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Cycling Versus Continuous Mode in Neuromodulator Programming

NCT02551822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-04-27

Study results available
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Summary

The investigators objective is to compare patient outcomes as changes in validated symptom measures of overactive bladder, the Overactive Bladder Questionnaire Short Form (OABq-SF) symptom scale, between women who are set on cycling versus continuous programs for their neuromodulator. Specifically, the investigators propose to perform a randomized double blind crossover study in women who are successfully treated with neuromodulation to either continuous or cycling mode on the modulator and compare differences between groups on the validated OABq-SF symptom questionnaire. In addition, the investigators will compare differences in urinary frequency and pad counts between women randomized to cycling versus continuous stimulation as measured by a 3 day voiding diary. This investigation will provide evidence-based guidelines for neuromodulator programming.

Conditions

  • Urinary Incontinence, Urge

Interventions

DEVICE

sacral neuromodulator

The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.

Sponsors & Collaborators

  • Society of Urologic Nurses and Associates

    collaborator UNKNOWN

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Yuko M Komesu, MD · University of New Mexico Health Sciences Center

  • Gwendolyn Beer, RN · University of New Mexico Health Sciences Center

  • Rebecca G Rogers, MD · University of New Mexico Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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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 NCT02551822 on ClinicalTrials.gov