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Study Title and Description

Urodynamic changes after tension-free sling procedures: Mycromesh-PlusĀ® vs TVT sling



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Urodynamic changes after tension-free sling procedures: Mycromesh-PlusĀ® vs TVT sling
Author Cholhan HJ, Lotze PM.
Country University of Rochester NY
Year 2008
Numbers Pubmed ID: 17726566
1708 (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 Synthetic PVS modified polytetrafluoroethylene graft; Mycromesh-Plus
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Retrospective nonrandom (2+ slings analyzed separately)
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Study Name Urodynamic changes after tension free sling procedures
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Study Country US
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Sling Category Retropubic synthetic
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Pubovaginal (bladder neck)
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Multicenter? No
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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 Not reported
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment 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 Not reported
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Comments (overall study) AEs were reported but unclear follow up times and numbers analyzed; no statistical comparisons provided and short term follow up: 3 months documented but some patients reported as having retention up to 365 days
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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 retention requiring CISC up to 365 days in hospital and after discharge not listed not listed 4 60 not listed NS
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Synthetic PVS 9 58
Total
Retropubic synthetic Retention requiring surgery up to 365 days post op in hospital and after discharge not listed not listed 1 60 not listed not listed
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Synthetic PVS 3 58
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) intraop in hospital not listed not listed 1 60 not listed not listed
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Synthetic PVS 1 58
Total
Retropubic synthetic Transfusion post-op post op in hospital yes not listed 0 60 not listed not listed
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Synthetic PVS 3 58
Total
Retropubic synthetic hematoma retropubic post op in hospital not listed not listed 2 60 not listed not listed
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Synthetic PVS 3 58
Total
Retropubic synthetic Infection, surgical site/wound listed as "bacterial cellulitis of abdominal wound" and sterile abscess not listed not listed not listed not listed 1 60 not listed not listed
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Synthetic PVS "<5%" 58
Total
Retropubic synthetic Infection, UTI not listed not listed not listed not listed 6 60 not listed NS
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Synthetic PVS 10 58
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue not listed after discharge not listed not listed 0 60 not listed not listed
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Synthetic PVS 9 58
Total
Retropubic synthetic Return to OR for removal of exposed mesh not listed after discharge not listed not listed 0 60 not listed not listed
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Synthetic PVS 6 58
Total