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Study Title and Description

What patients think: Patient reported outcomes of retropubic versus transobturator mid-urethral slings for urodynamic stress incontinence - a multicentre randomised 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 What patients think: Patient reported outcomes of retropubic versus transobturator mid-urethral slings for urodynamic stress incontinence - a multicentre randomised controlled trial
Author Freeman, Holmes, Hillard, Smith, James, Sultan, Morley, Yang, Abrams
Country
Year 2011
Numbers Pubmed ID: 21222114
2413 (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 Monarc
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2 TVT
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Design Details
Question... Follow Up Answer Follow-up Answer
Country UK
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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 Unclear/Not reported
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Number of surgeons performing procedures ... Other ... many
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Surgeons' Training Not reported
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Residents or fellows performing surgery? Unclear/Not reported
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Overall Study Notes non-inferiority design; did meet power; did not always provide between-arm p values (OR time for example)
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Study Sponsor/Funding ... Other ... not stated
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Baseline Characteristics
Question Monarc TVT Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 100 93 193
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Mean Age 54 (median) 50 (median)
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Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos
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Results & Comparisons


Results Data
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: Sexual function      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 94 85
Mean
Counts 1 1 not significant difference
Percentage 1.1% 1.2%
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Enrolled 95 85
Counts 59 55 -13.88-9.80
Percentage 63.4% 65.5%
Enter a Title Here
Outcome: SUI objective      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Enrolled 95 85 no difference, p value not given
Percentage 10% 12%
Statistical Test: Enter a Title Here P-Value
Outcome: UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure Monarc vs. TVT


12 months

N Enrolled 85 95 Fisher's exact
Percentage 62.4% 60.7%
0.88
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: SUI want retreatment      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed
Mean
Counts not significant diff
Percentage 10.% 15.3%
Statistical Test: P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


0 days

N Analyzed 96 83
Mean 48.7 61.7 0.037
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: de novo ugency      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 95 85
Mean
Counts 4 4 no p value given
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: voiding difficulty requiring catheterization      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 95 85
Mean
Counts 5 5 no p value - stated not different
ISC at 1 yr 2 1
N Enrolled P-Value Statistical Test:
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


6 hours

N Analyzed 76 68
Mean 3.1 3.7 0.06
Standard Deviation
N Enrolled P-Value Statistical Test:
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


24 hours

N Analyzed 88 75
Mean 1.9 2.4 0.031
Standard Deviation
N Enrolled P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 91 83
Mean 3.1 3.3 .70
Mann-Whitney
Outcome: SUI treatment meets expectations      Population: All Participants
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic


12 months

N Analyzed 85 71
Mean
Counts 56 58
Percentage 58.9% 68.2%


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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Study Country UK
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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? No / Not reported
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Results & Comparisons


Results Data
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: Sexual function      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 94 85
Mean
Counts 1 1 not significant difference
Percentage 1.1% 1.2%
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Enrolled 95 85
Counts 59 55 -13.88-9.80
Percentage 63.4% 65.5%
Enter a Title Here
Outcome: SUI objective      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Enrolled 95 85 no difference, p value not given
Percentage 10% 12%
Statistical Test: Enter a Title Here P-Value
Outcome: UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure Monarc vs. TVT


12 months

N Enrolled 85 95 Fisher's exact
Percentage 62.4% 60.7%
0.88
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: SUI want retreatment      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed
Mean
Counts not significant diff
Percentage 10.% 15.3%
Statistical Test: P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


0 days

N Analyzed 96 83
Mean 48.7 61.7 0.037
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: de novo ugency      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 95 85
Mean
Counts 4 4 no p value given
Statistical Test: 95% Confidence Interval Lower Limit (95% LCI) Enter a Title Here
Outcome: voiding difficulty requiring catheterization      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 95 85
Mean
Counts 5 5 no p value - stated not different
ISC at 1 yr 2 1
N Enrolled P-Value Statistical Test:
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


6 hours

N Analyzed 76 68
Mean 3.1 3.7 0.06
Standard Deviation
N Enrolled P-Value Statistical Test:
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


24 hours

N Analyzed 88 75
Mean 1.9 2.4 0.031
Standard Deviation
N Enrolled P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 91 83
Mean 3.1 3.3 .70
Mann-Whitney
Outcome: SUI treatment meets expectations      Population: All Participants
Time Point Measure Monarc TVT Retropubic synthetic Transobturator synthetic


12 months

N Analyzed 85 71
Mean
Counts 56 58
Percentage 58.9% 68.2%

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) bladder perforation 12 mos OR no not given 2 85 not different none given
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Transobturator synthetic 12 mos OR no not given 0 95 not different none given
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) vaginal perforation 12 mos OR no not given 0 85 not different none given
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Transobturator synthetic 12 mos OR no not given 4 95 not different none given
Total
Retropubic synthetic Pain, groin (new or different after surgery) 12 mos postop no not given 1 85 not different none given
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Transobturator synthetic 12 mos postop no not given 8 95 not different none given
Total
Retropubic synthetic removal for pain removal of tape for pain 12 mos postop somewhat not given 0 85 not different none given
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Transobturator synthetic 12 mos postop somewhat not given 1 95 not different none given
Total
Retropubic synthetic removal for exposure removal for mesh exposure 12 mos postop no not given 0 85 not different none given
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Transobturator synthetic 12 mos postop no not given 1 95 not different none given
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue 12 mos postop no not given 3 85 not different none given
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Transobturator synthetic 12 mos postop no not given 2 95 not different none given
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Retropubic synthetic Infection, UTI required antibiotic therapy 12 mos postop no not given 7 85 not different none given
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Transobturator synthetic 12 mos postop no not given 2 95 not different none given
Total
Retropubic synthetic Infection, other vaginal infection/discharge 12 mos postop no not given 0 85 not different none given
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Transobturator synthetic 12 mos postop no not given 4 95 not different none given
Total
Retropubic synthetic Infection, surgical site/wound 12 mos postop no not given 0 85 not different none given
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Transobturator synthetic 12 mos postop no not given 2 95 not different none given
Total
Retropubic synthetic
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Transobturator synthetic
Total