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Study Title and Description

Randomized trial of tension-free vaginal tape and tension-free vaginal tape-obturator for urodynamic stress incontinence in women.



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 Randomized trial of tension-free vaginal tape and tension-free vaginal tape-obturator for urodynamic stress incontinence in women.
Author Teo R., Moran P., Mayne C., Tincello D.
Country Leicester Royal Infirmary, Worcester, United Kingdom. Rod.c.teo@uhl-tr.nhs.uk
Year 2011
Numbers Pubmed ID: 21334654
6713 (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 TVT-O
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Design Details
Question... Follow Up Answer Follow-up Answer
Country UK
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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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RCT Comparison Category Retropubic vs. Obturator
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Multicenter Yes
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Institution Type Unclear/Not reported
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Number of surgeons performing procedures Not reported
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Surgeons' Training Not reported
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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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Overall Study Notes Because this was essentially an interim analysis on a study which was halted early 2/2 concerns from other published papers (pain - felt unethical to recruit to TVT-O), I did not give the study an A. Did not reach power. Strong design, but incomplete study. High loss to follow-up. The study, however, is well randomized with specific outcomes that would have met power if the study was completed. Agree with grading
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Study Sponsor/Funding ... Other ... not clear
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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 66 61 127
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Mean Age 52 51
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Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos
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Results & Comparisons


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


1 years

N Enrolled 66 61 Chi square
Counts 33 25 0.31
Percentage 50 41
Statistical Test: P-Value
Outcome: SUI subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Enrolled 66 61 Chi square
Counts 35 26 0.24
Percentage 53 42.6
Statistical Test: P-Value
Outcome: de novo/worsening overactive bladder      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


1 years

N Enrolled 59 53 Fisher's
Counts 3 6 0.30
Percentage 5.1 11.3
Statistical Test: P-Value
Outcome: Symptom severity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Enrolled 37 27 chi square
Counts 13 15 0.10
Percentage 35.1 55.6
P-Value Statistical Test:
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 years

N Enrolled 66 61 0.02
Median 20 22 Mann Whitney U
Max 30 36
Min 15 17
P-Value Statistical Test:
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 years

N Enrolled 66 61 0.97
Median 50 50 Mann Whitney U
Max 200 400
Min 20 20
P-Value Statistical Test:
Outcome: Return to normal activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 59 48 0.58
Median 14 14 Mann Whitney
Max 90 60
Min 1 0
P-Value Statistical Test:
Outcome: Days to discharge      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 66 61 Mann Whitney U
Median 0 0 0.9
Max 1 1
Min 0 0
P-Value Statistical Test:
Outcome: Disease-specific QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Analyzed 37 27 0.82
Median 50 61 Mann Whitney U
Max 510 748
Min 0 0
P-Value Statistical Test:
Outcome: Symptom severity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


1 years

N Analyzed 37 27 0.19
Median 4 0 Mann Whitney U
Max 16 11
Min 0 0
P-Value Statistical Test:
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Analyzed 41 29 0.91
Median 1.8 0 Mann Whitney U
Max 90.8 142
Min 0 0
P-Value Statistical Test:
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Analyzed 36 26 0.23
Median 0 0 Mann Whitney U
Max 6 9
Min 0 0


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? Yes
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Comments (overall study) Investigators met regularly to review data. When 2 studies came out that showed high incidence of thigh pain with obturator slings, study was stopped early.
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Results & Comparisons


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


1 years

N Enrolled 66 61 Chi square
Counts 33 25 0.31
Percentage 50 41
Statistical Test: P-Value
Outcome: SUI subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Enrolled 66 61 Chi square
Counts 35 26 0.24
Percentage 53 42.6
Statistical Test: P-Value
Outcome: de novo/worsening overactive bladder      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


1 years

N Enrolled 59 53 Fisher's
Counts 3 6 0.30
Percentage 5.1 11.3
Statistical Test: P-Value
Outcome: Symptom severity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Enrolled 37 27 chi square
Counts 13 15 0.10
Percentage 35.1 55.6
P-Value Statistical Test:
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 years

N Enrolled 66 61 0.02
Median 20 22 Mann Whitney U
Max 30 36
Min 15 17
P-Value Statistical Test:
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 years

N Enrolled 66 61 0.97
Median 50 50 Mann Whitney U
Max 200 400
Min 20 20
P-Value Statistical Test:
Outcome: Return to normal activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 59 48 0.58
Median 14 14 Mann Whitney
Max 90 60
Min 1 0
P-Value Statistical Test:
Outcome: Days to discharge      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 66 61 Mann Whitney U
Median 0 0 0.9
Max 1 1
Min 0 0
P-Value Statistical Test:
Outcome: Disease-specific QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Analyzed 37 27 0.82
Median 50 61 Mann Whitney U
Max 510 748
Min 0 0
P-Value Statistical Test:
Outcome: Symptom severity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


1 years

N Analyzed 37 27 0.19
Median 4 0 Mann Whitney U
Max 16 11
Min 0 0
P-Value Statistical Test:
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Analyzed 41 29 0.91
Median 1.8 0 Mann Whitney U
Max 90.8 142
Min 0 0
P-Value Statistical Test:
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

N Analyzed 36 26 0.23
Median 0 0 Mann Whitney U
Max 6 9
Min 0 0

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 hemorrhage undefined volume 12 mos in hospital unclear undefined 1 66 0.95
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Transobturator synthetic 12 mos in hospital unclear undefined 1 61 0.95
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bladder perforation 12 mos in hospital unclear undefined 0 66 n/a
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Transobturator synthetic 12 mos in hospitsl unclear undefined 0 61
Total
Retropubic synthetic vaginal perforation 12 mos in hospital unclear undefined 0 66 0.12
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Transobturator synthetic 12 mos in hospital unclear undefined 3 61 0.12
Total
Retropubic synthetic Pain, groin (new or different after surgery) Leg 12 mos after unclear undefined 1 59 0.00001
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Transobturator synthetic 12 mos after unclear undefined 14 23 0.00001
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue 12 mos after unclear undefined 3 57 CI 12.1-37.4 0.43
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Transobturator synthetic 12 mos after unclear undefined 1 50 CI 12.1-37.4 0.43
Total
Retropubic synthetic Pain, other (new or different after surgery) 1st 2hrs - median VAS score 2 hrs in hospital unclear undefined 1 65 0.005
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Transobturator synthetic 2 hrs in hospital unclear undefined 2 61 0.005
Total
Retropubic synthetic
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Transobturator synthetic
Total