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Study Title and Description

Comparison of three mid-urethral tension-free tapes (TVT, TVT-O, and TVT-Secur) in the treatment of female stress urinary incontinence: 1-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 Comparison of three mid-urethral tension-free tapes (TVT, TVT-O, and TVT-Secur) in the treatment of female stress urinary incontinence: 1-year follow-up.
Author Wang YJ., Li FP., Wang Q., Yang S., Cai XG., Chen YH.
Country Department of Urology, The Second Affiliated Hospital of Wenzhou Medical College, No. 109, Western Xueyuan Road, Wenzhou, Zhejiang, China, 325027.
Year 2011
Numbers Pubmed ID: 21567258
2945 (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
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3 TVT-Secur H AND U positions
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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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Subjective 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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Urodynamic SUI
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RCT Comparison Category Minisling vs. Other
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Multicenter Yes
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Institution Type Unclear/Not reported
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Number of surgeons performing procedures ... Other ... 2
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Surgeons' Training Urology
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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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Overall Study Notes Met power. Poor a priori definition or criteria for inclusion/exclusion. Overall, No mean f/u listed. Well organized randomization, but blinding of patient and outcome assessor not discussed- may cause bias. No author conflicts. No analysis of data by surgeon or site. needs better definition sui and inclusion/exclusion criteria. Shows decreased efficacy at 12 months for minisling
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Study Sponsor/Funding ... Other ... not clear
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Baseline Characteristics
Question TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 36 32 34 102
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Mean Age 56 57 57
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Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos 12 mos
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Results & Comparisons


Results Data
P-Value
Outcome: EBL >100cc      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 days

 N Enrolled 36 32 34 0314
Counts 1 2 0
Standard Deviation
P-Value
Outcome: Cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 years

 N Enrolled 36 32 34 0.005
Counts 33 30 23
Percentage 91.7 93.8 67.6
P-Value
Outcome: Improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 years

 N Enrolled 36 32 34 not given
Counts 3 2 7
Percentage 8.3 6.2 20.6
P-Value
Outcome: Failure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 years

 N Enrolled 36 32 34 0.016
Counts 0 0 4
Percentage 0 0 11.8
P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 years

 N Enrolled 0.095
Counts 6 5 12
Percentage 16.7 15.6 35.3
N Enrolled P-Value
Outcome: Surgical time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 days

 Counts
Standard Deviation 1.5 6.3 1.4 0.000
Mean 16.2 34.5 15.4
N Analyzed 36 32 34


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling retropubic BOTH H AND U positions
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2 Retropubic synthetic
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3 Transobturator synthetic
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Sling Category Retropubic synthetic
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Obturator synthetic
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Minisling H (obturator)
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Minsling U (retropubic)
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Multicenter? Yes
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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
P-Value
Outcome: EBL >100cc      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 days

 N Enrolled 36 32 34 0314
Counts 1 2 0
Standard Deviation
P-Value
Outcome: Cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 years

 N Enrolled 36 32 34 0.005
Counts 33 30 23
Percentage 91.7 93.8 67.6
P-Value
Outcome: Improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 years

 N Enrolled 36 32 34 not given
Counts 3 2 7
Percentage 8.3 6.2 20.6
P-Value
Outcome: Failure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 years

 N Enrolled 36 32 34 0.016
Counts 0 0 4
Percentage 0 0 11.8
P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 years

 N Enrolled 0.095
Counts 6 5 12
Percentage 16.7 15.6 35.3
N Enrolled P-Value
Outcome: Surgical time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT TVT-Secur H Minisling retropubic Retropubic synthetic Transobturator synthetic Comparison Measure All Arms (ANOVA)


1 days

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Standard Deviation 1.5 6.3 1.4 0.000
Mean 16.2 34.5 15.4
N Analyzed 36 32 34

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
Minisling retropubic Pain, groin (new or different after surgery) thigh pain; all resolved by 2 wk 1 yr after no undefined 0 34 0.008
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Retropubic synthetic 1 yr after no undefined 0 32 0.008
Transobturator synthetic 1 yr after no undefined 5 36 0.008
Total 5
Minisling retropubic Organ injury in OR (urethra, bladder, bowel) bladder 1 yr in hospital 1 34 0.576
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Retropubic synthetic 1 yr in hospital 1 32 0.576
Transobturator synthetic 1 yr in hospital 0 36 0.576
Total 2
Minisling retropubic Mild dysuria 1 wk short term no no mgmt or catheter placed 3 34 0.485
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Retropubic synthetic 1 wk short term no no mgmt or catheter placed 3 32 0.485
Transobturator synthetic 1 wk short term no no mgmt or catheter placed 1 36 0.485
Total
Minisling retropubic urine retention all resolved in 1 mo 1 mo after no spontaneous or catheter resolution 0 34 0.135
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Retropubic synthetic 1 mo after no spontaneous or catheter resolution 3 32 0.135
Transobturator synthetic 1 mo after no spontaneous or catheter resolution 1 36 0.135
Total