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Study Title and Description

Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month 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 Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up.
Author Oliveira R., Botelho F., Silva P., Resende A., Silva C., Dinis P., Cruz F.
Country Hospital de São João, Serviço de Urologia, Porto, Portugal.
Year 2011
Numbers Pubmed ID: 21277076

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 Miniarc
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Portugal
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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 Unclear/Not reported
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Number of surgeons performing procedures ... Other ... 5
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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) C (poor)
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Overall Study Notes Reached power. Randomization scheme vague. The study did not have adequate reporting of randomization scheme and blinding: this can bias results if surgeons performing study also did postoperative evaluations; also powered to find a success rate of >60% for each sling rather than comparing the slings to each other and small sample size. Used KHQ for QOL but only at 6mos so not extracted here. Not a single p value/CI was reported in the entire study.
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Study Sponsor/Funding ... Other ... reports funding as "none"
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Baseline Characteristics
Question TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 30 30 30 90
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Mean Age 52 53 53
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Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos 12 mos
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: SUI cure composite outcome      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 30 30 30 none reported
Counts 25 20 26 none reported
Percentage 83 67 87
Statistical Test: P-Value
Outcome: SUI improved composite outcome      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 30 30 30 none reported
Counts 3 4 2 none reported
Percentage 10 13 7
Statistical Test: P-Value
Outcome: SUI failure composite outcome      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 30 30 30 none reported
Counts 2 6 2 none reported
Percentage 7 20 7
Statistical Test: P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 30 30 30 none reported
Counts 5 3 3 none reported
Percentage
P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


24 hours

N Analyzed 30 30 30 none given!
Mean 4.5 2.3 1.0
Standard Deviation 2.6 2.3 1.0
Median 4 3 1
Max 10 6 3
Min 1 0 0


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 obturator minisling MiniArc
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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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Other ... another minisling obturator
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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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Comments (overall study) This study is poor (C).
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: SUI cure composite outcome      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 30 30 30 none reported
Counts 25 20 26 none reported
Percentage 83 67 87
Statistical Test: P-Value
Outcome: SUI improved composite outcome      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 30 30 30 none reported
Counts 3 4 2 none reported
Percentage 10 13 7
Statistical Test: P-Value
Outcome: SUI failure composite outcome      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 30 30 30 none reported
Counts 2 6 2 none reported
Percentage 7 20 7
Statistical Test: P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 30 30 30 none reported
Counts 5 3 3 none reported
Percentage
P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Miniarc Transobturator synthetic Minisling obturator obturator minisling MiniArc Comparison Measure All Arms (ANOVA)


24 hours

N Analyzed 30 30 30 none given!
Mean 4.5 2.3 1.0
Standard Deviation 2.6 2.3 1.0
Median 4 3 1
Max 10 6 3
Min 1 0 0

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 Retention requiring surgery 12 mos after 2 30 none reported
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Minisling obturator 12 mos after 0 30 none reported
obturator minisling MiniArc 12 mos after 0 30 none reported
Total
Transobturator synthetic Pain, groin (new or different after surgery) thigh "prolonged" 12 mos after 2 30 none reported
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Minisling obturator 12 mos after 0 30 none reported
obturator minisling MiniArc 12 mos after 1 30 none reported
Total
Transobturator synthetic Infection, UTI 12 mos after 0 30 none reported
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Minisling obturator 12 mos after 1 30 none reported
obturator minisling MiniArc 12 mos after 1 30 none reported
Total