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Study Title and Description

TVT-O vs TVT: a randomized trial in patients with different degrees of urinary stress 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 TVT-O vs TVT: a randomized trial in patients with different degrees of urinary stress incontinence.
Author Araco F, Gravante G, Sorge R, Overton J, De Vita D, Sesti F, Piccione E
Country --
Year 2008
Numbers Pubmed ID: 18217177
32066 (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 TVTO-SUI1 vLPP >90 cm H2O
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2 TVT-SUI1 vLPP >90cm H2O
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3 TVTO-SUI2 vLPP 60-90 cm H2O
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4 TVT-SUI2 vLPP 60-90 cm H2O
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Italy
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UK
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Outcome Categories Reported Objective 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 Retropubic vs. Obturator
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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 Not reported
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Residents or fellows performing surgery? No
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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 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 50 50 50 58
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Mean Age 53.2 53.6 54.0 54.5
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Post-Op Follow-Up Interval (Maximum) 12 mo 12 mo 12 mo 12 mo
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Results & Comparisons


Results Data
Statistical Test: P-Value Statistical Test: P-Value
Outcome: UDS "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure


0 months

N Enrolled 50 50 50 50
Counts 50 50 50 50
Percentage 100 100 100 100


12 months

N Enrolled 50 50 50 58
Counts 0 0 17 0
Percentage 0 0 34 0
Within-Arm Comparisons
Comparison Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2
0 months vs. 12 months P-Value <0.001 <0.001 <0.001 <0.001
Outcome: Detrusor overactivity      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


12 months

N Enrolled 50 50 50 58
Counts 2 2 1 0
Percentage 4 4 2 0
Outcome: Urodynamic Urgency      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


12 months

N Enrolled 50 50 50 58
Counts 3 4 3 4
Percentage 6 8 6 7
Statistical Test: P-Value
Outcome: Reoperation      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure TVTO-SUI2 vs. TVT-SUI2 TVTO-SUI1 AND TVTO-SUI2 vs. TVT-SUI1 AND TVT-SUI2


12 months

N Enrolled 50 50 50 58 McNemar and Fisher's Exact McNemar and Fisher's Exact
Counts 0 15 17 4 <0.001 <0.0001
Percentage 0 30 34 7
Outcome: Pad test      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


0 months

N Analyzed 50 50 50 58
Mean 57.7 56 59 67
Max 87 134 167 167
Min 15 15 36 36


6 months

N Analyzed 50 50 50 58
Mean 1 1 2 1
Max 56 56 120 56
Min 0 0 0 0
Outcome: i-QOL      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


0 months

N Analyzed 50 50 50 58
Mean 54 52 32 32
Standard Deviation 13.5 16.5 7.3 7.3


12 months

N Analyzed 50 50 50 58
Mean 104 96 73 104
Standard Deviation 6.3 5.7 31.0 5.8
N Enrolled P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure TVTO-SUI1 AND TVTO-SUI2 vs. TVT-SUI1 AND TVT-SUI2


0 months

N Analyzed 50 50 50 58 208
Mean 34 48 34 48 <0.001
Standard Deviation 11 9 12 6
N Enrolled P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure TVT-SUI1 vs. TVTO-SUI1


0 months

N Analyzed 50 50 50 58 208
Mean 2.4 5.4 3.2 3.5 <0.001
Standard Deviation 0.5 3.4 0.7 1.5
N Enrolled P-Value
Outcome: Postop pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure TVTO-SUI1 AND TVTO-SUI2 vs. TVT-SUI1 AND TVT-SUI2


24 hours

N Analyzed 50 50 50 58 208
Mean 2.6 7.3 2.6 6.7 <0.001
Standard Deviation 1.4 1.9 2.0 1.8
Outcome: Short-term retention      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


0 months

N Analyzed 50 50 50 58
Mean 1 2.3 1.8 1.7
Standard Deviation 0.2 2.0 1.0 1.6


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 TVTO-SUI1 vLPP >90 cm H2O
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2 TVT-SUI1 vLPP >90 cm H2O
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3 TVTO-SUI2 vLPP 60-90 cm H2O
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4 TVT-SUI2 vLPP 60-90 cm H2O
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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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Residents or Fellows Performing the Surgery? No
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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 Statistical Test: P-Value
Outcome: UDS "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure


0 months

N Enrolled 50 50 50 50
Counts 50 50 50 50
Percentage 100 100 100 100


12 months

N Enrolled 50 50 50 58
Counts 0 0 17 0
Percentage 0 0 34 0
Within-Arm Comparisons
Comparison Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2
0 months vs. 12 months P-Value <0.001 <0.001 <0.001 <0.001
Outcome: Detrusor overactivity      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


12 months

N Enrolled 50 50 50 58
Counts 2 2 1 0
Percentage 4 4 2 0
Outcome: Urodynamic Urgency      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


12 months

N Enrolled 50 50 50 58
Counts 3 4 3 4
Percentage 6 8 6 7
Statistical Test: P-Value
Outcome: Reoperation      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure TVTO-SUI2 vs. TVT-SUI2 TVTO-SUI1 AND TVTO-SUI2 vs. TVT-SUI1 AND TVT-SUI2


12 months

N Enrolled 50 50 50 58 McNemar and Fisher's Exact McNemar and Fisher's Exact
Counts 0 15 17 4 <0.001 <0.0001
Percentage 0 30 34 7
Outcome: Pad test      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


0 months

N Analyzed 50 50 50 58
Mean 57.7 56 59 67
Max 87 134 167 167
Min 15 15 36 36


6 months

N Analyzed 50 50 50 58
Mean 1 1 2 1
Max 56 56 120 56
Min 0 0 0 0
Outcome: i-QOL      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


0 months

N Analyzed 50 50 50 58
Mean 54 52 32 32
Standard Deviation 13.5 16.5 7.3 7.3


12 months

N Analyzed 50 50 50 58
Mean 104 96 73 104
Standard Deviation 6.3 5.7 31.0 5.8
N Enrolled P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure TVTO-SUI1 AND TVTO-SUI2 vs. TVT-SUI1 AND TVT-SUI2


0 months

N Analyzed 50 50 50 58 208
Mean 34 48 34 48 <0.001
Standard Deviation 11 9 12 6
N Enrolled P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure TVT-SUI1 vs. TVTO-SUI1


0 months

N Analyzed 50 50 50 58 208
Mean 2.4 5.4 3.2 3.5 <0.001
Standard Deviation 0.5 3.4 0.7 1.5
N Enrolled P-Value
Outcome: Postop pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 Comparison Measure TVTO-SUI1 AND TVTO-SUI2 vs. TVT-SUI1 AND TVT-SUI2


24 hours

N Analyzed 50 50 50 58 208
Mean 2.6 7.3 2.6 6.7 <0.001
Standard Deviation 1.4 1.9 2.0 1.8
Outcome: Short-term retention      Population: All Participants
Time Point Measure TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2 TVTO-SUI1 TVT-SUI1 TVTO-SUI2 TVT-SUI2


0 months

N Analyzed 50 50 50 58
Mean 1 2.3 1.8 1.7
Standard Deviation 0.2 2.0 1.0 1.6

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
TVTO-SUI1 Vaginal perforations Diff is b/t TVT-O and TVT, not SUI1 and SUI2 Intraop In-hospital ND ND 2 50 ND <0.05
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TVT-SUI1 Intraop In-hospital ND ND 0 50 ND
TVTO-SUI2 Intraop In-hospital ND ND 4 50 ND <0.05
TVT-SUI2 Intraop In-hospital ND ND 0 58 ND
Total
TVTO-SUI1 Organ injury in OR (urethra, bladder, bowel) Bladder perforation with nonsignif diff b/t TVT-O (1) and TVT (3) Intraop In-hospital ND ND 0 50 ND NS
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TVT-SUI1 Intraop In-hospital ND ND 1 50 ND
TVTO-SUI2 Intraop In-hospital ND ND 0 50 ND NS
TVT-SUI2 Intraop In-hospital ND ND 2 58 ND
Total
TVTO-SUI1 Hematoma Early hematomas; diff is b/t TVT-O and TVT, not SUI1 and SUI2 Periop In-hospital ND ND 0 50 ND <0.05
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TVT-SUI1 Periop In-hospital ND ND 3 50 ND
TVTO-SUI2 Periop In-hospital ND ND 0 50 ND <0.05
TVT-SUI2 Periop In-hospital ND ND 3 58 ND
Total
TVTO-SUI1 Obstruction requiring reoperation All in TVT-SUI1. Cath up to 3wk in 8pt and reop in 4pt 1mo After discharge ND ND 0 50 ND <0.001
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TVT-SUI1 1mo After discharge ND ND 12 50 ND
TVTO-SUI2 1mo After discharge ND ND 0 50 ND
TVT-SUI2 1mo After discharge ND ND 0 58 ND
Total
TVTO-SUI1 Mesh erosion/extrusion/exposure/granulation tissue Vaginal erosions 12mo After discharge ND ND 2 50 ND ND
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TVT-SUI1 12mo After discharge ND ND 0 50 ND
TVTO-SUI2 12mo After discharge ND ND 1 50 ND
TVT-SUI2 12mo After discharge ND ND 1 58 ND
Total
TVTO-SUI1 Return to OR All indications. No diff b/t SUI1 and SUI2 or TVTO vs TVT. But, diff within SUI1 (TVT>TVTO) and within SUI2 (TVTO>TVT) 12mo After discharge ND ND 0 50 ND <0.0001
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TVT-SUI1 12mo After discharge ND ND 15 50 ND
TVTO-SUI2 12mo After discharge ND ND 17 50 ND <0.0001
TVT-SUI2 12mo After discharge ND ND 14 58 ND
Total