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Study Title and Description

One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective 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 One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial.
Author Zullo MA., Plotti F., Calcagno M., Marullo E., Palaia I., Bellati F., Basile S., Muzii L., Angioli R., Panici PB.
Country Department of Obstetrics and Gynecology, University of Rome Campus Bio-medico, Via Longoni 83, 00155 Rome, Italy. m.zullo@unicampus.it
Year 2007
Numbers Pubmed ID: 17110021
14508 (internal)

Secondary Publication Information
UI Title Author Country Year
Tension-free vaginal tape versus transobturator suburethral tape: five-year follow-up results of a prospective, randomised trial. Angioli R., Plotti F., Muzii L., Montera R., Panici PB., Zullo MA. Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Rome, Italy. 2010
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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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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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Sexual function
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RCT Comparison Category Retropubic vs. Obturator
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Baseline Characteristics
Question TVT-O TVT Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 37 35 72
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Mean Age No data entered.
Post-Op Follow-Up Interval (Maximum) 60
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Results & Comparisons


Results Data
P-Value
Outcome: objective success SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 72.9 71.4 1
Counts 27 25
P-Value
Outcome: Late complication rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Mean 5 5 1
Standard Deviation
Percentage 16.1 17.2
P-Value P-Value
Outcome: Prolapse stage 0      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 26 20 1
Counts 8 6


0 months

Percentage 30 26 1
Counts 11 9
P-Value P-Value
Outcome: Prolapse stage 1      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 79 80 0.77
Counts 25 23


0 months

Percentage 65 71 0.77
Counts 24 25
P-Value
Outcome: Dyspareunia      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 1 1 1
Counts
P-Value
Outcome: Chronic pelvic pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 0.48
Counts 0 1
P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 1
Counts 2 1
P-Value P-Value P-Value P-Value P-Value
Outcome: urinary frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Percentage 0 0
Counts 0 0


12 months

Percentage 0 6 0.23
Counts 0 2


24 months

Percentage 0 0
Counts 0 0


48 months

Percentage 0 0
Counts 0 0


60 months

Percentage 0 0
Counts 0 0
P-Value P-Value P-Value P-Value P-Value
Outcome: urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Percentage 0 0
Counts 0 0


12 months

Percentage 0 9 0.11
Counts 0 3


24 months

Percentage 0 0
Counts 0 0


48 months

Percentage 3 3 1
Counts 1 1


60 months

Percentage 6 3 1
Counts 2 1
P-Value P-Value P-Value P-Value P-Value
Outcome: nocturia      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Percentage 0 3 0.49
Counts 0 1


12 months

Percentage 0 0
Counts 0 0


24 months

Percentage 0 0
Counts 0 0


48 months

Percentage 0 0
Counts 0 0


60 months

Percentage 0 0
Counts 0 0
P-Value P-Value P-Value P-Value P-Value
Outcome: detrusor overactivity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Percentage 0 0
Counts 0 0


12 months

Percentage 0 0
Counts 0 0


24 months

Percentage 0 0
Counts 0 0


48 months

Percentage 3 3 1
Counts 1 1


60 months

Percentage 3 3 1
Counts 1 1
P-Value
Outcome: Would undergo procedure again      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 78.4 62.8 0.0756
Counts 29 22
P-Value Statistical Test: P-Value Statistical Test:
Outcome: urethral hypermobility      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Mean 36.2 35.1 0.481
Standard Deviation 12.4 7.1


0 months

Mean 72.6 78.4 0.481
Standard Deviation 29.2 42.4
P-Value Statistical Test: P-Value Statistical Test:
Outcome: Urodynamics - peak flow      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Mean 26.6 25.8 0.23
Standard Deviation 5.5 6.3


60 months

Mean 22.7 21.8 0.23
Standard Deviation 3.4 3.3
P-Value Statistical Test: P-Value Statistical Test:
Outcome: Urodynamics - max cystometric capacity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


60 months

Mean 483 473 0.457
Standard Deviation 55 52


0 months

Mean 473 468 0.457
Standard Deviation 56 49
P-Value Statistical Test: P-Value Statistical Test:
Outcome: Urodynamics - Detrusor pressure at peak flow      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Mean 18.2 17.3 0.44
Standard Deviation 7.2 7.9


60 months

Mean 16.2 16.8 0.44
Standard Deviation 7.2 5.8
P-Value Statistical Test: P-Value Statistical Test:
Outcome: Urodynamics - MUCP      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Mean 61.2 57.6 0.06
Standard Deviation 9.2 8.3


0 months

Mean 59.4 55 0.06
Standard Deviation 8.2 8.5
Outcome: Satisfaction with procedure      Population: All Participants
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic


60 months

Mean
Standard Deviation


12 months

Mean
Standard Deviation


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 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
P-Value
Outcome: objective success SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 72.9 71.4 1
Counts 27 25
P-Value
Outcome: Late complication rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Mean 5 5 1
Standard Deviation
Percentage 16.1 17.2
P-Value P-Value
Outcome: Prolapse stage 0      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 26 20 1
Counts 8 6


0 months

Percentage 30 26 1
Counts 11 9
P-Value P-Value
Outcome: Prolapse stage 1      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 79 80 0.77
Counts 25 23


0 months

Percentage 65 71 0.77
Counts 24 25
P-Value
Outcome: Dyspareunia      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 1 1 1
Counts
P-Value
Outcome: Chronic pelvic pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 0.48
Counts 0 1
P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 1
Counts 2 1
P-Value P-Value P-Value P-Value P-Value
Outcome: urinary frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Percentage 0 0
Counts 0 0


12 months

Percentage 0 6 0.23
Counts 0 2


24 months

Percentage 0 0
Counts 0 0


48 months

Percentage 0 0
Counts 0 0


60 months

Percentage 0 0
Counts 0 0
P-Value P-Value P-Value P-Value P-Value
Outcome: urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Percentage 0 0
Counts 0 0


12 months

Percentage 0 9 0.11
Counts 0 3


24 months

Percentage 0 0
Counts 0 0


48 months

Percentage 3 3 1
Counts 1 1


60 months

Percentage 6 3 1
Counts 2 1
P-Value P-Value P-Value P-Value P-Value
Outcome: nocturia      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Percentage 0 3 0.49
Counts 0 1


12 months

Percentage 0 0
Counts 0 0


24 months

Percentage 0 0
Counts 0 0


48 months

Percentage 0 0
Counts 0 0


60 months

Percentage 0 0
Counts 0 0
P-Value P-Value P-Value P-Value P-Value
Outcome: detrusor overactivity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Percentage 0 0
Counts 0 0


12 months

Percentage 0 0
Counts 0 0


24 months

Percentage 0 0
Counts 0 0


48 months

Percentage 3 3 1
Counts 1 1


60 months

Percentage 3 3 1
Counts 1 1
P-Value
Outcome: Would undergo procedure again      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Percentage 78.4 62.8 0.0756
Counts 29 22
P-Value Statistical Test: P-Value Statistical Test:
Outcome: urethral hypermobility      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Mean 36.2 35.1 0.481
Standard Deviation 12.4 7.1


0 months

Mean 72.6 78.4 0.481
Standard Deviation 29.2 42.4
P-Value Statistical Test: P-Value Statistical Test:
Outcome: Urodynamics - peak flow      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Mean 26.6 25.8 0.23
Standard Deviation 5.5 6.3


60 months

Mean 22.7 21.8 0.23
Standard Deviation 3.4 3.3
P-Value Statistical Test: P-Value Statistical Test:
Outcome: Urodynamics - max cystometric capacity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


60 months

Mean 483 473 0.457
Standard Deviation 55 52


0 months

Mean 473 468 0.457
Standard Deviation 56 49
P-Value Statistical Test: P-Value Statistical Test:
Outcome: Urodynamics - Detrusor pressure at peak flow      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


0 months

Mean 18.2 17.3 0.44
Standard Deviation 7.2 7.9


60 months

Mean 16.2 16.8 0.44
Standard Deviation 7.2 5.8
P-Value Statistical Test: P-Value Statistical Test:
Outcome: Urodynamics - MUCP      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


60 months

Mean 61.2 57.6 0.06
Standard Deviation 9.2 8.3


0 months

Mean 59.4 55 0.06
Standard Deviation 8.2 8.5
Outcome: Satisfaction with procedure      Population: All Participants
Time Point Measure TVT-O TVT Retropubic synthetic Transobturator synthetic


60 months

Mean
Standard Deviation


12 months

Mean
Standard Deviation

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 60 mos after 1 35 1
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Transobturator synthetic 60 mos after 2 37 1
Total
Retropubic synthetic
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Transobturator synthetic
Total