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Study Title and Description

Tension-free vaginal tape versus tension-free vaginal tape obturator (inside-outside) in the surgical treatment of female 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 Tension-free vaginal tape versus tension-free vaginal tape obturator (inside-outside) in the surgical treatment of female stress urinary incontinence.
Author Aniuliene R.
Country Department of Obstetrics and Gynecology, Kaunas University of Medicine, Eiveniu 2, Kaunas 50009, Lithuania. rositaan@hotmail.com
Year 2009
Numbers Pubmed ID: 19773623
679 (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 ... Other ... Lithuania
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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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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) C (poor)
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Study Sponsor/Funding ... Other ... Unclear
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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 114 150
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Mean Age 51 49.9
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Post-Op Follow-Up Interval (Maximum) 12 mo 12 mo
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Results & Comparisons


Results Data
P-Value
Outcome: "Excellent"      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 114 150 NS
Counts 97 117
Percentage 85.1 78
P-Value
Outcome: "Good"      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 114 150 NS
Counts 11 25
Percentage 9.7 16.7
P-Value
Outcome: "Moderate"      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 114 150 NS
Counts 3 5
Percentage 2.6 3.3
P-Value
Outcome: "Bad"      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 114 150 NS
Counts 3 3
Percentage 2.6 2
P-Value
Outcome: Time in OR      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 114 150 <0.05
Mean 27 19
Standard Deviation 7.1 5.6
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. TVT-O


0 months

N Analyzed 114 150 <0.05
Mean 4.0 1.5
Standard Deviation 1.6 0.5
P-Value
Outcome: "Effectiveness"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

Mean 94.6 94.6 >0.05


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
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2 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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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: "Excellent"      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 114 150 NS
Counts 97 117
Percentage 85.1 78
P-Value
Outcome: "Good"      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 114 150 NS
Counts 11 25
Percentage 9.7 16.7
P-Value
Outcome: "Moderate"      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 114 150 NS
Counts 3 5
Percentage 2.6 3.3
P-Value
Outcome: "Bad"      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 114 150 NS
Counts 3 3
Percentage 2.6 2
P-Value
Outcome: Time in OR      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 114 150 <0.05
Mean 27 19
Standard Deviation 7.1 5.6
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. TVT-O


0 months

N Analyzed 114 150 <0.05
Mean 4.0 1.5
Standard Deviation 1.6 0.5
P-Value
Outcome: "Effectiveness"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

Mean 94.6 94.6 >0.05

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 Unclear After discharge ND ND 5 114 ND NS
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Transobturator synthetic Unclear After discharge ND ND 1 150 ND
Total
Retropubic synthetic Suprapubic hematoma Unclear Unclear ND ND 1 114 ND NS
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Transobturator synthetic Unclear Unclear ND ND 0 150 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bladder perforation Intraop In-hospital ND ND 1 114 ND ND
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Transobturator synthetic Intraop In-hospital ND ND 0 150 ND
Total
Retropubic synthetic Postop retention not defined Unclear Unclear ND ND 18 114 ND <0.05
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Transobturator synthetic Unclear Unclear ND ND 5 150 ND
Total
Retropubic synthetic "Irritated bladder" Unclear Unclear ND ND 6 114 ND NS
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Transobturator synthetic Unclear Unclear ND ND 5 150 ND
Total
Retropubic synthetic fever >38 Unclear Unclear ND ND 0 114 ND NS
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Transobturator synthetic Unclear Unclear ND ND 1 150 ND
Total