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Study Title and Description

Untitled



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title
Author Tincello DG, Botha T, Grier D, Jones P, Subramaina D, Urquhart C, Kirkemo A, Khandwala S
Country University of Leicester and TVT worldwide registry
Year 2011
Numbers Pubmed ID: 22014817
831 (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 Minisling retropubic TVT secur
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3 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 Name The TVT Worldwide Observational Registry for Long-Term Data: Safety and Efficacy of Suburethral Sling Insertion Approaches for Stress Urinary Incontinence in Women
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Study Country US
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Austria
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Canada
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Germany
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South Korea
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UK
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Other ... Singapore, South Africa
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Sling Category Retropubic synthetic
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Obturator synthetic
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Minisling H (obturator)
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Minsling U (retropubic)
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Multicenter? Yes
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Institution Type Unclear/Not reported
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training Not reported
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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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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Comments (overall study) Study reporting of AEs were weak; they did track complications periop and post op; but did not list time point for post op complications (only listed patients were followed up for 1 year but had high attrition rate); also had a line in table for "other" that were not specifically defined in the text; strengths are that this was large numbers of patients undergoing TVT, TVT secur and TVT-O that were followed prospectively for outcomes/AEs; types of TVT Secur were not separated out for complications (ie, both H and U positions reported in aggregate)
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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 Mesh erosion/extrusion/exposure/granulation tissue listed as sling erosion up to 1 year post op after d/c not listed not listed 7 469 not listed 0.4998
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Minisling retropubic up to 1 year post op after d/c 8 677 not listed
Transobturator synthetic up to 1 year post op after d/c 1 252 not listed
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) bladder perforation in OR in hospital not listed not listed 10 469 not listed 0.0012
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Minisling retropubic in OR in hospital 1 677 not listed
Transobturator synthetic in OR in hospital 1 252 not listed
Total
Retropubic synthetic hematoma in OR in hospital not listed not listed 2 469 not listed 1.000
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Minisling retropubic in OR in hospital 4 677
Transobturator synthetic in OR in hospital 1 252
Total
Retropubic synthetic bleeding >200ml in OR in hospital not listed not listed 1 469 not listed 0.3347
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Minisling retropubic in OR in hospital 5 677 not listed
Transobturator synthetic in OR in hospital 0 252 not listed
Total
Retropubic synthetic Device injury not further defined - possibly lateral sulcus injury (extrapolating from text) in OR in hospital not listed not listed 0 469 not listed 0.0978
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Minisling retropubic 5 677 not listed
Transobturator synthetic 0 252 not listed
Total
Retropubic synthetic device malfunction not further defined in OR in hospital not listed not listed 0 469 not listed 1.000
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Minisling retropubic 1 677
Transobturator synthetic 0 252
Total
Retropubic synthetic Infection, UTI post op not listed not listed not listed 9 469 not listed 0.2098
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Minisling retropubic 5 677
Transobturator synthetic 2 252
Total
Retropubic synthetic urinary retention Did not specify if it lead to return to OR post op not listed not listed not listed 10 469 not listed 0.0082
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Minisling retropubic 2 677
Transobturator synthetic 2 252
Total
Retropubic synthetic de novo OAB criteria for this not given post op after discharge not listed not listed 14 469 not listed 0.0083
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Minisling retropubic 15 677
Transobturator synthetic 0 252
Total
Retropubic synthetic voiding dysfunction not further defined post op after discharge not listed not listed 10 469 not listed 0.0942
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Minisling retropubic 6 677
Transobturator synthetic 1 252
Total
Retropubic synthetic Pain, groin (new or different after surgery) not further defined post op after discharge not listed not listed 2 469 not listed 0.0041
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Minisling retropubic 0 677
Transobturator synthetic 4 252
Total
Retropubic synthetic Infection, surgical site/wound not further defined post op not listed not listed not listed 3 469 not listed 0.3338
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Minisling retropubic 1 677
Transobturator synthetic 1 252
Total
Retropubic synthetic mixed UI not further defined post op after discharge not listed not listed 1 469 not listed 0.7638
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Minisling retropubic 1 677
Transobturator synthetic 1 252
Total
Retropubic synthetic Pain, other (new or different after surgery) abdominal pain post op after discharge not listed not listed 0 469 not listed 0.6748
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Minisling retropubic 2 677
Transobturator synthetic 0 252
Total
Retropubic synthetic dyspareunia post op after discharge not listed not listed 0 469 not listed 0.1803
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Minisling retropubic 0 677
Transobturator synthetic 1 252
Total
Retropubic synthetic worsening urge incontinence not further defined post op after discharge not listed not listed 1 469 not listed 0.5157
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Minisling retropubic 0 677
Transobturator synthetic 0 252
Total
Retropubic synthetic other AEs not further defined post op after discharge not listed not listed 5 469 not listed 0.0831
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Minisling retropubic 1 677
Transobturator synthetic 1 252
Total