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Study Title and Description

Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary 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 the treatment of stress urinary incontinence: a randomized controlled trial.
Author Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M
Country --
Year 2008
Numbers Pubmed ID: 18310363
9 (internal)

Secondary Publication Information
UI Title Author Country Year
Risk factors associated with failure 1 year after retropubic or transobturator midurethral slings. Barber MD, Kleeman S, Karram MM, Paraiso MF, Ellerkmann M, Vasavada S, Walters MD -- 2008
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Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 TVT Gynecare
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2 TOT-Monarc AMS Monarc
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Design Details
Question... Follow Up Answer Follow-up Answer
Country US
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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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Urodynamic SUI
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Intrinsic sphincter deficiency
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Mixed incontinence
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Concomitant prolapse surgery
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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 Not reported
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Surgeons' Training Urogynecology
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Residents or fellows performing surgery? Yes
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Study Quality (overall) A (good)
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Study Sponsor/Funding Industry
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Baseline Characteristics
Question TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 88 82
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Mean Age 52 53
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Post-Op Follow-Up Interval (Maximum) 18.2 mo (mean)
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Results & Comparisons


Results Data
P-Value
Outcome: "Normal bladder function"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 88 82 NS
Counts 47 47
Percentage 53.4 57.3
P-Value
Outcome: Negative stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 79 71 NS
Counts 73 62
Percentage 92.4 87.3
P-Value
Outcome: ISI-Dry      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 85 77 NS
Counts 50 48
Percentage 58.8 62.3
P-Value
Outcome: ISI-Slight      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 85 77 NS
Counts 12 9
Percentage 14.1 11.7
P-Value
Outcome: ISI-Moderate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 85 77 NS
Counts 10 13
Percentage 11.8 16.8
P-Value
Outcome: ISI-Severe      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 85 77 NS
Counts 13 7
Percentage 15.3 9.1
P-Value
Outcome: PGII      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 82 75 0.88
Counts 63 61
Percentage 76.8 81.3
P-Value
Outcome: SUI symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 83 73 0.91
Counts 12 11
Percentage 15 15
P-Value
Outcome: UUI symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 81 72 0.61
Counts 29 23
Percentage 36 32
N Enrolled P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 35 30 65
Mean 29 28 0.45
Standard Deviation 10 7
N Enrolled P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 35 30 65
Median 50 30 0.55
Max 500 200
Min 10 5
N Enrolled P-Value
Outcome: Time in hospital-sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 35 30 65
Median 0 0 0.40
Max 2 2
Min 0 0
N Enrolled P-Value
Outcome: Time in hospital-concom surg      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 53 52 105
Median 2 1 0.21
Max 7 7
Min 0 0
N Enrolled P-Value
Outcome: Days until catheter removed-sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 35 30 65
Median 0 1 0.52
25th Percentile 0 0
75th Percentile 2 2
N Enrolled P-Value
Outcome: Days until catheter removed-concom surg      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 53 52 105
Median 5 4 0.19
25th Percentile 1 1.8
75th Percentile 7 6.3
N Enrolled P-Value
Outcome: Change in hematocrit      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 88 82 170
Mean -6.5 -5.2 0.14
Standard Deviation 4 4
N Enrolled P-Value
Outcome: Pads per day      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Median 0 0 0.43
Max 5 6
Min 0 0
N Enrolled P-Value
Outcome: Incontinence episodes per day      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Median 0 0 0.18
Max 16 7
Min 0 0
N Enrolled P-Value
Outcome: PFDI summary score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Mean -67 -67 NS
Standard Deviation 44 44
N Enrolled P-Value
Outcome: PFIQ-7 summary score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Mean -42 -42 NS
Standard Deviation 39 39
N Enrolled P-Value
Outcome: SF-12 PCS summary score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Mean 2 2 NS
Standard Deviation 9 9
N Enrolled P-Value
Outcome: PISQ-12 summary score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Mean 3 3 NS
Standard Deviation 5 5


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic Gynecare TVT
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2 Transobturator synthetic AMS Monarc
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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? No / Not reported
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Results & Comparisons


Results Data
P-Value
Outcome: "Normal bladder function"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 88 82 NS
Counts 47 47
Percentage 53.4 57.3
P-Value
Outcome: Negative stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 79 71 NS
Counts 73 62
Percentage 92.4 87.3
P-Value
Outcome: ISI-Dry      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 85 77 NS
Counts 50 48
Percentage 58.8 62.3
P-Value
Outcome: ISI-Slight      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 85 77 NS
Counts 12 9
Percentage 14.1 11.7
P-Value
Outcome: ISI-Moderate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 85 77 NS
Counts 10 13
Percentage 11.8 16.8
P-Value
Outcome: ISI-Severe      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 85 77 NS
Counts 13 7
Percentage 15.3 9.1
P-Value
Outcome: PGII      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 82 75 0.88
Counts 63 61
Percentage 76.8 81.3
P-Value
Outcome: SUI symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 83 73 0.91
Counts 12 11
Percentage 15 15
P-Value
Outcome: UUI symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Enrolled 81 72 0.61
Counts 29 23
Percentage 36 32
N Enrolled P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 35 30 65
Mean 29 28 0.45
Standard Deviation 10 7
N Enrolled P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 35 30 65
Median 50 30 0.55
Max 500 200
Min 10 5
N Enrolled P-Value
Outcome: Time in hospital-sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 35 30 65
Median 0 0 0.40
Max 2 2
Min 0 0
N Enrolled P-Value
Outcome: Time in hospital-concom surg      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 53 52 105
Median 2 1 0.21
Max 7 7
Min 0 0
N Enrolled P-Value
Outcome: Days until catheter removed-sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 35 30 65
Median 0 1 0.52
25th Percentile 0 0
75th Percentile 2 2
N Enrolled P-Value
Outcome: Days until catheter removed-concom surg      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 53 52 105
Median 5 4 0.19
25th Percentile 1 1.8
75th Percentile 7 6.3
N Enrolled P-Value
Outcome: Change in hematocrit      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


0 months

N Analyzed 88 82 170
Mean -6.5 -5.2 0.14
Standard Deviation 4 4
N Enrolled P-Value
Outcome: Pads per day      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Median 0 0 0.43
Max 5 6
Min 0 0
N Enrolled P-Value
Outcome: Incontinence episodes per day      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Median 0 0 0.18
Max 16 7
Min 0 0
N Enrolled P-Value
Outcome: PFDI summary score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Mean -67 -67 NS
Standard Deviation 44 44
N Enrolled P-Value
Outcome: PFIQ-7 summary score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Mean -42 -42 NS
Standard Deviation 39 39
N Enrolled P-Value
Outcome: SF-12 PCS summary score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Mean 2 2 NS
Standard Deviation 9 9
N Enrolled P-Value
Outcome: PISQ-12 summary score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT-Monarc Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT-Monarc


12 months

N Analyzed 88 82 180
Mean 3 3 NS
Standard Deviation 5 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 Transfusion post-op Intraop In-hospital ND ND 1 88 ND 0.33
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Transobturator synthetic Intraop In-hospital ND ND 0 82 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bladder injury Intraop In-hospital ND ND 7 88 ND 0.02
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Transobturator synthetic Intraop In-hospital ND ND 0 82 ND
Total
Retropubic synthetic Vaginal wall perforation Intraop In-hospital ND ND 1 88 ND 0.33
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Transobturator synthetic Intraop In-hospital ND ND 0 82 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Urethral injury Intraop In-hospital ND ND 0 88 ND 0.99
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Transobturator synthetic Intraop In-hospital ND ND 0 82 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Ureteral injury Intraop In-hospital ND ND 0 88 ND 0.54
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Transobturator synthetic Intraop In-hospital ND ND 1 82 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bowel injury Intraop In-hospital ND ND 0 88 ND 0.99
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Transobturator synthetic Intraop In-hospital ND ND 0 82 ND
Total
Retropubic synthetic Cardiac arrhythmia Intraop In-hospital ND ND 1 88 ND 0.33
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Transobturator synthetic Intraop In-hospital ND ND 0 82 ND
Total
Retropubic synthetic Infection, other Requiring antibiotics <6wk After discahrge ND ND 11 88 ND 0.66
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Transobturator synthetic <6wk After discahrge ND ND 13 82 ND
Total
Retropubic synthetic Infection, UTI <6wk After discahrge ND ND 12 88 ND 0.89
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Transobturator synthetic <6wk After discahrge ND ND 11 82 ND
Total
Retropubic synthetic Cardiac/MI <6wk After discahrge ND ND 0 88 ND 0.99
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Transobturator synthetic <6wk After discahrge ND ND 0 82 ND
Total
Retropubic synthetic Pulmonary complication <6wk After discahrge ND ND 0 88 ND 0.48
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Transobturator synthetic <6wk After discahrge ND ND 1 82 ND
Total
Retropubic synthetic Ileus <6wk After discahrge ND ND 0 88 ND 0.99
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Transobturator synthetic <6wk After discahrge ND ND 0 82 ND
Total
Retropubic synthetic Infection, other Pelvic abscess <6wk After discahrge ND ND 1 88 ND 0.99
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Transobturator synthetic <6wk After discahrge ND ND 1 82 ND
Total
Retropubic synthetic Transfusion post-op beyond intraop <6wk After discahrge ND ND 1 88 ND 0.48
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Transobturator synthetic <6wk After discahrge ND ND 0 82 ND
Total
Retropubic synthetic Pain, groin (new or different after surgery) Leg/obturator complication <6wk After discahrge ND ND 0 88 ND 0.99
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Transobturator synthetic <6wk After discahrge ND ND 0 82 ND
Total
Retropubic synthetic Hospital readmission <6wk After discahrge ND ND 0 88 ND 0.99
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Transobturator synthetic <6wk After discahrge ND ND 0 82 ND
Total
Retropubic synthetic ER evaluation <6wk After discahrge ND ND 2 88 ND 0.67
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Transobturator synthetic <6wk After discahrge ND ND 4 82 ND
Total
Retropubic synthetic Pain, unspecified area (new or different after surgery) VAS 0-10, median (range) Day1 In-hospital ND ND 4 (0-9) 88 ND 0.45
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Transobturator synthetic Day1 In-hospital ND ND 4 (0-9) 82 ND
Total
Retropubic synthetic VAS 0-10, median (range) Day3 After discahrge ND ND 3 (0-8) 88 ND 0.08
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Transobturator synthetic Day3 After discahrge ND ND 2 (0-8) 82 ND
Total
Retropubic synthetic VAS 0-10, median (range) Day7 After discahrge ND ND 2 (0-7) 88 ND 0.11
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Transobturator synthetic Day7 After discahrge ND ND 1 (0-6) 82 ND
Total
Retropubic synthetic VAS 0-10, median (range) 6 wk After discahrge ND ND 0 (0-7) 88 ND 0.38
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Transobturator synthetic 6 wk After discahrge ND ND 0 (0-3) 82 ND
Total
Retropubic synthetic Retention requiring surgery Sling release >6wk After discahrge ND ND 1 85 ND NS
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Transobturator synthetic >6wk After discahrge ND ND 0 77 ND
Total
Retropubic synthetic Catheterization >6wk >6wk After discahrge ND ND 4 85 ND NS
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Transobturator synthetic >6wk After discahrge ND ND 2 77 ND
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue 12mo After discahrge ND ND 5 88 ND 0.24
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Transobturator synthetic 12mo After discahrge ND ND 1 82 ND
Total