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Study Title and Description

Comparison of tension-free vaginal taping versus modified Burch colposuspension on urethral obstruction: a randomized controlled trial.



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 tension-free vaginal taping versus modified Burch colposuspension on urethral obstruction: a randomized controlled trial.
Author Wang AC., Chen MC.
Country Division of Female Pelvic Medicine/Reconstructive Surgery, Department of Obstetrics/Gynecology, Chang Gung University, School of Medicine, Taoyuan, Taiwan. alexwang@cgmh.org.tw
Year 2003
Numbers Pubmed ID: 12707868
87 (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 Burch
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Taiwan
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Outcome Categories Reported Objective SUI
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Subjective SUI
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Population (reason for surgery etc.) Urodynamic SUI
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RCT Comparison Category Sling vs. Burch
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Multicenter No
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Institution Type Academic hospital
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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 ... Other ... unknown
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Baseline Characteristics
Question TVT Burch TVT Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 49 49 98
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Mean Age 50.65y (N=49) 52.8y (N=41)
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Post-Op Follow-Up Interval (Maximum) 22mo median 22mo median
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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 Objective-pad test cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


0 years

N Enrolled
Counts
Standard Deviation


22 months

N Enrolled 49 41
Counts 40 31
Standard Deviation
not given
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI Objective- pad test improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


22 months

N Enrolled 49 41
Counts 4 5
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: SUI Objective-pad test failure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


0 years

N Enrolled
Counts
Standard Deviation


22 months

N Enrolled 49 41
Counts 5 5
Standard Deviation
not given
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Genuine stress incontinence Objective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


22 months

N Enrolled 49 41
Counts 44 36
Standard Deviation
1.00


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


22 months

N Enrolled 49 41
Counts 45 38
Standard Deviation
1.00


0 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


0 years

N Analyzed 49 41
Mean 45 median 50 median
Standard Deviation


22 months

N Analyzed 49 41
Mean 20 median 20 median
Standard Deviation
.308


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 TVT
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2 Burch
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Design Details
Question... Follow Up Answer Follow-up Answer
Comments (overall study) Did not fill out as no AEs were given
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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 Objective-pad test cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


0 years

N Enrolled
Counts
Standard Deviation


22 months

N Enrolled 49 41
Counts 40 31
Standard Deviation
not given
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI Objective- pad test improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


22 months

N Enrolled 49 41
Counts 4 5
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: SUI Objective-pad test failure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


0 years

N Enrolled
Counts
Standard Deviation


22 months

N Enrolled 49 41
Counts 5 5
Standard Deviation
not given
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Genuine stress incontinence Objective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


22 months

N Enrolled 49 41
Counts 44 36
Standard Deviation
1.00


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


22 months

N Enrolled 49 41
Counts 45 38
Standard Deviation
1.00


0 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch TVT Burch Comparison Measure TVT vs. Burch


0 years

N Analyzed 49 41
Mean 45 median 50 median
Standard Deviation


22 months

N Analyzed 49 41
Mean 20 median 20 median
Standard Deviation
.308

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
TVT No AEs listed
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Burch
Total
TVT
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Burch
Total