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Study Title and Description

Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up.



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 Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up.
Author Masata J., Svabik K., Zvara K., Drahoradova P., El Haddad R., Hubka P., Martan A.
Country Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General Teaching Hospital, Prague, Czech Republic. masata@volny.cz
Year 2012
Numbers Pubmed ID: 22314891
8665 (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-O
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2 TVT-Secur H
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3 TVT-Secur U
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Czech Republic
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Outcome Categories Reported Objective SUI
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Subjective SUI
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Quality of life
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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Urodynamic SUI
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RCT Comparison Category Minisling vs. Other
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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) A (good)
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Overall Study Notes Three arm study. TVT S started to show poor outcomes but study still met power. Big loss to follow-up. Likely a single surgeon but not clear.
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Study Sponsor/Funding Government
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Baseline Characteristics
Question TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 68 64 65 197
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Mean Age 57 55 58 57
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Post-Op Follow-Up Interval (Maximum) 2.0 (mean) 1.9 (mean) 1.9 (mean) 2 years (median)
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: Objective cure SUI long-term      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher
Counts 63 44 45 <0.001
Percentage 92.6 68.8 69.2
Statistical Test: P-Value
Outcome: reoperation for sui      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher's
Counts 0 8 7 NA
Percentage 0 12.5 10.8
Statistical Test: P-Value
Outcome: Subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 not listed
Counts 61 46 51 0.03
Percentage 89.7 71.9 78.5
Statistical Test: P-Value
Outcome: subjective SUI - negative      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 not listed
Counts 58 44 40 0.01
Percentage 85.3 68.8 61.5
Statistical Test: P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Kruskall Wallis
Counts 13 8 5 NS
Percentage 19.1 12.5 7.7
Statistical Test: P-Value
Outcome: Failure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher
Counts 0 12 9 0.0002
Percentage 0 18.8 13.8
Statistical Test: P-Value Statistical Test: P-Value Statistical Test: P-Value
Outcome: objective cure - standing CST      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher
Counts 5 18 20 <0.001
Percentage 7.4 28.1 30.8


1 years

N Enrolled 66 62 64 Fisher
Counts 4 14 20 <0.001
Percentage 6.1 22.6 31.2


3 years

N Enrolled 68 64 65 Fisher
Counts 5 20 20 <0.001
Percentage 7.4 31.2 30.8
Statistical Test: P-Value Statistical Test: P-Value Statistical Test: P-Value
Outcome: Objective SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher
Counts 8 20 24 0.0017
Percentage 11.8 31.2 36.9


1 years

N Enrolled 66 62 64 Fisher
Counts 5 18 23 <0.001
Percentage 7.6 29.0 35.9


3 years

N Enrolled 68 64 65 Fisher
Counts 10 20 25 .01
Percentage 14.7 31.2 38.5
N Enrolled P-Value
Outcome: Length of procedure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 days

N Analyzed 68 64 65
Mean 8.3 10.8 11.4 <0.001
Standard Deviation 3.5 4.4 3.7
N Enrolled P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 days

N Analyzed 68 64 65
Mean 24.9 56.8 42.8 <0.001
Standard Deviation 16.2 129.1 22.2
N Enrolled P-Value
Outcome: subjective - ICIQ total score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 68 64 65
Mean 2.8 4.9 4.6 0.055
Standard Deviation 3.6 5.8 4.9
N Enrolled P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 68 64 65
Mean 99.1 91.1 94.6 ns
Standard Deviation 13.1 22.4 18.3
N Enrolled P-Value
Outcome: satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 68 64 65
Mean 94.4 80.4 85.4 ns
Standard Deviation 12.9 34.7 24.8


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Transobturator synthetic
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2 Minisling obturator
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3 Minisling retropubic
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Sling Category Obturator synthetic
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Minisling H (obturator)
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Minsling U (retropubic)
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Adverse Event Ascertainment Active
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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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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: Objective cure SUI long-term      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher
Counts 63 44 45 <0.001
Percentage 92.6 68.8 69.2
Statistical Test: P-Value
Outcome: reoperation for sui      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher's
Counts 0 8 7 NA
Percentage 0 12.5 10.8
Statistical Test: P-Value
Outcome: Subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 not listed
Counts 61 46 51 0.03
Percentage 89.7 71.9 78.5
Statistical Test: P-Value
Outcome: subjective SUI - negative      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 not listed
Counts 58 44 40 0.01
Percentage 85.3 68.8 61.5
Statistical Test: P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Kruskall Wallis
Counts 13 8 5 NS
Percentage 19.1 12.5 7.7
Statistical Test: P-Value
Outcome: Failure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher
Counts 0 12 9 0.0002
Percentage 0 18.8 13.8
Statistical Test: P-Value Statistical Test: P-Value Statistical Test: P-Value
Outcome: objective cure - standing CST      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher
Counts 5 18 20 <0.001
Percentage 7.4 28.1 30.8


1 years

N Enrolled 66 62 64 Fisher
Counts 4 14 20 <0.001
Percentage 6.1 22.6 31.2


3 years

N Enrolled 68 64 65 Fisher
Counts 5 20 20 <0.001
Percentage 7.4 31.2 30.8
Statistical Test: P-Value Statistical Test: P-Value Statistical Test: P-Value
Outcome: Objective SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Enrolled 68 64 65 Fisher
Counts 8 20 24 0.0017
Percentage 11.8 31.2 36.9


1 years

N Enrolled 66 62 64 Fisher
Counts 5 18 23 <0.001
Percentage 7.6 29.0 35.9


3 years

N Enrolled 68 64 65 Fisher
Counts 10 20 25 .01
Percentage 14.7 31.2 38.5
N Enrolled P-Value
Outcome: Length of procedure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 days

N Analyzed 68 64 65
Mean 8.3 10.8 11.4 <0.001
Standard Deviation 3.5 4.4 3.7
N Enrolled P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 days

N Analyzed 68 64 65
Mean 24.9 56.8 42.8 <0.001
Standard Deviation 16.2 129.1 22.2
N Enrolled P-Value
Outcome: subjective - ICIQ total score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 68 64 65
Mean 2.8 4.9 4.6 0.055
Standard Deviation 3.6 5.8 4.9
N Enrolled P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 68 64 65
Mean 99.1 91.1 94.6 ns
Standard Deviation 13.1 22.4 18.3
N Enrolled P-Value
Outcome: satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H TVT-Secur U Transobturator synthetic Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 68 64 65
Mean 94.4 80.4 85.4 ns
Standard Deviation 12.9 34.7 24.8

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
Transobturator synthetic Organ injury in OR (urethra, bladder, bowel) bladder + urethra + vagina 2 yrs in hospital no undefined 0 68 NA
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Minisling obturator 2 yrs in hospital no undefined 3 64 NA
Minisling retropubic 2 yrs in hospital no undefined 0 65 NA
Total
Transobturator synthetic Infection, UTI 2 yrs not clear no undefined 6 68 na
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Minisling obturator 2 yrs not clear no undefined 3 64 na
Minisling retropubic 2 yrs not clear no undefined 4 65 na
Total
Transobturator synthetic Return to OR "early tape release" not defined not clear yes undefined 2 68 NA
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Minisling obturator not defined not clear yes undefined 0 64 NA
Minisling retropubic not defined not clear yes undefined 1 65 NA
Total
Transobturator synthetic retention >24hr 1 wk in hospital no 2 68 NA
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Minisling obturator 1 wk in hospital no 0 64 NA
Minisling retropubic 1 wk in hospital no 1 65 NA
Total
Transobturator synthetic Retention requiring surgery "tape cut" 2 yrs after yes 2 68 NA
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Minisling obturator 2 yrs after yes 0 64 NA
Minisling retropubic 2 yrs after yes 0 65 NA
Total
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue 2 yrs after yes 1 68 NA
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Minisling obturator 2 yrs after yes 5 64 NA
Minisling retropubic 2 yrs after yes 4 65 NA
Total
Transobturator synthetic "chronic UTI" 2 yrs after no 2 68 NA
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Minisling obturator 2 yrs after no 0 64 NA
Minisling retropubic 2 yrs after no 1 65 NA
Total