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Study Title and Description

Comparison of TVT and TVT-O in patients with stress urinary incontinence: short-term cure rates and factors influencing the outcome. A prospective randomised study.



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 TVT and TVT-O in patients with stress urinary incontinence: short-term cure rates and factors influencing the outcome. A prospective randomised study.
Author Karateke A., Haliloglu B., Cam C., Sakalli M.
Country Department of Obstetrics and Gynecology, Division of Urogynecology, Faculty of Medicine, Yeditepe University, Istanbul, Turkey.
Year 2009
Numbers Pubmed ID: 19281588
32 (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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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Turkey
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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.) Urodynamic SUI
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Intrinsic sphincter deficiency
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RCT Comparison Category Retropubic vs. Obturator
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Multicenter Unclear/Not reported
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Institution Type Academic hospital
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Number of surgeons performing procedures 1
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Surgeons' Training Urogynecology
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) A (good)
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Overall Study Notes Table6 of paper compares Cure, IIQ7, and UDI Q's 3-4 by subpopulations of vLPP</>60 and Qtip angle </>30. Comparisons are by vLPP and Qtip, not TVT-O vs TVT. Not sure how to capture these data since sub-population tables still want SlingA vs SlingB.
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Study Sponsor/Funding ... Other ... unclear
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Baseline Characteristics
Question TVT-O TVT Transobturator synthetic Retropubic synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 84 83
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Mean Age 49 49
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Post-Op Follow-Up Interval (Maximum) 14 mo
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Results & Comparisons


Results Data
P-Value
Outcome: EBL <200mL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Enrolled 83 81 0.207
Counts 82 77
Percentage 98.8 95.1
P-Value
Outcome: EBL >200      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Enrolled 83 81 0.207
Counts 1 4
Percentage 1.2 4.9
P-Value
Outcome: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.675
Counts 72 72
Percentage 86.7 88.9
P-Value
Outcome: Short-term catheterization      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Enrolled 83 81 0.544
Counts 6 8
Percentage 7.2 9.9
P-Value
Outcome: De novo DO      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.603
Counts 10 12
Percentage 12.0 14.8
P-Value
Outcome: De novo UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.723
Counts 5 6
Percentage 6.0 7.4
P-Value
Outcome: Very satisfied      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.826
Counts 69 68
Percentage 83.1 84.0
P-Value
Outcome: Satisfied      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.826
Counts 7 8
Percentage 8.4 9.9
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Analyzed 83 81 0.001
Mean 16.64 31.27
Standard Deviation 2.47 4.73
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Analyzed 83 81 0.290
Mean 1.25 1.36
Standard Deviation 0.66 0.76
P-Value
Outcome: Time 'til normal acitivities      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Analyzed 83 81 0.367
Mean 2.43 2.70
Standard Deviation 2.02 2.40
Outcome: PVR      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 10.96 11.05
Standard Deviation 5.60 5.90


12 months

N Analyzed 83 81
Mean 24.28 25.37
Standard Deviation 12.76 13.27
Outcome: IIQ-7      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 13.83 13.83
Standard Deviation 3.88 3.88


12 months

N Analyzed 83 81
Mean 6.88 6.94
Standard Deviation 3.38 3.40
Outcome: IIQ-7      Population: vLPP<60
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


12 months

N Analyzed
Mean
Standard Deviation
Outcome: UDI Q's1-2      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 1.00 1.04
Standard Deviation 0.81 0.83


12 months

N Analyzed 83 81
Mean 1.54 1.60
Standard Deviation 0.91 0.93
Outcome: UDI Q's3-4      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 4.24 4.22
Standard Deviation 1.36 1.36


12 months

N Analyzed 83 81
Mean 1.00 0.89
Standard Deviation 1.06 0.87
Outcome: UDI Q's5-6      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 0.75 0.75
Standard Deviation 0.87 0.83


12 months

N Analyzed 83 81
Mean 0.76 0.93
Standard Deviation 1.11 1.19


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Transobturator synthetic TVT-O
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2 Retropubic synthetic TVT
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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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Study Sponsor/Funding Not reported
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Results & Comparisons


Results Data
P-Value
Outcome: EBL <200mL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Enrolled 83 81 0.207
Counts 82 77
Percentage 98.8 95.1
P-Value
Outcome: EBL >200      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Enrolled 83 81 0.207
Counts 1 4
Percentage 1.2 4.9
P-Value
Outcome: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.675
Counts 72 72
Percentage 86.7 88.9
P-Value
Outcome: Short-term catheterization      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Enrolled 83 81 0.544
Counts 6 8
Percentage 7.2 9.9
P-Value
Outcome: De novo DO      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.603
Counts 10 12
Percentage 12.0 14.8
P-Value
Outcome: De novo UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.723
Counts 5 6
Percentage 6.0 7.4
P-Value
Outcome: Very satisfied      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.826
Counts 69 68
Percentage 83.1 84.0
P-Value
Outcome: Satisfied      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


12 months

N Enrolled 83 81 0.826
Counts 7 8
Percentage 8.4 9.9
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Analyzed 83 81 0.001
Mean 16.64 31.27
Standard Deviation 2.47 4.73
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Analyzed 83 81 0.290
Mean 1.25 1.36
Standard Deviation 0.66 0.76
P-Value
Outcome: Time 'til normal acitivities      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic Comparison Measure TVT-O vs. TVT


0 months

N Analyzed 83 81 0.367
Mean 2.43 2.70
Standard Deviation 2.02 2.40
Outcome: PVR      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 10.96 11.05
Standard Deviation 5.60 5.90


12 months

N Analyzed 83 81
Mean 24.28 25.37
Standard Deviation 12.76 13.27
Outcome: IIQ-7      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 13.83 13.83
Standard Deviation 3.88 3.88


12 months

N Analyzed 83 81
Mean 6.88 6.94
Standard Deviation 3.38 3.40
Outcome: IIQ-7      Population: vLPP<60
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


12 months

N Analyzed
Mean
Standard Deviation
Outcome: UDI Q's1-2      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 1.00 1.04
Standard Deviation 0.81 0.83


12 months

N Analyzed 83 81
Mean 1.54 1.60
Standard Deviation 0.91 0.93
Outcome: UDI Q's3-4      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 4.24 4.22
Standard Deviation 1.36 1.36


12 months

N Analyzed 83 81
Mean 1.00 0.89
Standard Deviation 1.06 0.87
Outcome: UDI Q's5-6      Population: All Participants
Time Point Measure TVT-O TVT Transobturator synthetic Retropubic synthetic


0 months

N Analyzed 83 81
Mean 0.75 0.75
Standard Deviation 0.87 0.83


12 months

N Analyzed 83 81
Mean 0.76 0.93
Standard Deviation 1.11 1.19

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
Transobturator synthetic Organ injury in OR (urethra, bladder, bowel) bladder; TVT-O did not actually have cysto Intra-op In-hospital ND ND 0 83 ND 0.118
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Retropubic synthetic Intra-op In-hospital ND ND 3 81 ND
Total
Transobturator synthetic Organ injury in OR (urethra, bladder, bowel) Vascular injury Intra-op In-hospital ND ND 0 83 ND NS
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Retropubic synthetic Intra-op In-hospital ND ND 0 81 ND
Total
Transobturator synthetic Hematoma Intra-op In-hospital ND ND 2 83 ND 0.440
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Retropubic synthetic Intra-op In-hospital ND ND 4 81 ND
Total
Transobturator synthetic Fever Unclear In-hospital ND ND 1 83 ND 0.364
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Retropubic synthetic Unclear In-hospital ND ND 4 81 ND
Total
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue 12mo After discharge ND ND 2 83 ND 0.440
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Retropubic synthetic 12mo After discharge ND ND 4 81 ND
Total