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Study Title and Description

The multifilament polypropylene tape erosion trouble: tape structure vs surgical technique. Which one is the cause?



Key Questions Addressed
1 Sling vs Comparator RCT outcomes (excluding AEs)
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2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title The multifilament polypropylene tape erosion trouble: tape structure vs surgical technique. Which one is the cause?
Author Sivaslioglu AA, Unlubilgin E, Dölen I
Country --
Year 2008
Numbers Pubmed ID: 17876489
2353 (internal)

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


Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 IVS Loose tensioning
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2 IVS Tape touching urethra, covered with fascia
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Turkey
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Outcome Categories Reported Objective SUI
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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Urodynamic SUI
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RCT Comparison Category Retropubic vs. Other
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Other comparison ... Retropubic sling (IVS tunneller vs itself with 2 tesnioning techniques)
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures 1
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Surgeons' Training Urogynecology
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Residents or fellows performing surgery? No
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Study Quality (overall) C (poor)
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Study Sponsor/Funding Industry
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Baseline Characteristics
Question IVS IVS IVS tunneler - LOOSE IVS tunneler - SNUG Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 50 57
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Mean Age 48 46
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Post-Op Follow-Up Interval (Maximum) 44 mo 44 mo
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Results & Comparisons


Results Data
P-Value
Outcome: Negative cough stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure IVS IVS IVS tunneler - LOOSE IVS tunneler - SNUG Comparison Measure IVS vs. IVS


44 months

N Analyzed 44 54 0.66
Percentage 87% 88%
P-Value
Outcome: De novo urgency UI      Population: All Participants Between-Arm Comparisons
Time Point Measure IVS IVS IVS tunneler - LOOSE IVS tunneler - SNUG Comparison Measure IVS vs. IVS


44 months

Counts 2 7 0.03
N Analyzed 44 54
Percentage 4.5% 12.9%


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 IVS tunneler - LOOSE
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2 IVS tunneler - SNUG
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country ... Other ... Turkey
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Sling Category Retropubic synthetic
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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


Results Data
P-Value
Outcome: Negative cough stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure IVS IVS IVS tunneler - LOOSE IVS tunneler - SNUG Comparison Measure IVS vs. IVS


44 months

N Analyzed 44 54 0.66
Percentage 87% 88%
P-Value
Outcome: De novo urgency UI      Population: All Participants Between-Arm Comparisons
Time Point Measure IVS IVS IVS tunneler - LOOSE IVS tunneler - SNUG Comparison Measure IVS vs. IVS


44 months

Counts 2 7 0.03
N Analyzed 44 54
Percentage 4.5% 12.9%

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
IVS tunneler - LOOSE Mesh erosion/extrusion/exposure/granulation tissue 44 mo After-discharge ND ND 6 44 ND 0.04
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IVS tunneler - SNUG 44 mo After-discharge ND ND 1 54 ND
Total
IVS tunneler - LOOSE De novo urgency 44 mo After-discharge ND ND 2 44 ND 0.03
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IVS tunneler - SNUG 44 mo After-discharge ND ND 7 54
Total
IVS tunneler - LOOSE Retention requiring surgery Vaginal urethrolysis Unclear After-discharge ND ND 0 44 ND 0.74
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IVS tunneler - SNUG 2 wk After-discharge ND ND 1 54 ND
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