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Study Title and Description

Randomized Comparative Study of the U- and H-Type Approaches of the TVT-Secur Procedure for the Treatment of Female Stress Urinary Incontinence: One-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 Randomized Comparative Study of the U- and H-Type Approaches of the TVT-Secur Procedure for the Treatment of Female Stress Urinary Incontinence: One-Year Follow-Up.
Author Kim JJ., Lee YS., Lee KS.
Country Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Year 2010
Numbers Pubmed ID: 20428427
1424 (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-Secur U
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2 TVT-Secur H
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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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Quality of life
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Urodynamic SUI
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Intrinsic sphincter deficiency
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RCT Comparison Category Minisling vs. Other
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures 1
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Surgeons' Training Urology
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Residents or fellows performing surgery? No
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Study Quality (overall) B (fair)
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Study Sponsor/Funding ... Other ... Unclear
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Baseline Characteristics
Question TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 53 62
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Mean Age 55.21 56.6
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Post-Op Follow-Up Interval (Maximum) 12 mo 12 mo
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Results & Comparisons


Results Data
P-Value
Outcome: Satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 82.9 84.3 0.858
P-Value
Outcome: Perceived surgery was benefit      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 80.5 86.3 0.455
P-Value
Outcome: Recommend to a friend      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 87.8 88.0 0.442
P-Value
Outcome: Would undergo same surgery again      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 87.8 86.3 0.800
P-Value
Outcome: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 88.7 87.1 0.796
N Analyzed 53 62
Counts 47 54
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.114
Mean 14.77 13.42
Standard Deviation 6.35 5.13
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.645
Mean 56.45 66.36
Standard Deviation 45.31 71.63
P-Value
Outcome: Immediate Postop Pain VAS      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.926
Mean 2.18 2.09
Standard Deviation 2.00 1.77
P-Value P-Value
Outcome: I-QoL - Total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 39.32 43.04
Standard Deviation 21.32 22.38


12 months

N Analyzed 53 62 0.6070
Mean 70.56 71.89
Standard Deviation 16.43 18.42
P-Value P-Value
Outcome: I-QoL - Avoidance and limiting behavior      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 44.42 75.63
Standard Deviation 22.72 18.44


12 months

N Analyzed 53 62 0.7551
Mean 75.63 78.52
Standard Deviation 18.44 19.31
P-Value P-Value
Outcome: I-QoL - Psychosocial impacts      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 46.34 50.04
Standard Deviation 26.08 27.44


12 months

N Analyzed 53 62 0.4139
Mean 77.88 78.01
Standard Deviation 17.12 20.66
P-Value P-Value
Outcome: I-QoL - Social embarrassment      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 36.04 39.92
Standard Deviation 26.01 28.29


12 months

N Analyzed 53 62 0.7216
Mean 82.35 84.00
Standard Deviation 22.70 23.65
P-Value P-Value
Outcome: BLUFTS - filling symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 4.87 5.08
Standard Deviation 2.63 2.72


12 months

N Analyzed 53 62 0.4693
Mean 2.80 2.97
Standard Deviation 1.95 2.37
P-Value P-Value
Outcome: BLUFTS - voiding symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 1.75 1.81
Standard Deviation 2.66 2.28


12 months

N Analyzed 53 62 0.1733
Mean 1.84 1.36
Standard Deviation 2.64 1.94
P-Value P-Value
Outcome: BLUFTS - incontinence symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 9.00 7.66
Standard Deviation 3.72 3.87


12 months

N Analyzed 53 62 0.0210
Mean 1.60 2.47
Standard Deviation 2.42 3.28
P-Value P-Value
Outcome: BLUFTS - sexual function      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 1.30 1.08
Standard Deviation 1.54 1.41


12 months

N Analyzed 53 62 0.3822
Mean 0.20 0.42
Standard Deviation 0.45 1.12
P-Value P-Value
Outcome: BLUFTS - QoL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 7.87 6.89
Standard Deviation 4.55 4.22


12 months

N Analyzed 53 62 0.2857
Mean 1.98 2.15
Standard Deviation 3.31 3.32
P-Value P-Value
Outcome: Max Flow (Qmax)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 22.65 25.05
Standard Deviation 7.49 11.20


12 months

N Analyzed 53 62 0.2048
Mean 17.74 22.14
Standard Deviation 9.12 10.42
P-Value P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 15.19 19.80
Standard Deviation 19.89 29.99


12 months

N Analyzed 53 62 0.3035
Mean 24.00 40.29
Standard Deviation 23.35 46.04
P-Value P-Value
Outcome: Diary - Nocturia      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 0.72 0.80
Standard Deviation 0.82 0.81


12 months

N Analyzed 53 62 0.1740
Mean 0.98 0.78
Standard Deviation 0.97 0.73
P-Value P-Value
Outcome: Diary - Urgency episodes      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 2.54 2.79
Standard Deviation 3.25 3.74


12 months

N Analyzed 53 62 0.3234
Mean 2.42 1.55
Standard Deviation 3.24 2.23
P-Value P-Value
Outcome: Diary - Urgency scale      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 2.07 211
Standard Deviation 1.00 0.98


12 months

N Analyzed 53 62 0.8817
Mean 1.85 1.89
Standard Deviation 1.18 0.96
P-Value P-Value
Outcome: Incontinence VAS (I-VAS)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 6.61 6.69
Standard Deviation 2.15 2.14


12 months

N Analyzed 53 62 0.4354
Mean 0.95 1.20
Standard Deviation 2.41 2.31
P-Value
Outcome: Time til return to house work      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.624
Mean 7.18 5.43
Standard Deviation 12.15 9.89
P-Value
Outcome: Time til return to job      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.207
Mean 9.33 6.64
Standard Deviation 9.69 8.27
P-Value
Outcome: Time til return to social activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.347
Mean 14.33 11.41
Standard Deviation 20.31 17.17
P-Value
Outcome: Time til return to hobby      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.442
Mean 14.84 11.08
Standard Deviation 15.11 12.67
P-Value
Outcome: Time til return to sexual activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.885
Mean 38.96 39.56
Standard Deviation 15.31 14.20


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling retropubic TVT-Secure U
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2 Minisling obturator TVT-Secure H
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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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 Not reported
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Results & Comparisons


Results Data
P-Value
Outcome: Satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 82.9 84.3 0.858
P-Value
Outcome: Perceived surgery was benefit      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 80.5 86.3 0.455
P-Value
Outcome: Recommend to a friend      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 87.8 88.0 0.442
P-Value
Outcome: Would undergo same surgery again      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 87.8 86.3 0.800
P-Value
Outcome: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


12 months

Percentage 88.7 87.1 0.796
N Analyzed 53 62
Counts 47 54
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.114
Mean 14.77 13.42
Standard Deviation 6.35 5.13
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.645
Mean 56.45 66.36
Standard Deviation 45.31 71.63
P-Value
Outcome: Immediate Postop Pain VAS      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.926
Mean 2.18 2.09
Standard Deviation 2.00 1.77
P-Value P-Value
Outcome: I-QoL - Total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 39.32 43.04
Standard Deviation 21.32 22.38


12 months

N Analyzed 53 62 0.6070
Mean 70.56 71.89
Standard Deviation 16.43 18.42
P-Value P-Value
Outcome: I-QoL - Avoidance and limiting behavior      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 44.42 75.63
Standard Deviation 22.72 18.44


12 months

N Analyzed 53 62 0.7551
Mean 75.63 78.52
Standard Deviation 18.44 19.31
P-Value P-Value
Outcome: I-QoL - Psychosocial impacts      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 46.34 50.04
Standard Deviation 26.08 27.44


12 months

N Analyzed 53 62 0.4139
Mean 77.88 78.01
Standard Deviation 17.12 20.66
P-Value P-Value
Outcome: I-QoL - Social embarrassment      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 36.04 39.92
Standard Deviation 26.01 28.29


12 months

N Analyzed 53 62 0.7216
Mean 82.35 84.00
Standard Deviation 22.70 23.65
P-Value P-Value
Outcome: BLUFTS - filling symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 4.87 5.08
Standard Deviation 2.63 2.72


12 months

N Analyzed 53 62 0.4693
Mean 2.80 2.97
Standard Deviation 1.95 2.37
P-Value P-Value
Outcome: BLUFTS - voiding symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 1.75 1.81
Standard Deviation 2.66 2.28


12 months

N Analyzed 53 62 0.1733
Mean 1.84 1.36
Standard Deviation 2.64 1.94
P-Value P-Value
Outcome: BLUFTS - incontinence symptoms      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 9.00 7.66
Standard Deviation 3.72 3.87


12 months

N Analyzed 53 62 0.0210
Mean 1.60 2.47
Standard Deviation 2.42 3.28
P-Value P-Value
Outcome: BLUFTS - sexual function      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 1.30 1.08
Standard Deviation 1.54 1.41


12 months

N Analyzed 53 62 0.3822
Mean 0.20 0.42
Standard Deviation 0.45 1.12
P-Value P-Value
Outcome: BLUFTS - QoL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 7.87 6.89
Standard Deviation 4.55 4.22


12 months

N Analyzed 53 62 0.2857
Mean 1.98 2.15
Standard Deviation 3.31 3.32
P-Value P-Value
Outcome: Max Flow (Qmax)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 22.65 25.05
Standard Deviation 7.49 11.20


12 months

N Analyzed 53 62 0.2048
Mean 17.74 22.14
Standard Deviation 9.12 10.42
P-Value P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 15.19 19.80
Standard Deviation 19.89 29.99


12 months

N Analyzed 53 62 0.3035
Mean 24.00 40.29
Standard Deviation 23.35 46.04
P-Value P-Value
Outcome: Diary - Nocturia      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 0.72 0.80
Standard Deviation 0.82 0.81


12 months

N Analyzed 53 62 0.1740
Mean 0.98 0.78
Standard Deviation 0.97 0.73
P-Value P-Value
Outcome: Diary - Urgency episodes      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 2.54 2.79
Standard Deviation 3.25 3.74


12 months

N Analyzed 53 62 0.3234
Mean 2.42 1.55
Standard Deviation 3.24 2.23
P-Value P-Value
Outcome: Diary - Urgency scale      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 2.07 211
Standard Deviation 1.00 0.98


12 months

N Analyzed 53 62 0.8817
Mean 1.85 1.89
Standard Deviation 1.18 0.96
P-Value P-Value
Outcome: Incontinence VAS (I-VAS)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 ND
Mean 6.61 6.69
Standard Deviation 2.15 2.14


12 months

N Analyzed 53 62 0.4354
Mean 0.95 1.20
Standard Deviation 2.41 2.31
P-Value
Outcome: Time til return to house work      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.624
Mean 7.18 5.43
Standard Deviation 12.15 9.89
P-Value
Outcome: Time til return to job      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.207
Mean 9.33 6.64
Standard Deviation 9.69 8.27
P-Value
Outcome: Time til return to social activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.347
Mean 14.33 11.41
Standard Deviation 20.31 17.17
P-Value
Outcome: Time til return to hobby      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.442
Mean 14.84 11.08
Standard Deviation 15.11 12.67
P-Value
Outcome: Time til return to sexual activity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur U TVT-Secur H Minisling retropubic Minisling obturator Comparison Measure TVT-Secur U vs. TVT-Secur H


0 months

N Analyzed 53 62 0.885
Mean 38.96 39.56
Standard Deviation 15.31 14.20

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 dyspareunia or lost libido Unclear After discharge ND ND 0 53 ND ND
  • Comments Comments (
    0
    ) |
Minisling obturator 0 62
Total
Minisling retropubic Organ injury in OR (urethra, bladder, bowel) Vaginal wall perforation Intraop In-hospital ND ND 0 53 ND ND
  • Comments Comments (
    0
    ) |
Minisling obturator 3 62
Total
Minisling retropubic Immed postop retention Periop In-hospital ND ND 2 53 ND ND
  • Comments Comments (
    0
    ) |
Minisling obturator 1 62
Total
Minisling retropubic Return to OR Persistent urine leakage necessitating additional sling surgery - not defined by arm <12mo After discharge ND ND ND 53 ND ND
  • Comments Comments (
    0
    ) |
Minisling obturator ND 62
Total 4 115
Minisling retropubic Obstruction requiring reoperation <12mo After discharge ND ND ND 53 ND ND
  • Comments Comments (
    0
    ) |
Minisling obturator ND 62
Total 1 115