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Study Title and Description

Tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: results of a multicentre randomised trial.



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 transobturator tape as surgery for stress urinary incontinence: results of a multicentre randomised trial.
Author Porena M, Costantini E, Frea B, Giannantoni A, Ranzoni S, Mearini L, Bini V, Kocjancic E.
Country --
Year 2007
Numbers Pubmed ID: 17482343
1853 (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 Transobturator (Ob-Tape)
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Italy
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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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Intrinsic sphincter deficiency
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Mixed incontinence
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RCT Comparison Category Retropubic vs. Obturator
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Multicenter Yes
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Institution Type Academic hospital
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Number of surgeons performing procedures ... Other ... not clear total number
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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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    This section has flags Flags (
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Overall Study Notes Interesting subanalysis provided for dry/improved/unchanged by vLPP </>60 and MUCP </>30 cm H2O
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Study Sponsor/Funding Industry
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Baseline Characteristics
Question TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 73 75
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Mean Age 61.8 60.6
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Post-Op Follow-Up Interval (Maximum) 32 mo (mean) 31 mo (mean)
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Results & Comparisons


Results Data
P-Value
Outcome: Transient voiding dysfunction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 N/A

Counts 3 2 NS
N Enrolled 73 75
P-Value
Outcome: "Dry"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


31 months

Counts 50 58 NS
N Analyzed 70 75
P-Value
Outcome: "Wet - improved"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


31 months

Counts 13 10 NS
N Analyzed 70 75
P-Value
Outcome: "Wet - failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


31 months

Counts 7 7 NS
N Analyzed 70 75
P-Value
Outcome: Pad counts per day      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 months

N Enrolled 73 75
Median 3 3
Max 8 10
Min 0 0


31 months

N Analyzed 70 75 NS
Median 0 0
Max 5 3
Min 0 0
Within-Arm Comparisons
Comparison Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic
0 months vs. 31 months N Analyzed 70 75
Median Difference -3 -3
P-Value <0.001 <0.001
P-Value P-Value
Outcome: UDI-6      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 months

Median 70 75 ND
Max 8 10
Min 19 21
N Analyzed 0 2


31 months

Median 0 0 NS
Max 21 21
Min 0 0
N Analyzed 70 75
P-Value P-Value
Outcome: IIQ-7      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 months

Median 8 8 ND
Max 16 18
Min 0 0
N Analyzed 70 75


31 months

Median 0 0 NS
Max 12 16
Min 0 0
N Analyzed 70 75
P-Value
Outcome: hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 N/A

Median 1.5 1.3 NS
Max 10 10
Min 1 1
N Enrolled 73 75
P-Value
Outcome: operative time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 N/A

Median 30 20 NS
Max 60 55
Min 20 20
N Enrolled 73 75


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
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2 Transobturator synthetic Obtape
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Italy
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Sling Category Retropubic synthetic
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Obturator synthetic
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training Urology
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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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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Study Sponsor/Funding Industry
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Results & Comparisons


Results Data
P-Value
Outcome: Transient voiding dysfunction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 N/A

Counts 3 2 NS
N Enrolled 73 75
P-Value
Outcome: "Dry"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


31 months

Counts 50 58 NS
N Analyzed 70 75
P-Value
Outcome: "Wet - improved"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


31 months

Counts 13 10 NS
N Analyzed 70 75
P-Value
Outcome: "Wet - failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


31 months

Counts 7 7 NS
N Analyzed 70 75
P-Value
Outcome: Pad counts per day      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 months

N Enrolled 73 75
Median 3 3
Max 8 10
Min 0 0


31 months

N Analyzed 70 75 NS
Median 0 0
Max 5 3
Min 0 0
Within-Arm Comparisons
Comparison Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic
0 months vs. 31 months N Analyzed 70 75
Median Difference -3 -3
P-Value <0.001 <0.001
P-Value P-Value
Outcome: UDI-6      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 months

Median 70 75 ND
Max 8 10
Min 19 21
N Analyzed 0 2


31 months

Median 0 0 NS
Max 21 21
Min 0 0
N Analyzed 70 75
P-Value P-Value
Outcome: IIQ-7      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 months

Median 8 8 ND
Max 16 18
Min 0 0
N Analyzed 70 75


31 months

Median 0 0 NS
Max 12 16
Min 0 0
N Analyzed 70 75
P-Value
Outcome: hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 N/A

Median 1.5 1.3 NS
Max 10 10
Min 1 1
N Enrolled 73 75
P-Value
Outcome: operative time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Transobturator (Ob-Tape) Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. Transobturator (Ob-Tape)


0 N/A

Median 30 20 NS
Max 60 55
Min 20 20
N Enrolled 73 75

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 Mesh erosion/extrusion/exposure/granulation tissue All 3 with Obtape required partial or complete removal 6mo-1yr postop 1 yr After discharge ND ND 0 73 ND ND
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Transobturator synthetic 1 yr After discharge ND ND 3 75 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bladder Intra-op In-hospital ND ND 2 73 ND NS
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Transobturator synthetic Intra-op In-hospital ND ND 1 75 ND
Total
Retropubic synthetic Vaginal perforation corrected by repeating manuever Intra-op In-hospital ND ND 0 73 ND NS
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Transobturator synthetic Intra-op In-hospital ND ND 4 75 ND
Total
Retropubic synthetic Bleeding Retropubic hematoma Peri-op In-hospital ND ND 1 73 ND ND
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Transobturator synthetic Peri-op In-hospital ND ND 0 75 ND
Total
Retropubic synthetic Return to OR Urethrolysis at 6mo 6 mo After discharge ND ND 1 73 ND ND
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Transobturator synthetic 6 mo After discharge ND ND 0 75 ND
Total