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Study Title and Description

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures.



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-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures.
Author Hota LS., Hanaway K., Hacker MR., Disciullo A., Elkadry E., Dramitinos P., Shapiro A., Ferzandi T., Rosenblatt PL.
Country Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, MA, USA. lhota@mah.harvard.edu
Year -- Not Found --
Numbers Pubmed ID: 22453267
2622 (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-Secur H
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2 TVT-O
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Design Details
Question... Follow Up Answer Follow-up Answer
Trial Name none
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Country US
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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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Urodynamic SUI
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RCT Comparison Category Minisling vs. Other
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures Not reported
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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 terminated early after interim analysis - not planned but concerns raised by investigators for failure of TVT Secur (unblinded study) Did you downgrade an outcome – and why? Yes – did not perform ITT analysis appropriately Concerns about subject dropout in general? In one group specifically? 3 women in each group with no f/u. 1 in TVTs and 2 in TVTo without CST, but questionnaires completed. 1 woman randomized to TVT-S but did not meet inclusion criteria. Overall 10/77 (13%) randomized women with missing data. Were appropriate outcomes assessed? What differences (or lack thereof) stand out between groups? Unfortunate that item specific questions of PFDI-20 were not evaluated (ie- stress and urge specific questions; subjective leakage) Were all AEs assessed for? Were there significant concerns between groups about AEs? Paper did not state if other AEs occurred. Dindo classification used? No Was there a data safety monitoring board? No
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Study Sponsor/Funding Industry
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Academia
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Baseline Characteristics
Question TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 42 44 86
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Mean Age 52 51
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Post-Op Follow-Up Interval (Maximum) 8.2 mos (mean) 8.6 mos (mean)
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Results & Comparisons


Results Data
P-Value
Outcome: reoperation for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 years

N Enrolled 42 44 0.002
Counts 8 0
Standard Deviation 19.1 0
P-Value
Outcome: Choose a suggested Outcome...      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 years

N Enrolled 20 23 0.04
Counts 11 20
Percentage 55 87
P-Value
Outcome: Time in OR--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Analyzed 42 44 <0.0001
Median 10.0 13.0
25th Percentile 8.0 12.0
75th Percentile 12.0 17.0
P-Value P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Enrolled 42 44 0.20
Median 3 3
25th Percentile 1 1
75th Percentile 3.5 5


7 days

N Enrolled 42 44 0.046
Median 0 1
25th Percentile 0 0
75th Percentile 1 3
P-Value
Outcome: Length of catheterization      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 weeks

N Enrolled 42 44 0.46
Median 0 0
25th Percentile 0 0
75th Percentile 1 1
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Analyzed 42 44 0.06
Median 20 20
25th Percentile 20 10
75th Percentile 30 30
P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 years

N Analyzed 16 20 0.94
Median 37 48.4
25th Percentile 21.5 28.7
75th Percentile 73.4 60.4
P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 years

N Analyzed 17 20 0.48
Median 33.3 23.8
25th Percentile 7.6 14.3
75th Percentile 42.9 42.8


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling obturator
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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 Obturator synthetic
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Minisling H (obturator)
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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: reoperation for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 years

N Enrolled 42 44 0.002
Counts 8 0
Standard Deviation 19.1 0
P-Value
Outcome: Choose a suggested Outcome...      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 years

N Enrolled 20 23 0.04
Counts 11 20
Percentage 55 87
P-Value
Outcome: Time in OR--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Analyzed 42 44 <0.0001
Median 10.0 13.0
25th Percentile 8.0 12.0
75th Percentile 12.0 17.0
P-Value P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Enrolled 42 44 0.20
Median 3 3
25th Percentile 1 1
75th Percentile 3.5 5


7 days

N Enrolled 42 44 0.046
Median 0 1
25th Percentile 0 0
75th Percentile 1 3
P-Value
Outcome: Length of catheterization      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 weeks

N Enrolled 42 44 0.46
Median 0 0
25th Percentile 0 0
75th Percentile 1 1
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Analyzed 42 44 0.06
Median 20 20
25th Percentile 20 10
75th Percentile 30 30
P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 years

N Analyzed 16 20 0.94
Median 37 48.4
25th Percentile 21.5 28.7
75th Percentile 73.4 60.4
P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 years

N Analyzed 17 20 0.48
Median 33.3 23.8
25th Percentile 7.6 14.3
75th Percentile 42.9 42.8

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
Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue 1 yr after undefined 8 42 0.002
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Transobturator synthetic 1 yr after undefined 0 44 0.002
Total 1 yr
Minisling obturator Obstruction requiring reoperation 1 yr after undefined 1 42 0.49
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Transobturator synthetic 1 yr after undefined 0 44 0.49
Total