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Study Title and Description

A prospective multicenter randomized comparative study between the U- and H-type methods of the TVT SECUR procedure for the treatment of female stress urinary incontinence: 1-year follow-up.



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 A prospective multicenter randomized comparative study between the U- and H-type methods of the TVT SECUR procedure for the treatment of female stress urinary incontinence: 1-year follow-up.
Author Lee KS., Lee YS., Seo JT., Na YG., Choo MS., Kim JC., Seo JH., Yoon JM., Lee JG., Kim DY., Yoo ES., Min KS., Hong JY., Lee JZ.
Country Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Year 2010
Numbers Pubmed ID: 20206437

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-Secur H
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2 TVT-Secur U
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Design Details
Question... Follow Up Answer Follow-up Answer
Country South Korea
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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 Minisling vs. Other
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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 ... Other ... 13
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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 Reports women were randomly allocated in OR but age, menopausal status, DO status and urgency episodes were different between groups. "The center applied a stratified permuted block randomization method. Patients who had a standing stress test at baseline and the 12-mo postoperative visits consisted of the efficacy set. The safety set consisted of all participants who received the study procedure." Numbers between groups reasonably balanced, suggesting equal distribution. 12 mo outcomes, good outcome measures. Cystoscopy only done in U group.
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Study Sponsor/Funding ... Other ... reports "funding: none"
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Baseline Characteristics
Question TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 165 165 330
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Mean Age 53 55 54
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Post-Op Follow-Up Interval (Maximum) 12 mo 12 mo 12 mo
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: Obj cure rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.091
Percentage 80.1 87.5
Counts 113 126
Statistical Test: P-Value
Outcome: Subj cure rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.786
Percentage 75.7 77.1
Counts 106 111
Statistical Test: P-Value
Outcome: Achieved goal for surgery      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.546
Percentage 78.2 83.8
Statistical Test: P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.858
Percentage 7.6 7.0
Statistical Test: P-Value
Outcome: "would recommend to a friend"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144
Mean 85 90 0.026
Statistical Test: P-Value
Outcome: "satisfaction"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144
Mean 0.037
Percentage 77 87
Statistical Test: P-Value
Outcome: "would have this surgery again"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.002
Percentage 78 90
Statistical Test: P-Value
Outcome: perception of treatment benefit      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.53
Percentage 75 85
Statistical Test: P-Value
Outcome: urgency incontinence cured      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
Percentage 37.0 45.8 0.383
Outcome: reoperation for SUI      Population: All Participants
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic


1 years

Mean
N Enrolled 141 144
Counts 5 6
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure TVT-Secur H vs. TVT-Secur U


1 days

N Analyzed 141 144 0.674
Mean 39.0 41.8
Standard Deviation 64.4 38.7
P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure TVT-Secur H vs. TVT-Secur U


0 days

N Analyzed 141 144 0.530
Mean 2.3 2.5
Standard Deviation 1.8 2.1
P-Value P-Value
Outcome: I-QOL avoidance/limiting behavior      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure TVT-Secur H vs. TVT-Secur U


1 years

N Analyzed 141 144 0.022
Mean 67.2 75.3


0 years

N Analyzed 141 144 n/a
Mean 41.8 41.8
Standard Deviation
P-Value P-Value
Outcome: I-QOL psychosocial impacts      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.021
Mean 67.7 76.0


0 years

N Analyzed 141 144 n/a
Mean 43.2 43.4
P-Value P-Value
Outcome: I-QOL social embarassment      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.015
Mean 70.0 79.6


0 years

N Analyzed 141 144 n/a
Mean 35.5 33.9
P-Value P-Value
Outcome: IVAS - incontinence visual analog scale      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.056
Mean 1.69 1.03


0 years

N Analyzed 141 144 n/a
Mean 6.75 6.9
P-Value P-Value
Outcome: voids per 24 hrs      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.218
Mean 7.92 8.02


0 years

N Analyzed 141 144 n/a
Mean 9.07 8.99
P-Value P-Value
Outcome: nocturia (# voids)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.615
Mean 0.69 0.68


0 years

N Analyzed 141 144 n/a
Mean 1.23 1.28
P-Value P-Value
Outcome: urgency episodes per 24 hrs      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.329
Mean 1.04 1.40


0 years

N Analyzed 141 144 n/a
Mean 1.86 2.88
P-Value
Outcome: uroflow Qmax      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 weeks

N Analyzed 141 144 0.576
Mean 23.7 25.0
P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 weeks

N Analyzed 141 144 0.306
Mean 20.6 19.6
P-Value P-Value
Outcome: ICIQ-FLUTS filling sum      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.022
Mean 4.04 3.18


0 years

N Analyzed 141 144 n/a
Mean 6.15 6.2
P-Value P-Value
Outcome: ICIQ-FLUTS voiding sum      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.276
Mean 1.61 1.86


0 years

N Analyzed 141 144 n/a
Mean 2.23 2.91
P-Value P-Value
Outcome: ICIQ-FLUTS sexual function score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.421
Mean 0.94 0.81


0 years

N Analyzed 141 144 n/a
Mean 1.66 1.81
P-Value P-Value
Outcome: ICIQ-FLUTS QOL score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.007
Mean 4.15 2.80


0 years

N Analyzed 141 144 n/a
Mean 7.64 7.90
P-Value P-Value
Outcome: ICIQ-FLUTS incontinence sum      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


0 years

N Analyzed 141 144 0.006
Mean 8.33 8.76


1 years

N Analyzed 141 144 n/a
Mean 4.12 2.82


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling obturator TVT secur H
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2 Minisling retropubic TVT secur U
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Name none
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Sling Category Minisling H (obturator)
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Minsling U (retropubic)
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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 ... Other ... reported as "funding: none"
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: Obj cure rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.091
Percentage 80.1 87.5
Counts 113 126
Statistical Test: P-Value
Outcome: Subj cure rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.786
Percentage 75.7 77.1
Counts 106 111
Statistical Test: P-Value
Outcome: Achieved goal for surgery      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.546
Percentage 78.2 83.8
Statistical Test: P-Value
Outcome: de novo urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.858
Percentage 7.6 7.0
Statistical Test: P-Value
Outcome: "would recommend to a friend"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144
Mean 85 90 0.026
Statistical Test: P-Value
Outcome: "satisfaction"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144
Mean 0.037
Percentage 77 87
Statistical Test: P-Value
Outcome: "would have this surgery again"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.002
Percentage 78 90
Statistical Test: P-Value
Outcome: perception of treatment benefit      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
N Enrolled 141 144 0.53
Percentage 75 85
Statistical Test: P-Value
Outcome: urgency incontinence cured      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

Mean
Percentage 37.0 45.8 0.383
Outcome: reoperation for SUI      Population: All Participants
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic


1 years

Mean
N Enrolled 141 144
Counts 5 6
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure TVT-Secur H vs. TVT-Secur U


1 days

N Analyzed 141 144 0.674
Mean 39.0 41.8
Standard Deviation 64.4 38.7
P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure TVT-Secur H vs. TVT-Secur U


0 days

N Analyzed 141 144 0.530
Mean 2.3 2.5
Standard Deviation 1.8 2.1
P-Value P-Value
Outcome: I-QOL avoidance/limiting behavior      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure TVT-Secur H vs. TVT-Secur U


1 years

N Analyzed 141 144 0.022
Mean 67.2 75.3


0 years

N Analyzed 141 144 n/a
Mean 41.8 41.8
Standard Deviation
P-Value P-Value
Outcome: I-QOL psychosocial impacts      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.021
Mean 67.7 76.0


0 years

N Analyzed 141 144 n/a
Mean 43.2 43.4
P-Value P-Value
Outcome: I-QOL social embarassment      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.015
Mean 70.0 79.6


0 years

N Analyzed 141 144 n/a
Mean 35.5 33.9
P-Value P-Value
Outcome: IVAS - incontinence visual analog scale      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.056
Mean 1.69 1.03


0 years

N Analyzed 141 144 n/a
Mean 6.75 6.9
P-Value P-Value
Outcome: voids per 24 hrs      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.218
Mean 7.92 8.02


0 years

N Analyzed 141 144 n/a
Mean 9.07 8.99
P-Value P-Value
Outcome: nocturia (# voids)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.615
Mean 0.69 0.68


0 years

N Analyzed 141 144 n/a
Mean 1.23 1.28
P-Value P-Value
Outcome: urgency episodes per 24 hrs      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.329
Mean 1.04 1.40


0 years

N Analyzed 141 144 n/a
Mean 1.86 2.88
P-Value
Outcome: uroflow Qmax      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 weeks

N Analyzed 141 144 0.576
Mean 23.7 25.0
P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 weeks

N Analyzed 141 144 0.306
Mean 20.6 19.6
P-Value P-Value
Outcome: ICIQ-FLUTS filling sum      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.022
Mean 4.04 3.18


0 years

N Analyzed 141 144 n/a
Mean 6.15 6.2
P-Value P-Value
Outcome: ICIQ-FLUTS voiding sum      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.276
Mean 1.61 1.86


0 years

N Analyzed 141 144 n/a
Mean 2.23 2.91
P-Value P-Value
Outcome: ICIQ-FLUTS sexual function score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.421
Mean 0.94 0.81


0 years

N Analyzed 141 144 n/a
Mean 1.66 1.81
P-Value P-Value
Outcome: ICIQ-FLUTS QOL score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed 141 144 0.007
Mean 4.15 2.80


0 years

N Analyzed 141 144 n/a
Mean 7.64 7.90
P-Value P-Value
Outcome: ICIQ-FLUTS incontinence sum      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-Secur U Minisling obturator Minisling retropubic Comparison Measure ERROR vs. ERROR


0 years

N Analyzed 141 144 0.006
Mean 8.33 8.76


1 years

N Analyzed 141 144 n/a
Mean 4.12 2.82

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 obturator Mesh erosion/extrusion/exposure/granulation tissue did not occur - no more detail available 12 mo 0 141
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Minisling retropubic 12 mo 0 144
Total 0
Minisling obturator de novo dyspareunia "no women complained of" 12 mo 0 141
  • Comments Comments (
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Minisling retropubic 12 mo 0 144
Total 0
Minisling obturator Transfusion post-op 12 mo in hospital 1 141
  • Comments Comments (
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Minisling retropubic 12 mo in hospital 0 144
Total 12 mo 1
Minisling obturator
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Minisling retropubic
Total
Minisling obturator Organ injury in OR (urethra, bladder, bowel) none reported 12 mo in hospital 0 141
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Minisling retropubic 12 mo in hospital 0 144
Total