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Study Title and Description

Transobturator tape procedure versus tension-free vaginal tape for treatment of 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 Transobturator tape procedure versus tension-free vaginal tape for treatment of stress urinary incontinence.
Author Wang W., Zhu L., Lang J.
Country Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China.
Year 2009
Numbers Pubmed ID: 18957269
20 (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 TVT-O
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Design Details
Question... Follow Up Answer Follow-up Answer
Country China
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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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Recurrent incontinence after surgery
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Concomitant prolapse surgery
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RCT Comparison Category Retropubic vs. Obturator
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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 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 TVT-O Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 160 155
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Mean Age 55.0 54.8
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Post-Op Follow-Up Interval (Maximum) 19.6 mo 20.5 mo
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Results & Comparisons


Results Data
P-Value
Outcome: PVR <100mL at 12h      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Enrolled 154 146 0.50
Counts 130 119
Percentage 84.4 81.5
P-Value
Outcome: 12mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Enrolled 115 118 0.95
Counts 103 106
Percentage 89.6 89.8
P-Value
Outcome: 12mo "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Enrolled 115 118 0.77
Counts 10 9
Percentage 8.7 7.6
P-Value
Outcome: 12mo "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Enrolled 115 118 1.00
Counts 2 3
Percentage 1.7 2.5
P-Value
Outcome: 24mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


24 months

N Enrolled 78 87 0.85
Counts 68 75
Percentage 87.2 86.2
P-Value
Outcome: 24mo "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


24 months

N Enrolled 78 87 0.80
Counts 8 10
Percentage 10.3 11.5
P-Value
Outcome: 24mo "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


24 months

N Enrolled 78 87 1.00
Counts 2 2
Percentage 2.6 2.3
P-Value
Outcome: 36mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Enrolled 35 30 0.96
Counts 29 25
Percentage 82.9 83.3
P-Value
Outcome: 36mo "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Enrolled 35 30 1.00
Counts 5 4
Percentage 14.3 13.3
P-Value
Outcome: 36mo "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Enrolled 35 30 0.91
Counts 1 1
Percentage 2.9 3.3
P-Value
Outcome: Time in OR--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 154 146 <0.001
Mean 25.1 18.4
Standard Deviation 4.8 4.0
P-Value
Outcome: EBL--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 154 146 0.18
Mean 22.5 20.7
Standard Deviation 12.5 11.8
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. ERROR


0 months

N Analyzed 154 146 0.40
Mean 3.6 3.9
Standard Deviation 2.9 2.8


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT
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2 Transobturator synthetic TVT-O
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Design Details
Question... Follow Up Answer Follow-up Answer




Results & Comparisons


Results Data
P-Value
Outcome: PVR <100mL at 12h      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Enrolled 154 146 0.50
Counts 130 119
Percentage 84.4 81.5
P-Value
Outcome: 12mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Enrolled 115 118 0.95
Counts 103 106
Percentage 89.6 89.8
P-Value
Outcome: 12mo "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Enrolled 115 118 0.77
Counts 10 9
Percentage 8.7 7.6
P-Value
Outcome: 12mo "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Enrolled 115 118 1.00
Counts 2 3
Percentage 1.7 2.5
P-Value
Outcome: 24mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


24 months

N Enrolled 78 87 0.85
Counts 68 75
Percentage 87.2 86.2
P-Value
Outcome: 24mo "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


24 months

N Enrolled 78 87 0.80
Counts 8 10
Percentage 10.3 11.5
P-Value
Outcome: 24mo "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


24 months

N Enrolled 78 87 1.00
Counts 2 2
Percentage 2.6 2.3
P-Value
Outcome: 36mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Enrolled 35 30 0.96
Counts 29 25
Percentage 82.9 83.3
P-Value
Outcome: 36mo "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Enrolled 35 30 1.00
Counts 5 4
Percentage 14.3 13.3
P-Value
Outcome: 36mo "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Enrolled 35 30 0.91
Counts 1 1
Percentage 2.9 3.3
P-Value
Outcome: Time in OR--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 154 146 <0.001
Mean 25.1 18.4
Standard Deviation 4.8 4.0
P-Value
Outcome: EBL--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 154 146 0.18
Mean 22.5 20.7
Standard Deviation 12.5 11.8
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. ERROR


0 months

N Analyzed 154 146 0.40
Mean 3.6 3.9
Standard Deviation 2.9 2.8

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 Hematoma <3mo After discharge No ND 2 154 ND 1.00
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Transobturator synthetic <3mo After discharge No ND 2 146 ND
Total
Retropubic synthetic Infection, surgical site/wound Unclear After discharge ND ND 0 154 ND ND
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Transobturator synthetic Unclear After discharge ND ND 0 146 ND
Total
Retropubic synthetic Urinary retention Needed intervention not defined >12mo After discharge ND ND 6 154 ND 0.81
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Transobturator synthetic >12mo After discharge ND ND 4 146 ND
Total
Retropubic synthetic De novo urinary urgency Needed intervention not defined >12mo After discharge ND ND 9 154 ND 0.49
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Transobturator synthetic >12mo After discharge ND ND 6 146 ND
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue Vaginal >12mo After discharge ND ND 3 154 ND 1.00
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Transobturator synthetic >12mo After discharge ND ND 3 146 ND
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue Bladder >12mo After discharge ND ND 0 154 ND 1.00
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Transobturator synthetic >12mo After discharge ND ND 0 146 ND
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue Urethral >12mo After discharge ND ND 0 154 ND 1.00
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Transobturator synthetic >12mo After discharge ND ND 0 146 ND
Total
Retropubic synthetic Pain, groin (new or different after surgery) >12mo After discharge ND ND 4 154 ND 0.03
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Transobturator synthetic >12mo After discharge ND ND 12 146 ND
Total