Abstract | STUDY OBJECTIVE: DESIGN: Continuing, prospective, 36-month, open-label, single-arm clinical trial. Twelve-month results from intent-to-treat (ITT) analysis are reported. Canadian Task Force classification II-2. SETTING: Thirteen physician offices or ambulatory treatment centers. PATIENTS: Women with SUI secondary to bladder outlet hypermobility for 12 months or longer who failed earlier conservative treatment and had not received earlier surgical or bulking agent therapy. INTERVENTIONS: Women were treated as outpatients and received an oral antibiotic and local periurethral anesthesia before undergoing treatment with transurethral radiofrequency collagen denaturation. MEASUREMENTS AND MAIN RESULTS: Voiding diaries and in-office stress pad weight tests yield objective assessments. Subjective measures include the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement (PGI-I) instruments. In total, 136 women received treatment (ITT population). Patients experienced significant reductions versus baseline in median number of leaks caused by activity/day and activity/week (p <.0026 for both), with 50% of patients reporting 50% or more reduction. Pad weight tests revealed that 69% of women had 50% or more reduction in leakage (median reduction 15.2 g; p <.0001); 45% were dry (29% no leaks; 16% < 1-g leakage). Significant improvements occurred in median scores on the I-QOL (+9.5 [range -66.0 to 91.0]; p <.0001) and mean scores on the UDI-6 (-14.1 +/- 24.7; p <.0001). Furthermore, 71.2% showed I-QOL score improvement, including 50.3% with 10-point or greater improvement, and 49.6% reported on the PGI-I that they were "a little," "much," or "very much" better. CONCLUSION: At 12 months, treatment of SUI with nonsurgical transurethral collagen denaturation resulted in significant improvements in activity-related leaks and quality of life.
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Authors | Denise M Elser, Gretchen K Mitchell, John R Miklos, Kevin G Nickell, Kevin Cline, Harvey Winkler, W Glen Wells |
Journal | Journal of minimally invasive gynecology
(J Minim Invasive Gynecol)
2009 Jan-Feb
Vol. 16
Issue 1
Pg. 56-62
ISSN: 1553-4650 [Print] United States |
PMID | 19013110
(Publication Type: Clinical Trial, Journal Article, Multicenter Study)
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Chemical References |
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Collagen
(radiation effects)
- Diathermy
(methods)
- Female
- Humans
- Longitudinal Studies
- Middle Aged
- Patient Satisfaction
- Prospective Studies
- Protein Denaturation
- Treatment Outcome
- Urinary Bladder, Overactive
(therapy)
- Urinary Incontinence, Stress
(therapy)
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