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Study Title and Description

A randomized trial comparing TVT with TVT-O: 12-month results.



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 A randomized trial comparing TVT with TVT-O: 12-month results.
Author Rinne K, Laurikainen E, Kivelä A, Aukee P, Takala T, Valpas A, Nilsson CG
Country --
Year 2008
Numbers Pubmed ID: 18373046
12 (internal)

Secondary Publication Information
UI Title Author Country Year
A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results. Palva K., Rinne K., Aukee P., Kivelä A., Laurikainen E., Takala T., Valpas A., Nilsson CG. Department of Obstetrics and Gynecology, Helsinki University Central Hospital, POB 140 Haartmaninkatu 2, 00029, Helsinki, Finland. 2010
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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 ... Finland
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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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Population (reason for surgery etc.) Symptomatic SUI
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Other ... positive cough stress test
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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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Community hospital
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Number of surgeons performing procedures ... Other ... 8
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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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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 136 132
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Mean Age 53 54
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Post-Op Follow-Up Interval (Maximum) 36 mo over 2 publications 36 mo over 2 publications
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Results & Comparisons


Results Data
P-Value P-Value
Outcome: Negative cough stress test      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 Analyzed 134 131 0.400
Percentage 95.5 93.1


36 months

N Analyzed 130 125 0.131
Percentage 94.6 89.5
P-Value P-Value
Outcome: Patient satisfaction      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 Analyzed 134 131 NS
Percentage 90 93


36 months

N Analyzed 130 125 NS
Percentage 90.0 91.2
P-Value P-Value
Outcome: Recommend to a friend      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 Analyzed 134 131 NS
Percentage 97 96


36 months

N Analyzed 131 125 NS
Percentage 98.4 95.2
Outcome: Urgency symptoms      Population: All Participants
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic


0 months

N Analyzed 134 131
Counts 27 23


12 months

N Analyzed 134 131
Counts 2 0
P-Value
Outcome: Rate of negative pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Analyzed 130 125 0.666
Percentage 92.7 94.1
P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Analyzed 130 125 0.27
Mean
Counts 12 7
Percentage 9.2 5.6
P-Value P-Value
Outcome: 24hr pad test      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 136 132
Median 41 42
Max 207 320
Min 0 0


12 months

N Analyzed 134 131 0.528
Median 0 0
Max 20 60
Min 0 0


36 months

N Analyzed 130 125 not given
Mean 3 3
Max 95 78
Min 0 0
P-Value P-Value
Outcome: Incontinence Severity (VAS)      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 134 131
Median 70 71
Max 100 100
Min 11 18


12 months

N Analyzed 134 131 NS
Median 1.5 0.5
Max 90 90
Min 0 0


36 months

N Analyzed 131 126 not diff, not given
Median 2 2
Max 91 87
Min 0 0
P-Value P-Value
Outcome: Urinary incontinence Severity Score (UISS)      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 134 131
Mean 11 11
Standard Deviation 3 3


12 months

N Analyzed 134 131 NS
Mean 0.7 0.4
Standard Deviation 1.8 1


36 months

N Analyzed 131 126 no diff, not given
Standard Deviation 1.2 0.9
Mean 2.3 1.8
P-Value P-Value
Outcome: Detrusor instability score (DIS)      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 134 131
Mean 5 4
Standard Deviation 2 2


12 months

N Analyzed 134 131 NS
Mean 2 2
Standard Deviation 2 2


36 months

N Analyzed 131 126 not given, not diff
Mean 3.0 2.7
Standard Deviation 2.6 2.5
P-Value P-Value
Outcome: IIQ-7      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 134 131
Mean 16 16
Standard Deviation 4 4


12 months

N Analyzed 134 131 NS
Mean 7 7
Standard Deviation 1 1


36 months

N Analyzed 131 126 not diff, not given
Mean 7.8 7.4
Standard Deviation 2.1 1.2
P-Value P-Value
Outcome: UDI-6      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 134 131
Mean 14 13
Standard Deviation 3 3


12 months

N Analyzed 134 131 NS
Mean 7 7
Standard Deviation 2 2


36 months

N Analyzed 131 126 not given, not diff
Mean 8.0 7.7
Standard Deviation 2.4 2.1
P-Value
Outcome: EuroQol-5D      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 134 131
Mean 0.855 0.876


12 months

N Analyzed 134 131 NS
Mean 0.901 0.933


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT Gynecare
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2 Transobturator synthetic TVT-O Gynecare
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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 P-Value
Outcome: Negative cough stress test      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 Analyzed 134 131 0.400
Percentage 95.5 93.1


36 months

N Analyzed 130 125 0.131
Percentage 94.6 89.5
P-Value P-Value
Outcome: Patient satisfaction      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 Analyzed 134 131 NS
Percentage 90 93


36 months

N Analyzed 130 125 NS
Percentage 90.0 91.2
P-Value P-Value
Outcome: Recommend to a friend      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 Analyzed 134 131 NS
Percentage 97 96


36 months

N Analyzed 131 125 NS
Percentage 98.4 95.2
Outcome: Urgency symptoms      Population: All Participants
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic


0 months

N Analyzed 134 131
Counts 27 23


12 months

N Analyzed 134 131
Counts 2 0
P-Value
Outcome: Rate of negative pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Analyzed 130 125 0.666
Percentage 92.7 94.1
P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


36 months

N Analyzed 130 125 0.27
Mean
Counts 12 7
Percentage 9.2 5.6
P-Value P-Value
Outcome: 24hr pad test      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 136 132
Median 41 42
Max 207 320
Min 0 0


12 months

N Analyzed 134 131 0.528
Median 0 0
Max 20 60
Min 0 0


36 months

N Analyzed 130 125 not given
Mean 3 3
Max 95 78
Min 0 0
P-Value P-Value
Outcome: Incontinence Severity (VAS)      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 134 131
Median 70 71
Max 100 100
Min 11 18


12 months

N Analyzed 134 131 NS
Median 1.5 0.5
Max 90 90
Min 0 0


36 months

N Analyzed 131 126 not diff, not given
Median 2 2
Max 91 87
Min 0 0
P-Value P-Value
Outcome: Urinary incontinence Severity Score (UISS)      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 134 131
Mean 11 11
Standard Deviation 3 3


12 months

N Analyzed 134 131 NS
Mean 0.7 0.4
Standard Deviation 1.8 1


36 months

N Analyzed 131 126 no diff, not given
Standard Deviation 1.2 0.9
Mean 2.3 1.8
P-Value P-Value
Outcome: Detrusor instability score (DIS)      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 134 131
Mean 5 4
Standard Deviation 2 2


12 months

N Analyzed 134 131 NS
Mean 2 2
Standard Deviation 2 2


36 months

N Analyzed 131 126 not given, not diff
Mean 3.0 2.7
Standard Deviation 2.6 2.5
P-Value P-Value
Outcome: IIQ-7      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 134 131
Mean 16 16
Standard Deviation 4 4


12 months

N Analyzed 134 131 NS
Mean 7 7
Standard Deviation 1 1


36 months

N Analyzed 131 126 not diff, not given
Mean 7.8 7.4
Standard Deviation 2.1 1.2
P-Value P-Value
Outcome: UDI-6      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 134 131
Mean 14 13
Standard Deviation 3 3


12 months

N Analyzed 134 131 NS
Mean 7 7
Standard Deviation 2 2


36 months

N Analyzed 131 126 not given, not diff
Mean 8.0 7.7
Standard Deviation 2.4 2.1
P-Value
Outcome: EuroQol-5D      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 134 131
Mean 0.855 0.876


12 months

N Analyzed 134 131 NS
Mean 0.901 0.933

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 Contact to health system 12mo After discharge ND ND 16.4% 134 ND 0.217
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Transobturator synthetic 12mo After discharge ND ND 22.9% 131 ND
Total
Retropubic synthetic Infection, UTI 12mo After discharge ND ND 19 134 ND NS
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Transobturator synthetic 12mo After discharge ND ND 22 131 ND
Total
Retropubic synthetic De novo urgency 12mo After discharge ND ND 2 134 ND NS
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Transobturator synthetic 12mo After discharge ND ND 3 131 ND
Total
Retropubic synthetic Retention symptoms Repeat catheterizations required b/t 2 and 12 mo 12mo After discharge ND ND 1 134 ND NS
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Transobturator synthetic 12mo After discharge ND ND 2 131 ND
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue 12mo After discharge ND ND 0 134 ND NS
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Transobturator synthetic 12mo After discharge ND ND 1 131 ND
Total
Retropubic synthetic Pain, other (new or different after surgery) lower abdomen (resolved by 8mo) 12mo After discharge ND ND 0 131 ND NS
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Transobturator synthetic 12mo After discharge ND ND 1 131 ND
Total
Retropubic synthetic Infection, UTI used antibiotics for a UTI (recurrent, pyelo, new UTI) 36 mo after discharge no 15.4% 131 not given
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Transobturator synthetic 36 mo after discharge no 17.6% 125
Total
Retropubic synthetic Return to OR TVT-O patient - erosion excised, sx returned, TVT done; in TVT pts, not satisfied so repeat TVT done 36 mo after discharge yes 2 131 not given
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Transobturator synthetic 36 mo after discharge yes 1 125
Total
Retropubic synthetic PVR median 36 mo after discharge no 5 131 0.032
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Transobturator synthetic 36 mo after discharge no 10 125 0.032
Total