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Study Title and Description

Twelve months effect on voiding function of retropubic compared with outside-in and inside-out transobturator midurethral slings.



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 Twelve months effect on voiding function of retropubic compared with outside-in and inside-out transobturator midurethral slings.
Author Scheiner DA., Betschart C., Wiederkehr S., Seifert B., Fink D., Perucchini D.
Country Department of Gynecology, University Hospital Zurich, Frauenklinikstrasse 10, 8091 Zurich, Switzerland. david.scheiner@usz.ch
Year 2012
Numbers Pubmed ID: 21887548
39 (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 Retropubic (Gynecare)
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2 Monarc Transobturator (outside-in; AMS)
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3 TVT-O Transobturator (inside-out; Gynecare)
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Switzerland
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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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Other ... "Two public teaching hospitals"
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Number of surgeons performing procedures ... Other ... 9
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Surgeons' Training Urogynecology
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General
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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 Study stopped early due to unexpected finding of de novo female sexual dysfunction (FSD) in Monarc group, therefore did not meet the N (=200) to achieve power based on the power calculation.
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Study Sponsor/Funding ... Other ... "no funding received"
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Baseline Characteristics
Question TVT Monarc TVT-O TVT Monarc TVT-O Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 80 40 40 160
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Mean Age 57.8 56.6 59.3 not reported
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Post-Op Follow-Up Interval (Maximum) 12 months 12 months 12 months 12 months
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: Objective continence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 65 34 37 Fisher's exact
Counts 58 31 33 0.72
Percentage 93.6 91.2 89.2
Statistical Test: P-Value
Outcome: Subjective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 65 34 37 Kruskal Wallis
Counts 57 28 29 0.77
Percentage 87.7 82.4 78.4
Statistical Test: P-Value
Outcome: Micturition      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 65 34 37 Fisher's exact
Counts 53 30 33 0.71
Percentage 81.5 88.2 86.5
Statistical Test: P-Value
Outcome: sexual dysfunction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 52 29 25 Fishers
Counts 1 5 0 0.011
Percentage 1.9 17.2 0
P-Value Statistical Test:
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 65 34 37 0.66
Mean 14.2 14.2 18.1 Kruskal Wallis
Standard Deviation 22.4 25.6 25.2
Max 100 120 120
Min 0 0 0
P-Value Statistical Test:
Outcome: Q max      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 65 34 37 Kruskal Wallis
Mean 20.4 23.5 20.6 0.26
Standard Deviation 8.1 9.0 6.9
Max 40.1 44.9 33.7
Min 6.5 5.1 7.4
P-Value Statistical Test:
Outcome: VAS - incontinence impact      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.21
Mean 0.7 1.2 1.3 Kruskal Wallis
Standard Deviation 1.3 1.7 1.8
Max 6 5 7
Min 0 0 0
P-Value Statistical Test:
Outcome: King's Health Questionnaire Incontinence Impact      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 47 28 28 Kruskal Wallis
Mean 8.5 11.9 10.7 0.95
Standard Deviation 14.7 22.6 18.6
Max 33.3 66.7 66.7
Min 0 0 0
P-Value Statistical Test:
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


1 days

N Analyzed 80 40 40 0.68
Mean 26.7 25.8 27.4 Kruskal-Wallis
Standard Deviation 11.5 9.7 10
Max 100 50 54
Min 15 15 15
P-Value Statistical Test:
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


1 days

N Analyzed 80 40 40 0.96
Mean 34.4 31.5 49.4 Kruskal Wallis
Standard Deviation 36.5 22.2 89.6
Max 250 100 500
Min 5 10 10
P-Value Statistical Test:
Outcome: Hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


1 days

N Analyzed 80 40 40 0.14
Mean 3.5 3.2 3.3 Kruskal Wallis
Standard Deviation 1.1 0.5 0.8
Max 10 5 6
Min 3 3 3
P-Value Statistical Test:
Outcome: KHQ general health perception      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.85
Mean 22.3 22.3 25.0 Kruskal Wallis
Standard Deviation 18.4 19.6 20.8
Max 75 75 75
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ role limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.70
Mean 4.6 6.8 6.0 Kruskal Wallis
Standard Deviation 11.4 17.5 12.6
Max 33.3 66.7 50
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ personal limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.38
Mean 5.3 6.0 4.9 Kruskal Wallis
Standard Deviation 12.1 20.9 7.7
Max 50 100 16.7
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ social limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.77
Mean 1.7 6.0 1.4 Kruskal Wallis
Standard Deviation 6.6 20.4 5.0
Max 33.3 100 22.2
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ personal relations      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.66
Mean 3.2 7.1 3.1 Kruskal Wallis
Standard Deviation 8.0 18.7 9.1
Max 33.3 83.3 33.3
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ emotional problems      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.75
Mean 2.4 2.8 5.8 Kruskal Wallis
Standard Deviation 7.3 7.8 15.4
Max 33.3 33.3 66.7
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ sleep and energy      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.91
Mean 4.3 6.5 6.7 Kruskal Wallis
Standard Deviation 8.1 13.1 12.7
Max 33.3 50 33.3
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ severity measures      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.86
Mean 16.4 17.5 17.3 Kruskal Wallis
Standard Deviation 20.3 22.1 17.8
Max 86.7 100 53.3
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ overactive bladder      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.90
Mean 3.9 5.2 4.9 Kruskal Wallis
Standard Deviation 13.0 19.3 14.5
Max 66.7 83.3 50
Min 0 0 0


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 TVT Retropubic - Gynecare
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2 Monarc Transobturator (outside-in; AMS)
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3 TVT-O Transobturator (inside-out; Gynecare)
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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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Multicenter? Yes
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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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Comments (overall study) Higher than expected rate of FSD (female sexual dysfunction) in Monarc group led to stopping the trial prematurely
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: Objective continence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 65 34 37 Fisher's exact
Counts 58 31 33 0.72
Percentage 93.6 91.2 89.2
Statistical Test: P-Value
Outcome: Subjective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 65 34 37 Kruskal Wallis
Counts 57 28 29 0.77
Percentage 87.7 82.4 78.4
Statistical Test: P-Value
Outcome: Micturition      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 65 34 37 Fisher's exact
Counts 53 30 33 0.71
Percentage 81.5 88.2 86.5
Statistical Test: P-Value
Outcome: sexual dysfunction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Enrolled 52 29 25 Fishers
Counts 1 5 0 0.011
Percentage 1.9 17.2 0
P-Value Statistical Test:
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 65 34 37 0.66
Mean 14.2 14.2 18.1 Kruskal Wallis
Standard Deviation 22.4 25.6 25.2
Max 100 120 120
Min 0 0 0
P-Value Statistical Test:
Outcome: Q max      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 65 34 37 Kruskal Wallis
Mean 20.4 23.5 20.6 0.26
Standard Deviation 8.1 9.0 6.9
Max 40.1 44.9 33.7
Min 6.5 5.1 7.4
P-Value Statistical Test:
Outcome: VAS - incontinence impact      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.21
Mean 0.7 1.2 1.3 Kruskal Wallis
Standard Deviation 1.3 1.7 1.8
Max 6 5 7
Min 0 0 0
P-Value Statistical Test:
Outcome: King's Health Questionnaire Incontinence Impact      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 47 28 28 Kruskal Wallis
Mean 8.5 11.9 10.7 0.95
Standard Deviation 14.7 22.6 18.6
Max 33.3 66.7 66.7
Min 0 0 0
P-Value Statistical Test:
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


1 days

N Analyzed 80 40 40 0.68
Mean 26.7 25.8 27.4 Kruskal-Wallis
Standard Deviation 11.5 9.7 10
Max 100 50 54
Min 15 15 15
P-Value Statistical Test:
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


1 days

N Analyzed 80 40 40 0.96
Mean 34.4 31.5 49.4 Kruskal Wallis
Standard Deviation 36.5 22.2 89.6
Max 250 100 500
Min 5 10 10
P-Value Statistical Test:
Outcome: Hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


1 days

N Analyzed 80 40 40 0.14
Mean 3.5 3.2 3.3 Kruskal Wallis
Standard Deviation 1.1 0.5 0.8
Max 10 5 6
Min 3 3 3
P-Value Statistical Test:
Outcome: KHQ general health perception      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.85
Mean 22.3 22.3 25.0 Kruskal Wallis
Standard Deviation 18.4 19.6 20.8
Max 75 75 75
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ role limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.70
Mean 4.6 6.8 6.0 Kruskal Wallis
Standard Deviation 11.4 17.5 12.6
Max 33.3 66.7 50
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ personal limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.38
Mean 5.3 6.0 4.9 Kruskal Wallis
Standard Deviation 12.1 20.9 7.7
Max 50 100 16.7
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ social limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.77
Mean 1.7 6.0 1.4 Kruskal Wallis
Standard Deviation 6.6 20.4 5.0
Max 33.3 100 22.2
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ personal relations      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.66
Mean 3.2 7.1 3.1 Kruskal Wallis
Standard Deviation 8.0 18.7 9.1
Max 33.3 83.3 33.3
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ emotional problems      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.75
Mean 2.4 2.8 5.8 Kruskal Wallis
Standard Deviation 7.3 7.8 15.4
Max 33.3 33.3 66.7
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ sleep and energy      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.91
Mean 4.3 6.5 6.7 Kruskal Wallis
Standard Deviation 8.1 13.1 12.7
Max 33.3 50 33.3
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ severity measures      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.86
Mean 16.4 17.5 17.3 Kruskal Wallis
Standard Deviation 20.3 22.1 17.8
Max 86.7 100 53.3
Min 0 0 0
P-Value Statistical Test:
Outcome: KHQ overactive bladder      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Monarc TVT-O TVT Monarc TVT-O Comparison Measure All Arms (ANOVA)


12 months

N Analyzed 47 28 28 0.90
Mean 3.9 5.2 4.9 Kruskal Wallis
Standard Deviation 13.0 19.3 14.5
Max 66.7 83.3 50
Min 0 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
TVT Organ injury in OR (urethra, bladder, bowel) "Bladder perforation" Intraop In hospital No Not defined 3 80 0.43
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Monarc Intraop In hospital No Not defined 0 40 0.43
TVT-O Intraop In hospital No Not defined 0 40 0.43
Total
TVT Organ injury in OR (urethra, bladder, bowel) "vaginal perforation" Intraop In hospital No Not defined 1 80 0.0006
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Monarc Intraop In hospital No Not defined 6 40 0.0006
TVT-O Intraop In hospital No Not defined 4 40 0.0006
Total
TVT "Haemorrhage" "Haemorrhage in the retropubic space required laparotomy the next day" Postop In hospital Yes Not defined 1 80 1.0
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Monarc Postop In hospital Yes Not defined 0 40 1.0
TVT-O Postop In hospital Yes Not defined 0 40 1.0
Total
TVT Obstruction requiring reoperation "Postoperative interventions due to voiding obstruction - EARLY (tape loosening within the first week)" Postop After discharge No Not defined 1 80 1.0
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Monarc Postop After discharge No Not defined 1 40 1.0
TVT-O Postop After discharge No Not defined 0 40 1.0
Total
TVT Obstruction requiring reoperation "Postoperative interventions due to voiding obstruction - LATE (tape release procedure within 12 months by complete excision, including partial excision)" Postop After discharge No Not defined 2 80 0.81
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Monarc Postop After discharge No Not defined 0 40 0.81
TVT-O Postop After discharge No Not defined 1 40 0.81
Total
TVT Second sling insertion "second sling insertion" Postop After discharge No Not defined 1 80 1.0
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Monarc Postop After discharge No Not defined 1 40 1.0
TVT-O Postop After discharge No Not defined 0 40 1.0
Total
TVT Mesh erosion/extrusion/exposure/granulation tissue "vaginal tape exposure" Postop After discharge No Not defined 1 80 0.028
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Monarc Postop After discharge No Not defined 4 40 0.028
TVT-O Postop After discharge No Not defined 0 40 0.028
Total
TVT Pain, groin (new or different after surgery) "thigh or groin pain" Postop After discharge No Not defined 1 80 0.23
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Monarc Postop After discharge No Not defined 3 40 0.23
TVT-O Postop After discharge No Not defined 1 40 0.23
Total