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Study Title and Description

Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension-free vaginal tape for stress urinary 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 Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension-free vaginal tape for stress urinary incontinence.
Author Bai SW., Sohn WH., Chung DJ., Park JH., Kim SK.
Country Department of Obstetrics and Gynecology, Institute of Women's Life Science, Yonsei University, Yonsei University College of Medicine, Seoul, Korea. swbai@yumc.yonsei.ac.kr
Year 2005
Numbers Pubmed ID: 16242695
535 (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 Burch
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2 PVS, fascial autologous rectus muscle fascia
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3 TVT
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Design Details
Question... Follow Up Answer Follow-up Answer
Country South Korea
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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 ... Other comparison ... TVT vs Burch vs PVS
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Multicenter No
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Institution Type ... Other ... medical cente
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Number of surgeons performing procedures 1
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Surgeons' Training General
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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 ... Other ... unknown
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Baseline Characteristics
Question Burch PVS, fascial TVT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 33 28 31
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Mean Age 56.5yr 56.3yr 58.2
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Post-Op Follow-Up Interval (Maximum) 1yr 1yr 1yr
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial TVT Comparison Measure Burch vs. PVS, fascial


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 33 28 31
Counts 31 N 27 N 29 N
Standard Deviation
p<.05, favors PVS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: De novo DO      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial TVT Comparison Measure Burch vs. PVS, fascial


1 years

N Enrolled 33 28 31
Counts 3 0 0
Standard Deviation
not given


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Urinary retention      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial TVT Comparison Measure Burch vs. PVS, fascial


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 33 28 31
Counts 0 2 4
Standard Deviation
not given
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Urinary hesitancy      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial TVT Comparison Measure Burch vs. PVS, fascial


1 years

N Enrolled 33 28 31
Counts 1 0 0
Standard Deviation
not given


0 years

N Enrolled
Counts
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country South Korea
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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 Community hospital
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No. of Surgeons Performing the Procedures 1
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Surgeons' Training General
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Residents or Fellows Performing the Surgery? No
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Adverse Event Ascertainment Unclear/Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding ... Other ...
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Comments (overall study) No AEs reported
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial TVT Comparison Measure Burch vs. PVS, fascial


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 33 28 31
Counts 31 N 27 N 29 N
Standard Deviation
p<.05, favors PVS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: De novo DO      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial TVT Comparison Measure Burch vs. PVS, fascial


1 years

N Enrolled 33 28 31
Counts 3 0 0
Standard Deviation
not given


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Urinary retention      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial TVT Comparison Measure Burch vs. PVS, fascial


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 33 28 31
Counts 0 2 4
Standard Deviation
not given
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Urinary hesitancy      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial TVT Comparison Measure Burch vs. PVS, fascial


1 years

N Enrolled 33 28 31
Counts 1 0 0
Standard Deviation
not given


0 years

N Enrolled
Counts
Standard Deviation

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
Total None reported
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