N/A
Completed N=23
Cycling Versus Continuous Mode in Neuromodulator Programming
Urinary Incontinence, Urge
Source: ClinicalTrials.gov NCT02551822 ↗
Enrolled (actual)
23
Serious AEs
2.2%
Results posted
Apr 2018
Primary outcomePrimary: Overactive Bladder Questionnaire-Short Form (OABq) Short Form Symptom Bother Scale Result — 68.3; 66.3; 30.3; 38.0 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overactive Bladder Questionnaire-Short Form (OABq) Short Form Symptom Bother Scale Result |
68.3; 66.3; 30.3; 38.0; 24.7; 53.3 | — |
| SECONDARY Voiding Diary: Urge Incontinence Episodes |
6.9; 8.1; -1.3; -2.9; -.35; -2.5 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Questionnaire Scale Results |
2.6; 2.6; 2.5; 2.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Males (we do not care for males in our urogynecology clinic)
- Incarcerated women
- Non-English speakers
- Pregnant women
- Scheduled or planned MRIs or diathermy
Data sourced from ClinicalTrials.gov (NCT02551822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.