| Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. | |
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MedLine Citation:
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PMID: 16673379 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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AIMS: This prospective, randomized, controlled clinical trial was performed to demonstrate the 12 months safety and efficacy of transurethral radiofrequency energy (RF) collagen micro-remodeling in women with stress urinary incontinence (SUI). MATERIALS AND METHODS: Women with SUI, bladder outlet hypermobility, and leak point pressure (LPP) > or =60 cmH(2)O were randomized to RF micro-remodeling or "sham treatment." Adverse events (AEs) were recorded. Incidence of > or =10 point incontinence quality of life (I-QOL) score improvement, a magnitude of improvement with a demonstrated responsiveness to patient satisfaction with treatment and to > or =25% reduction in both incontinence episode frequency and stress pad weight, served as a subjective outcome measurement. Change in mean LPP served as an objective outcome measurement. RESULTS: 110 women underwent RF micro-remodeling and 63 underwent virtually identical "sham treatment" (with the exception of RF delivery). The 12 months RF micro-remodeling safety profile was statistically no different than that of sham treatment (a brief bladder catheterization). Seventy-four percent of women with moderate to severe baseline SUI experienced > or =10 point I-QOL score improvement at 12 months (P = 0.04). Women who underwent RF micro-remodeling demonstrated LPP elevation at 12 months, while sham treated women demonstrated LPP reduction (P = 0.02). CONCLUSIONS: Non-surgical, transurethral RF micro-remodeling is a safe treatment for women with SUI. In women with moderate to severe SUI, this novel therapy resulted in statistically significant improvement in quality of life of a magnitude associated with patient satisfaction with the treatment. Women who underwent RF micro-remodeling demonstrated a statistically significant elevation in mean LPP at 12 months. |
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Authors:
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Rodney A Appell; Saad Juma; W Glen Wells; John P Lenihan; Ira W Klimberg; Angelo Kanellos; Sandra F Reilley |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Neurourology and urodynamics Volume: 25 ISSN: 0733-2467 ISO Abbreviation: Neurourol. Urodyn. Publication Date: 2006 |
Date Detail:
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Created Date: 2006-08-25 Completed Date: 2006-10-10 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8303326 Medline TA: Neurourol Urodyn Country: United States |
Other Details:
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Languages: eng Pagination: 331-6 Citation Subset: IM |
Affiliation:
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Department of Urology, Baylor College of Medicine, Houston, Texas, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Catheter Ablation / adverse effects, instrumentation, methods* Collagen Female Humans Middle Aged Pressure Prospective Studies Quality of Life Treatment Outcome Urinary Incontinence, Stress / surgery* Urologic Surgical Procedures / adverse effects, instrumentation, methods* |
| Chemical | |
Reg. No./Substance:
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9007-34-5/Collagen |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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