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Study Title and Description

Single-incision mini-sling compared to TVT for the treatment of SUI



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 Single-incision mini-sling compared to TVT for the treatment of SUI
Author Barber et al
Country --
Year 2012
Numbers Pubmed ID: 22270285
57 (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-Secur U
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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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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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RCT Comparison Category Minisling vs. Other
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Multicenter Yes
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Institution Type Academic hospital
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Number of surgeons performing procedures ... Other ... 7 institutions, # surgeons not specifically 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 well-designed, well-reported, good randomization scheme, non-inferiority design, powered for 12% difference in subjective cure at 12 mos between slings. Blinding maintained. Surgeons had to have done 5 minislings before trial but had "significant" TVT experience. Possible question of experience impacting results.
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Study Sponsor/Funding ... Other ... Foundation for Female Health Awareness
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Baseline Characteristics
Question TVT TVT-Secur U Minisling retropubic Retropubic synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 127 136 263
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Mean Age 55 55 55
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Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos 19.6 mos
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Results & Comparisons


Results Data
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) mean difference
Outcome: subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 127 129 .60
Percentage 60.6 55.8 -16.7
Counts 77 72 7.2
-4.8
P-Value
Outcome: Discharge date = date of OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Enrolled 127 133 0.60
Percentage 60.6 59.5
P-Value
Outcome: Catheter removed prior to discharge      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Enrolled 127 133 0.008
Percentage 63.0 78.5
P-Value
Outcome: persistent voiding dysfunction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Enrolled 127 133 0.67
Percentage 2.4 1.7
P-Value
Outcome: Retreatment for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 127 136 0.43
Percentage 2.4 1.5
Counts 3 2
P-Value
Outcome: Obj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

Percentage 24 29 0.36
P-Value
Outcome: subj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 years

N Enrolled 101 107 0.36
Percentage 94 91
Counts 95 76
P-Value
Outcome: subj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 103 109 0.36
Percentage 14 19
Counts 15 21
P-Value
Outcome: subj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 103 109 0.36
Percentage 14 18
Counts 14 20
P-Value
Outcome: UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 103 108 0.46
Percentage 32 28
Counts 33 30
P-Value
Outcome: UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 103 108 0.54
Percentage 29 25
Counts 30 27
P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 105 109 0.64
Percentage 64 58
Counts 67 63
Outcome: Subj cure SUI      Population: All Participants
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic


1 years

N Enrolled
Percentage
Counts
P-Value
Outcome: Retreatment for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 127 136 0.43
Percentage 2.4 1.5
Counts 3 2
P-Value
Outcome: Severity of incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

N Enrolled 126 134 0.025
Percentage 5 16
Counts 6 21
N Enrolled P-Value
Outcome: OR time for sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 days

N Analyzed 127 133
Mean 28 26 0.26
Standard Deviation 10 12
N Enrolled P-Value
Outcome: OR time total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Analyzed 127 133
Mean 77 77 0.58
Standard Deviation 70 81
N Enrolled P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Analyzed 127 133
Median 50 50 0.33
Max 600 600
Min 0 0
N Enrolled P-Value
Outcome: incontinence symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 years

Mean 1.5 2.2
Standard Deviation 1.9 2.7 0.015
N Enrolled P-Value
Outcome: Obj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 years

Median 0 0
25th Percentile 0 0 0.41
75th Percentile 1 1.8
N Enrolled P-Value
Outcome: Obj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 years

Median 0 0
25th Percentile 0 0 0.38
75th Percentile 0.5 3
N Enrolled P-Value
Outcome: sex function      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

Mean data not shown data not shown
Standard Deviation improved significant from baseline in both groups, no difference between groups
N Enrolled P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

Mean significant for whole study compared to baseline significant for whole study compared to baseline
Standard Deviation no sig diff between groups
N Enrolled P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

Mean significant for whole study compared to baseline significant for whole study compared to baseline
Standard Deviation no sig diff between groups
P-Value P-Value P-Value P-Value P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Analyzed 127 133 <0.05
Median 6 5


2 days

N Analyzed 127 133 <0.05
Median 5 4


3 days

N Analyzed 127 133 <0.05
Median 4 2


14 days

N Analyzed 127 133 no diff
Median not given not given


6 weeks

N Analyzed 127 133 no diff
Median not given not given
N Enrolled P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 weeks

N Analyzed 127 133
Median not given not given .89
Max
Min


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling retropubic TVT Secur U
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2 Retropubic synthetic TVT
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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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Minsling U (retropubic)
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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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Study Sponsor/Funding ... Other ...
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Results & Comparisons


Results Data
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) mean difference
Outcome: subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 127 129 .60
Percentage 60.6 55.8 -16.7
Counts 77 72 7.2
-4.8
P-Value
Outcome: Discharge date = date of OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Enrolled 127 133 0.60
Percentage 60.6 59.5
P-Value
Outcome: Catheter removed prior to discharge      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Enrolled 127 133 0.008
Percentage 63.0 78.5
P-Value
Outcome: persistent voiding dysfunction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Enrolled 127 133 0.67
Percentage 2.4 1.7
P-Value
Outcome: Retreatment for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 127 136 0.43
Percentage 2.4 1.5
Counts 3 2
P-Value
Outcome: Obj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

Percentage 24 29 0.36
P-Value
Outcome: subj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 years

N Enrolled 101 107 0.36
Percentage 94 91
Counts 95 76
P-Value
Outcome: subj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 103 109 0.36
Percentage 14 19
Counts 15 21
P-Value
Outcome: subj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 103 109 0.36
Percentage 14 18
Counts 14 20
P-Value
Outcome: UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 103 108 0.46
Percentage 32 28
Counts 33 30
P-Value
Outcome: UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 103 108 0.54
Percentage 29 25
Counts 30 27
P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 105 109 0.64
Percentage 64 58
Counts 67 63
Outcome: Subj cure SUI      Population: All Participants
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic


1 years

N Enrolled
Percentage
Counts
P-Value
Outcome: Retreatment for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 years

N Enrolled 127 136 0.43
Percentage 2.4 1.5
Counts 3 2
P-Value
Outcome: Severity of incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

N Enrolled 126 134 0.025
Percentage 5 16
Counts 6 21
N Enrolled P-Value
Outcome: OR time for sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT-Secur U vs. TVT


1 days

N Analyzed 127 133
Mean 28 26 0.26
Standard Deviation 10 12
N Enrolled P-Value
Outcome: OR time total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Analyzed 127 133
Mean 77 77 0.58
Standard Deviation 70 81
N Enrolled P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Analyzed 127 133
Median 50 50 0.33
Max 600 600
Min 0 0
N Enrolled P-Value
Outcome: incontinence symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 years

Mean 1.5 2.2
Standard Deviation 1.9 2.7 0.015
N Enrolled P-Value
Outcome: Obj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 years

Median 0 0
25th Percentile 0 0 0.41
75th Percentile 1 1.8
N Enrolled P-Value
Outcome: Obj cure SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 years

Median 0 0
25th Percentile 0 0 0.38
75th Percentile 0.5 3
N Enrolled P-Value
Outcome: sex function      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

Mean data not shown data not shown
Standard Deviation improved significant from baseline in both groups, no difference between groups
N Enrolled P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

Mean significant for whole study compared to baseline significant for whole study compared to baseline
Standard Deviation no sig diff between groups
N Enrolled P-Value
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

Mean significant for whole study compared to baseline significant for whole study compared to baseline
Standard Deviation no sig diff between groups
P-Value P-Value P-Value P-Value P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 days

N Analyzed 127 133 <0.05
Median 6 5


2 days

N Analyzed 127 133 <0.05
Median 5 4


3 days

N Analyzed 127 133 <0.05
Median 4 2


14 days

N Analyzed 127 133 no diff
Median not given not given


6 weeks

N Analyzed 127 133 no diff
Median not given not given
N Enrolled P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur U Minisling retropubic Retropubic synthetic Comparison Measure TVT vs. TVT-Secur U


1 weeks

N Analyzed 127 133
Median not given not given .89
Max
Min

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
Minisling retropubic Organ injury in OR (urethra, bladder, bowel) Bladder 12 mos in hospital yes 6 136 0.046
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Retropubic synthetic 12 mos in hospital yes 1 127 0.046
Total
Minisling retropubic Organ injury in OR (urethra, bladder, bowel) Bowel 12 mos in hospital yes 1 136 0.61
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Retropubic synthetic 12 mos in hospital yes 2 127 0.61
Total
Minisling retropubic Transfusion post-op 6 wk both yes 1 136 NS
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Retropubic synthetic 6 wk both yes 1 127 NS
Total
Minisling retropubic Infection, UTI 6 wk after 9 136 0.89
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Retropubic synthetic 6 wk after 9 127 0.89
Total
Minisling retropubic Mesh erosion/extrusion/exposure/granulation tissue managed without surgery 6 wk after 0 136 0.32
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Retropubic synthetic 6 wk after 1 127 0.32
Total
Minisling retropubic Retention requiring surgery 12 mos after yes 2 136 0.67
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Retropubic synthetic 12 mos after yes 3 127 0.67
Total
Minisling retropubic Infection, other requires antibiotics 6 wk after 5 136 0.76
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Retropubic synthetic 6 wk after 6 127 0.76
Total