MedTrace Logo

Neuromodulation Implantation Settings Variation for Overactive Bladder

NCT02112786 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-01-26

No results posted yet for this study

Summary

Participants receiving neuromodulation treatment for overactive bladder symptoms will be routinely fitted with an impulse generator. However, the setting on the impulse generator will be set to either intermittent or continuous stimulation. Participants will complete voiding logs and surveys for a month. Battery life will be interrogated.After a one week period were the device is turned off, the impulse generator will be turned to the opposite setting (intermittent or continuous) and the one month period will be repeated. Again, voiding logs, surveys, and battery life will be collected.

The purpose of this project is to investigate the outcomes of intermittent versus continuous stimulation in patients treated with sacral neuromodulation (SNM) for refractory overactive bladder (OAB) syndrome. In addition, the potential for an improved battery life with intermittent stimulation will be quantified.

Conditions

Interventions

DEVICE

Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator

This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Andrea Staack, MD, Phd · Loma LindaUniversity Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02112786 on ClinicalTrials.gov