One of the major goals of this project is to determine the long term effects and outcomes including complications of the' most commonly used surgical procedures for urinary incontinence. Extensive review of the literature shows that the success rate (continence) and improvement rate appear to be similar among all of the three surgical techniques proposed in this CTC. Although the complications may be more unique with one or the other, it also appears that the morbidity rate is similar. Therefore, we do not believe that a power calculation can be performed to estimate the total number of subjects needed to be enrolled in each group. Therefore, we believe that the total number of subjects may have to be arbitrarily decided by the network to assure an adequate number of patients to be observed to gather all the necessary information to satisfy the objectives of this study. The principal goal of incontinence therapy is to improve the quality of life for the patient. Patient satisfaction in long-term follow-up has not been adequately reported in the literature. This study can provide the extensive review of these issues. However, the criteria on which the comparisons are made will necessarily be agreed upon by the collective investigators. In addition, the economics of the proposed procedures will also have a bearing on the overall medicoeconomic outcomes. Due to the similarities between the reported treatment success rates, differences in long term cost effectiveness and ultimate patient satisfaction may be a better predictor of overall treatment success than improvement of incontinence symptoms alone.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK058231-01
Application #
6189817
Study Section
Special Emphasis Panel (ZDK1-GRB-B (M1))
Program Officer
Kusek, John W
Project Start
2000-09-30
Project End
2005-06-30
Budget Start
2000-09-30
Budget End
2001-06-30
Support Year
1
Fiscal Year
2000
Total Cost
$245,824
Indirect Cost
Name
William Beaumont Hospital
Department
Type
DUNS #
City
Royal Oak
State
MI
Country
United States
Zip Code
48073
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Brubaker, Linda; Litman, Heather J; Kim, Hae-Young et al. (2015) Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women. Int Urogynecol J 26:1155-9
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