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Study Title and Description

A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women
Author Campeau L, Tu LM, Lemieux MC, Naud A, Karsenty G, Schick E, Corcos J
Country --
Year 2007
Numbers Pubmed ID: 17638307
2250 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Canada
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Sling Category Retropubic synthetic
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Multicenter? Yes
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training Urology
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Residents or Fellows Performing the Surgery? Yes
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Adverse Event Ascertainment Active
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Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding Industry
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Follow-up time In-hospital or After discharge Is event serious? Reported definition of serious event Number affected Number at risk (analyzed) Difference between 2 slings (eg, OR/RR or %, with 95% CI) Reported P value between slings Comments
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bladder perforation Intra-op In-hospital ND ND 7 31 NA ND
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Retropubic synthetic Urinary retention PVR >150mL <6mo After discharge ND ND 4 31 NA ND
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Retropubic synthetic Obstruction requiring reoperation Urethral dilation/ mobilization 2 d postop After discharge ND ND 1 31 NA ND
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Retropubic synthetic Return to OR Opening incision and tape release 6 d postop After discharge ND ND 1 31 NA ND
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Retropubic synthetic De novo urgency Not defined and unclear if active or passive ascertainment 6 mo After discharge ND ND 1 31 NA ND
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Retropubic synthetic Infection, UTI Not defined Unclear After discharge ND ND 1 31 NA ND
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