recruitment and monitoring. When study has concluded, data will no longer be available.
• Access Criteria: Available to only (IRB approved) members of study team through secure RedCap

Locations

US (3)