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Study Title and Description

Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.



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 Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.
Author Deffieux X., Daher N., Mansoor A., Debodinance P., Muhlstein J., Fernandez H.
Country Univ Paris-Sud, Le Kremlin Bicêtre, France. xavier.deffieux@abc.aphp.fr
Year 2010
Numbers Pubmed ID: 20552165
2670 (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 France
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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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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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Mixed incontinence
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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 ... 14 centers - number of surgeons not clear
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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) A (good)
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Overall Study Notes Did not reach power.
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Study Sponsor/Funding ... Other ... not listed
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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 75 74 149
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Mean Age 55 53
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Post-Op Follow-Up Interval (Maximum) 24 mos 24 mos
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Results & Comparisons


Results Data
P-Value
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


1 days

 Counts 20.3 18.7 0.26
P-Value
Outcome: catheterization at greater than 48hrs      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 weeks

 Counts 6 2 0.27
N Analyzed 75 74
P-Value P-Value
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


1 years

 Counts 65 67 0.68
N Analyzed 69 69
Percentage 94 97


2 years

 Counts 61 65 0.43
N Analyzed 65 67
Percentage 94 97
P-Value P-Value
Outcome: Overall cure rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 Counts 62 61 1
N Analyzed 69 69
Percentage 89 88


1 years

 Counts 54 56 1
N Analyzed 65 67
Percentage 83 83
P-Value P-Value
Outcome: Subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


1 years

 Counts 63 61 0.77
N Analyzed 69 69
Percentage 91 88


2 years

 Counts 55 56 1
N Analyzed 65 67
Percentage 84 83
P-Value P-Value
Outcome: "other" subjective cure rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 Counts 54 57 0.81
N Analyzed 65 67
Percentage 83 85


1 years

 Counts 57 58 1
N Analyzed 69 69
Percentage 82 84
P-Value
Outcome: Recurrence of incontinence in ISD patients in group      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 Counts 3 4 1
N Analyzed 8 10
Percentage 37 40
P-Value
Outcome: incontinence with intercourse      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 N Analyzed 44 52 1
Counts 0 1
Percentage 0 3
P-Value
Outcome: Peak flow      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

 range 15-24 15-27.75 0.15
median 20 21.50
P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

 range 0-50 0-10.25 0.03
median 10 0
P-Value
Outcome: First voiding desire      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

 range 160-243 151-247 0.70
median 200 201
P-Value
Outcome: MUCP      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

 range 38-65 3-60 0.94
median 50 50
P-Value
Outcome: Sexual activity satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


2 years

 range 70-100 70-100 not given
median 90 85
P-Value
Outcome: Satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 range 0.66
median 87.7 86.1
P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


2 years

 range no data no data no difference, no p value given
median
P-Value
Outcome: Discomfort associated with bladder outlet obstruction symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 range 0-20 0-20 0.66
median 10 5


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 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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Results & Comparisons


Results Data
P-Value
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


1 days

 Counts 20.3 18.7 0.26
P-Value
Outcome: catheterization at greater than 48hrs      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 weeks

 Counts 6 2 0.27
N Analyzed 75 74
P-Value P-Value
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


1 years

 Counts 65 67 0.68
N Analyzed 69 69
Percentage 94 97


2 years

 Counts 61 65 0.43
N Analyzed 65 67
Percentage 94 97
P-Value P-Value
Outcome: Overall cure rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 Counts 62 61 1
N Analyzed 69 69
Percentage 89 88


1 years

 Counts 54 56 1
N Analyzed 65 67
Percentage 83 83
P-Value P-Value
Outcome: Subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT-O vs. TVT


1 years

 Counts 63 61 0.77
N Analyzed 69 69
Percentage 91 88


2 years

 Counts 55 56 1
N Analyzed 65 67
Percentage 84 83
P-Value P-Value
Outcome: "other" subjective cure rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 Counts 54 57 0.81
N Analyzed 65 67
Percentage 83 85


1 years

 Counts 57 58 1
N Analyzed 69 69
Percentage 82 84
P-Value
Outcome: Recurrence of incontinence in ISD patients in group      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 Counts 3 4 1
N Analyzed 8 10
Percentage 37 40
P-Value
Outcome: incontinence with intercourse      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 N Analyzed 44 52 1
Counts 0 1
Percentage 0 3
P-Value
Outcome: Peak flow      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

 range 15-24 15-27.75 0.15
median 20 21.50
P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

 range 0-50 0-10.25 0.03
median 10 0
P-Value
Outcome: First voiding desire      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

 range 160-243 151-247 0.70
median 200 201
P-Value
Outcome: MUCP      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


1 years

 range 38-65 3-60 0.94
median 50 50
P-Value
Outcome: Sexual activity satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


2 years

 range 70-100 70-100 not given
median 90 85
P-Value
Outcome: Satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 range 0.66
median 87.7 86.1
P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


2 years

 range no data no data no difference, no p value given
median
P-Value
Outcome: Discomfort associated with bladder outlet obstruction symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


2 years

 range 0-20 0-20 0.66
median 10 5

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 Organ injury in OR (urethra, bladder, bowel) 24 mos in hospital yes seen on cystoscope 6 75 0.68
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Transobturator synthetic 24 mos in hospital yes seen on cystoscope 2 74 0.68
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue erosion required reoperation 24 mos 2 mos yes noted in vagina 0 75 not given
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Transobturator synthetic 24 mos 2 mos yes noted in vagina 1 74 not given
Total
Retropubic synthetic Return to OR 24 mos after yes return to OR 2 75 not given
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Transobturator synthetic 24 mos after yes return to OR 1 74 not given
Total
Retropubic synthetic
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Transobturator synthetic
Total