Cycling Versus Continuous Mode in Neuromodulator Programming
Completed · Not applicable
Conditions studied: Urinary Incontinence, Urge
In brief
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.
Key facts
- Study ID
- NCT02551822
- Run by
- University of New Mexico
- People needed
- 32
- Starts
- 2012-07-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2018-04-27
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women at least 21 years old or older eligible for implantation of a neuromodulator
- Women with successful Stage #1 implantation for treatment of refractory OAB
- Subjects may be enrolled in other studies as long as there are no changes to the neuromodulation device. Women may continue other OAB therapies that they are on, but as asked to not start new therapies.
- Not currently pregnant and with no plans to become pregnant during the course of the trial.
- Willing as well as mentally and physically capable of completing all study related procedures and materials
You may not qualify if…
- Males (we do not care for males in our urogynecology clinic)
- Incarcerated women
- Non-English speakers
- Pregnant women
- Scheduled or planned MRIs or diathermy
Where it is running
- University of New Mexico Hospital — Albuquerque, New Mexico, United States
- University of New Mexico Health Science Center — Albuquerque, New Mexico, United States
Full record on ClinicalTrials.gov
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