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Study Title and Description

A randomised trial of a retropubic tension-free vaginal tape versus a mini-sling for stress incontinence.



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 A randomised trial of a retropubic tension-free vaginal tape versus a mini-sling for stress incontinence.
Author Basu M., Duckett J.
Country Department of Obstetrics and Gynaecology, Medway Maritime Hospital, Gillingham, Kent, UK. mayabasu@aol.com
Year 2010
Numbers Pubmed ID: 20175874
2711 (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 TVT
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2 Miniarc
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Design Details
Question... Follow Up Answer Follow-up Answer
Country UK
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Outcome Categories Reported Objective SUI
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Subjective SUI
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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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Minisling vs. Other
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Multicenter No
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Institution Type Unclear/Not reported
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Number of surgeons performing procedures Not reported
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Surgeons' Training Not reported
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) B (fair)
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Study Sponsor/Funding Industry
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Baseline Characteristics
Question TVT Miniarc Minisling obturator Retropubic synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 33 38
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Mean Age 48.2 49.7
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Post-Op Follow-Up Interval (Maximum) 6 mo 6 mo
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Results & Comparisons


Results Data
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Persistent SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Miniarc Minisling obturator Retropubic synthetic Comparison Measure TVT vs. Miniarc


6 months

N Analyzed 33 37 8.14
Counts 1 15 2.7
24.7
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Urodynamic stress incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Miniarc Minisling obturator Retropubic synthetic Comparison Measure TVT vs. Miniarc


6 months

N Analyzed 30 37 7.58
Counts 2 13 2.7
24.7


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling obturator
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2 Retropubic synthetic
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Sling Category Retropubic synthetic
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Minisling H (obturator)
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Adverse Event Ascertainment Passive
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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 Industry
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Results & Comparisons


Results Data
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Persistent SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Miniarc Minisling obturator Retropubic synthetic Comparison Measure TVT vs. Miniarc


6 months

N Analyzed 33 37 8.14
Counts 1 15 2.7
24.7
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Urodynamic stress incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Miniarc Minisling obturator Retropubic synthetic Comparison Measure TVT vs. Miniarc


6 months

N Analyzed 30 37 7.58
Counts 2 13 2.7
24.7

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
Minisling obturator Short term voiding dysfunction Catheter req'd >7d Unclear After dischrage ND ND 2 37 ND NS
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Retropubic synthetic 2 33
Total
Minisling obturator De novo DO <6mo After dischrage ND ND 2 37 ND NS
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Retropubic synthetic 2 33
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Minisling obturator Organ injury in OR (urethra, bladder, bowel) Urethra Intraop In-hospital ND ND 1 37 ND ND
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Retropubic synthetic 0 33
Total
Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue Vaginal <6mo After dischrage ND ND 2 37 ND ND
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Retropubic synthetic 0 33
Total
Minisling obturator Return to OR All for failure/ cont'd SUI Unclear After dischrage ND ND 9 37 ND <0.05
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Retropubic synthetic 0 33
Total