Journal article
Refractory urge urinary incontinence and botulinum a injection: the methods of the RUBI trial
The journal of applied research, Vol.6(4), pp.260-271
12/01/2006
Abstract
Objective: The purpose of this study was to describe the methods of a randomized clinical trial of intra-vesical botulinum toxin for refractory urge urinary incontinence. Methods: Clinical sites of the Pelvic Floor Disorders Network (www.pfdn.org) recruited patients with refractory urge urinary incontinence and urodynamic evidence of detrusor overactivity incontinence (DOI) to a 2:1 placebo controlled cystoscopic injection of botulinum toxin A. Results: The primary outcome is time to failure after first injection, with failure defined as a Patient Global Impression of Improvement (PGI-I) score 4 or greater at least 2 months after the first injection or the commencement of any new treatment at any time after the first injection, or an increased intensity of previously established treatment for DOI. Conclusions: This trial was designed to test the efficacy of intra-detrusor botulinum toxin A for the treatment of refractory urge incontinence. Progress of the trial can be monitored on www.clinicaltrials.gov.
Details
- Title: Subtitle
- Refractory urge urinary incontinence and botulinum a injection: the methods of the RUBI trial
- Creators
- Linda BrubakerKarl KrederHolly E RichterJohn LavelleJohn T WeiSangeeta MahajanAnne M Weber
- Resource Type
- Journal article
- Publication Details
- The journal of applied research, Vol.6(4), pp.260-271
- Publisher
- Therapeutic Solutions LLC
- ISSN
- 1537-064X
- eISSN
- 2374-7285
- Language
- English
- Date published
- 12/01/2006
- Description audience
- Academic
- Academic Unit
- Obstetrics and Gynecology; Urology
- Record Identifier
- 9984384351802771
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