Abstract | PURPOSE: MATERIALS AND METHODS: This was a single-blind, randomized, prospective, 33-center, 2-arm parallel study of hydrogel vs collagen gel with followup to 1 year. At baseline patients underwent physical examination and bladder testing, and completed quality of life questionnaires and bladder diaries. After randomization patients could receive up to 3 injections at 1-month intervals. Patients were assessed 3, 6, 9 and 12 months after bulking. They completed bladder diaries and quality of life questionnaires, and pad weight was tested. At the last visit Valsalva leak point pressure was measured. Subjective and objective incontinence outcomes and adverse events were compared. RESULTS: Of the 345 women 229 were randomized to hydrogel and 116 were randomized to collagen gel. At 12 months a 50% or greater decrease in leakage and incontinence episodes was seen in 53.2% and 55.4% of patients who received hydrogel and collagen gel, respectively. At 12 months 47.2% of patients with hydrogel and 50% with collagen gel reported zero stress incontinence episodes, and 77.1% and 70%, respectively, considered themselves cured or improved. Major adverse events were rare in each group. CONCLUSIONS:
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Authors | Eric R Sokol, Mickey M Karram, Roger Dmochowski |
Journal | The Journal of urology
(J Urol)
Vol. 192
Issue 3
Pg. 843-9
(Sep 2014)
ISSN: 1527-3792 [Electronic] United States |
PMID | 24704117
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Acrylic Resins
- Biocompatible Materials
- Bulkamid
- Hydrogels
- glutaraldehyde-cross-linked collagen
- polyacrylamide gels
- Collagen
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Topics |
- Acrylic Resins
(adverse effects, therapeutic use)
- Adult
- Aged
- Aged, 80 and over
- Biocompatible Materials
(therapeutic use)
- Canada
- Collagen
(therapeutic use)
- Female
- Humans
- Hydrogels
(adverse effects, therapeutic use)
- Middle Aged
- Prospective Studies
- Quality of Life
- Single-Blind Method
- Surveys and Questionnaires
- Treatment Outcome
- United States
- Urinary Incontinence, Stress
(therapy)
- Young Adult
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