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Study Title and Description

Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial.



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 tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial.
Author Ross S., Robert M., Swaby C., Dederer L., Lier D., Tang S., Brasher P., Birch C., Cenaiko D., Mainprize T., Murphy M., Carlson K., Baverstock R., Jacobs P., Williamson T.
Country Department of Obstetrics and Gynaecology, University of Calgary, Calgary, Alberta, Canada. sue.ross@albertahealthservices.ca
Year 2009
Numbers Pubmed ID: 19935032
886 (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 TOT_out-to-in Obtryx by Boston Scientific
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2 TVT "Advantage" retropubic MUS (Boston Sci)
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Canada
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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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RCT Comparison Category Retropubic vs. Obturator
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures ... Other ... 7
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Surgeons' Training Urogynecology
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Urology
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Other ... Ob/Gyn
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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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Study Sponsor/Funding Industry
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Baseline Characteristics
Question TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 94 105
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Mean Age 50.1 51.8
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Post-Op Follow-Up Interval (Maximum) 12 mo 12 mo
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Results & Comparisons


Results Data
P-Value
Outcome: Not admitted      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Enrolled 94 105 0.238
Counts 87 88
Percentage 92.5 83.8
P-Value
Outcome: Emergent (unplanned) admission      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Enrolled 94 105 0.238
Counts 3 6
Percentage 3.2 5.7
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Pad test "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 84 87 0.577
Counts 68 67 1.05
Percentage 81.0 77.0 0.90
1.23
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: SUI Sx - none or no problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.213
Counts 85 88 1.04
Percentage 98.8 92.6 0.99
1.10
P-Value
Outcome: SUI Sx - yes, big problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.213
Counts 1 5
Percentage 1.2 5.3
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: UUI Sx - none or no problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.747
Counts 82 84 1.02
Percentage 95.3 88.4 0.95
1.10
P-Value
Outcome: UUI Sx - yes, big problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.747
Counts 4 4
Percentage 4.7 4.2
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Nocturia - none or no problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.243
Counts 75 82 0.95
Percentage 87.2 86.3 0.87
1.03
P-Value
Outcome: Nocturia - yes, big problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.243
Counts 8 4
Percentage 9.3 4.2
P-Value
Outcome: Return to usual sexual activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


2 months

N Enrolled 86 95 0.766
Counts 58 54
Percentage 67.4 56.8
P-Value
Outcome: "Met expectations"      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.133
Counts 78 80
Percentage 90.7 84.2
P-Value
Outcome: Would recommend to friend      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.622
Counts 82 88
Percentage 95.4 92.6
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Analyzed 94 105 0.676
Median 19 18
Max 23 23
Min 16 16
P-Value P-Value
Outcome: UDI-6      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Analyzed 85 95 NS
Median 37 41


12 months

N Analyzed 85 95 NS
Median 3 11
Max 11 22
Min 0 0
P-Value P-Value
Outcome: IIQ-7      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Analyzed 86 95 NS
Median 30 30


12 months

N Analyzed 86 95 NS
Median 0 0
Max 5 10
Min 0 0


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Transobturator synthetic Obtryx Halo
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2 Retropubic synthetic Advantage retropubic sling
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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 Industry
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Results & Comparisons


Results Data
P-Value
Outcome: Not admitted      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Enrolled 94 105 0.238
Counts 87 88
Percentage 92.5 83.8
P-Value
Outcome: Emergent (unplanned) admission      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Enrolled 94 105 0.238
Counts 3 6
Percentage 3.2 5.7
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Pad test "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 84 87 0.577
Counts 68 67 1.05
Percentage 81.0 77.0 0.90
1.23
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: SUI Sx - none or no problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.213
Counts 85 88 1.04
Percentage 98.8 92.6 0.99
1.10
P-Value
Outcome: SUI Sx - yes, big problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.213
Counts 1 5
Percentage 1.2 5.3
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: UUI Sx - none or no problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.747
Counts 82 84 1.02
Percentage 95.3 88.4 0.95
1.10
P-Value
Outcome: UUI Sx - yes, big problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.747
Counts 4 4
Percentage 4.7 4.2
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Nocturia - none or no problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.243
Counts 75 82 0.95
Percentage 87.2 86.3 0.87
1.03
P-Value
Outcome: Nocturia - yes, big problem      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.243
Counts 8 4
Percentage 9.3 4.2
P-Value
Outcome: Return to usual sexual activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


2 months

N Enrolled 86 95 0.766
Counts 58 54
Percentage 67.4 56.8
P-Value
Outcome: "Met expectations"      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.133
Counts 78 80
Percentage 90.7 84.2
P-Value
Outcome: Would recommend to friend      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


12 months

N Enrolled 86 95 0.622
Counts 82 88
Percentage 95.4 92.6
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Analyzed 94 105 0.676
Median 19 18
Max 23 23
Min 16 16
P-Value P-Value
Outcome: UDI-6      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Analyzed 85 95 NS
Median 37 41


12 months

N Analyzed 85 95 NS
Median 3 11
Max 11 22
Min 0 0
P-Value P-Value
Outcome: IIQ-7      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT Transobturator synthetic Retropubic synthetic Comparison Measure TOT_out-to-in vs. TVT


0 months

N Analyzed 86 95 NS
Median 30 30


12 months

N Analyzed 86 95 NS
Median 0 0
Max 5 10
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
Transobturator synthetic Organ injury in OR (urethra, bladder, bowel) Bladder perforation Intraop In-hospital ND ND 0 94 ND NS
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Retropubic synthetic Intraop In-hospital ND ND 3 105
Total
Transobturator synthetic EBL >200mL Intraop In-hospital ND ND 0 94 ND NS
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Retropubic synthetic Intraop In-hospital ND ND 3 105
Total
Transobturator synthetic Return to OR "Release of tape or surgery for mesh extrusion" 12mo After discharge ND ND 7 85 RR 1.47 (0.49-4.44) 0.559
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Retropubic synthetic 12mo After discharge ND ND 5 90
Total
Transobturator synthetic Retention requiring surgery 12mo After discharge ND ND 3 85 ND NS
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Retropubic synthetic 12mo After discharge ND ND 1 90
Total
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue Requiring surgery 12mo After discharge ND ND 1 85 ND NS
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Retropubic synthetic 12mo After discharge ND ND 1 90
Total
Transobturator synthetic Abnormal exam Abnormal palpation on vaginal exam 12mo After discharge ND ND 68 85 ND <0.001
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Retropubic synthetic 12mo After discharge ND ND 24 90
Total
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue Noted on exam 12mo After discharge ND ND 5 85 ND ND
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Retropubic synthetic 12mo After discharge ND ND 0 90
Total
Transobturator synthetic Pain, groin (new or different after surgery) 12mo After discharge ND ND 13 85 ND 0.044
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Retropubic synthetic 12mo After discharge ND ND 5 90
Total