Document Detail


Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence.
MedLine Citation:
PMID:  16673379     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Neurourology and urodynamics     Volume:  25     ISSN:  0733-2467     ISO Abbreviation:  Neurourol. Urodyn.     Publication Date:  2006  
Date Detail:
Created Date:  2006-08-25     Completed Date:  2006-10-10     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8303326     Medline TA:  Neurourol Urodyn     Country:  United States    
Other Details:
Languages:  eng     Pagination:  331-6     Citation Subset:  IM    
Affiliation:
Department of Urology, Baylor College of Medicine, Houston, Texas, USA.
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MeSH Terms
Descriptor/Qualifier:
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:
9007-34-5/Collagen

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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