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Study Title and Description

Burch colposuspension and tension-free vaginal tape in the management of stress urinary incontinence in women.



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 Burch colposuspension and tension-free vaginal tape in the management of stress urinary incontinence in women.
Author Liapis A, Bakas P, Creatsas G.
Country --
Year 2002
Numbers Pubmed ID: 12074820
10 (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 epidural
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2 Burch epidural Burch performed via open technique with no 1 ethibond suture and all burch patients received a suprapubic catheter for 3-5 days as well as a drain in the space of retzius.
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Greece
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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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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 ... Other ... 2
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Surgeons' Training Not reported
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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 ... Other ... unknown
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Baseline Characteristics
Question TVT Burch Retropubic synthetic Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 36 35
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Mean Age 46.5y 48.4y
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Post-Op Follow-Up Interval (Maximum) 24mo 24mo
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Results & Comparisons


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


0 months

N Enrolled
Counts
Standard Deviation


24 months

N Enrolled 36 35 >.05
Counts 84% 86%
Standard Deviation
P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI objective improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


24 months

N Enrolled 36 35 >.05
Counts 6% 7%
Standard Deviation


0 months

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: post operation pain scale, 0-mild      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


24 months

N Enrolled
Counts
Standard Deviation


0 months

N Enrolled 36 35
Counts 100% 8%
Standard Deviation
<.001
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: post operation pain scale, rather/very      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


24 months

N Enrolled
Counts
Standard Deviation


0 months

N Enrolled 36 35
Counts 0 27%
Standard Deviation
<.001
Outcome: POD 1 analgesic use      Population: All Participants
Time Point Measure TVT Burch Retropubic synthetic Burch


24 months

N Enrolled
Counts
Standard Deviation


0 months

N Enrolled 36 35
Counts 0 27%
Standard Deviation
P-Value N Enrolled Mean Difference Standard Deviation
Outcome: operation time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 36 35 <.01
Mean 20min 58min
Standard Deviation


24 months

N Analyzed
Mean
Standard Deviation
P-Value P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


24 months

N Analyzed
Mean
Standard Deviation


0 months

N Analyzed 36 35 <.05
Mean 2.1d 5.7d
Standard Deviation
P-Value P-Value
Outcome: Time to return to normal activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 36 35 <.01
Mean 10d 21d
Standard Deviation


24 months

N Analyzed
Mean
Standard Deviation
P-Value P-Value
Outcome: max flow      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 36 35 >.05
Mean 29.29 28.42
Standard Deviation 8.88 8.21


24 months

N Analyzed 36 35 >.05
Mean 26.7 25.8
Standard Deviation 9.04 9.53


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT
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2 Burch Burch performed via open technique with no 1 ethibond suture and all burch patients received a suprapubic catheter for 3-5 days as well as a drain in the space of retzius
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Greece
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Sling Category Retropubic synthetic
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Multicenter? No
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures ... Other ... 2
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Surgeons' Training Not reported
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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 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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Results & Comparisons


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


0 months

N Enrolled
Counts
Standard Deviation


24 months

N Enrolled 36 35 >.05
Counts 84% 86%
Standard Deviation
P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI objective improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


24 months

N Enrolled 36 35 >.05
Counts 6% 7%
Standard Deviation


0 months

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: post operation pain scale, 0-mild      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


24 months

N Enrolled
Counts
Standard Deviation


0 months

N Enrolled 36 35
Counts 100% 8%
Standard Deviation
<.001
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: post operation pain scale, rather/very      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


24 months

N Enrolled
Counts
Standard Deviation


0 months

N Enrolled 36 35
Counts 0 27%
Standard Deviation
<.001
Outcome: POD 1 analgesic use      Population: All Participants
Time Point Measure TVT Burch Retropubic synthetic Burch


24 months

N Enrolled
Counts
Standard Deviation


0 months

N Enrolled 36 35
Counts 0 27%
Standard Deviation
P-Value N Enrolled Mean Difference Standard Deviation
Outcome: operation time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 36 35 <.01
Mean 20min 58min
Standard Deviation


24 months

N Analyzed
Mean
Standard Deviation
P-Value P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


24 months

N Analyzed
Mean
Standard Deviation


0 months

N Analyzed 36 35 <.05
Mean 2.1d 5.7d
Standard Deviation
P-Value P-Value
Outcome: Time to return to normal activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 36 35 <.01
Mean 10d 21d
Standard Deviation


24 months

N Analyzed
Mean
Standard Deviation
P-Value P-Value
Outcome: max flow      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 36 35 >.05
Mean 29.29 28.42
Standard Deviation 8.88 8.21


24 months

N Analyzed 36 35 >.05
Mean 26.7 25.8
Standard Deviation 9.04 9.53

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 Infection, UTI up to 6 mo 5 36
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Burch 2 35
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) bladder perforation up to 6 mo 4 36
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Burch 0 35
Total
Retropubic synthetic hematoma at incosion site up to 6 mo 36
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Burch 2 35
Total
Retropubic synthetic pain, incision site up to 6 mo 36
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Burch 4 35
Total
Retropubic synthetic urinary retention Urinary retention requiring suprapubic catheter for 14-21d up to 6 mo 36
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Burch 3 35
Total
Retropubic synthetic detrusor instability up to 6 mo 6 36
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Burch 5 35
Total
Retropubic synthetic sensory urgency up to 6 mo 2 36
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Burch 1 35
Total