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Study Title and Description

Complications and short-term results of two different transobturator techniques for surgical treatment of women with urinary incontinence: a randomized study



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Complications and short-term results of two different transobturator techniques for surgical treatment of women with urinary incontinence: a randomized study
Author But I, Faganelj M
Country --
Year 2008
Numbers Pubmed ID: 18188489
2397 (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 Transobturator synthetic Monarc outside-in
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2 Transobturator synthetic TVT-O inside-out
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country ... Other ... Slovenia
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Sling Category Obturator synthetic
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Multicenter? No
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Institution Type Unclear/Not reported
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No. of Surgeons Performing the Procedures 1
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Surgeons' Training Not reported
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Residents or Fellows Performing the Surgery? No
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Adverse Event Ascertainment Active
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Passive
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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
Transobturator synthetic Vaginal wall perforation Intra-op In-hospital ND ND 3 60 ND ND
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Transobturator synthetic Intra-op In-hospital ND ND 0 60
Total
Transobturator synthetic Vaginal wall mucosa tear "minor" tears Intra-op In-hospital ND ND 6 60 ND ND
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Transobturator synthetic Intra-op In-hospital ND ND 1 60
Total
Transobturator synthetic Bleeding "moderate hemorrhage" of 30-50mL blood Intra-op In-hospital ND ND 3 60 ND ND
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Transobturator synthetic Intra-op In-hospital ND ND 3 60
Total
Transobturator synthetic Pain, unspecified area (new or different after surgery) Required analgesic therapy within 6hr postop POD0 In-hospital No ND 15 60 ND 0.022
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Transobturator synthetic POD0 In-hospital No ND 27 60
Total
Transobturator synthetic Pain, unspecified area (new or different after surgery) Required analgesic therapy 6-24hr postop POD0 In-hospital No ND 30 60 ND 0.93
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Transobturator synthetic POD0 In-hospital No ND 37 60
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Transobturator synthetic Hematoma "extensive hematoma" region of thigh or labia majora <2 wk After discharge ND ND 0 60 ND ND
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Transobturator synthetic <2 wk After discharge ND ND 2 60
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Transobturator synthetic Infection, UTI <3mo After discharge ND ND 5 60 ND ND
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Transobturator synthetic <3mo After discharge ND ND 10 60
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Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue Vaginal erosion <3mo After discharge ND ND 0 60 ND NS
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Transobturator synthetic <3mo After discharge ND ND 0 60
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