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Study Title and Description

Complications of mid-urethral slings for treatment of stress urinary incontinence.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Complications of mid-urethral slings for treatment of stress urinary incontinence.
Author Pushkar DY., Godunov BN., Gvozdev M., Kasyan GR.
Country Moscow State University of Medicine and Dentistry, 127206, Vucheticha 21, Moscow, Russia.
Year 2011
Numbers Pubmed ID: 21315346
2217 (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 TVT
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2 Transobturator synthetic TVT-O
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Prospective nonrandom (2+ slings analyzed separately)
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Study Country ... Other ... Russia
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Sling Category Retropubic synthetic
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Obturator synthetic
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Multicenter? No
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures ... Other ... 5
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Surgeons' Training Urology
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Unclear/Not reported
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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 Not reported
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Comments (overall study) TVT versus TVT-O
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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 hematoma not defined 1 month not stated no no 17 187
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Transobturator synthetic 8 537
Total 25 724 0.001
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) bladder trauma 1 month not stated no no 10 187
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Transobturator synthetic 3 537
Total 13 724 0.001
Retropubic synthetic Pain, other (new or different after surgery) "postoperative pain" 1 month not stated no no 4 187
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Transobturator synthetic 11 537
Total 15 724 0.823
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) vaginal laceration 1 month not stated no no 0 187
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Transobturator synthetic 15 537
Total 15 724 0.044
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue tape extrusion 1 month after discharge no no 1 187
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Transobturator synthetic 8 537
Total 9 724 0.420
Retropubic synthetic de novo OAB 1 month after discharge no no 15 187
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Transobturator synthetic 26 537
Total 41 724 0.151
Retropubic synthetic de novo UUI 1 month after discharge no no 4 187
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Transobturator synthetic 8 537
Total 12 724 0.790
Retropubic synthetic Obstruction requiring reoperation sling incision 1 month after discharge no no 4 187
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Transobturator synthetic 3 537
Total 7 724 0.142
Retropubic synthetic PVR>100 1 month after discharge no no 11 187
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Transobturator synthetic 16 537
Total 27 724 0.114