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Study Title and Description

TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized 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 TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial.
Author Krofta L., Feyereisl J., Otcenásek M., Velebil P., Kasíková E., Krcmár M.
Country Institute for the Care of Mother and Child, Podolske nabrezi 157, 147 00, Prague 4, Czech Republic. ladislav.krofta@post.cz
Year 2010
Numbers Pubmed ID: 19907913
800 (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-O
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Czech Republic
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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.) Urodynamic SUI
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Mixed incontinence
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RCT Comparison Category Retropubic vs. Obturator
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Multicenter No
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Institution Type Unclear/Not reported
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Number of surgeons performing procedures ... Other ... 3
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Surgeons' Training Urogynecology
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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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Study Sponsor/Funding ... Other ... Unclear
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Baseline Characteristics
Question TVT TVT-O Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 149 151
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Mean Age 57.19 57.82
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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: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 127 130
Percentage 90.1 88.4
P-Value
Outcome: "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 12 14
Percentage 8.5 9.5
P-Value
Outcome: "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 2 3
Percentage 1.4 2.0
P-Value
Outcome: Subjective Cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 111 112
Percentage 78.7 76.2
P-Value
Outcome: Subjective Improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 27 31
Percentage 19.1 21.1
P-Value
Outcome: Subjective failure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 3 4
Percentage 2.1 2.7
P-Value
Outcome: Overall Satisfaction: satisfied or very satisfied      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 141 145
Percentage 100 98.6
P-Value P-Value
Outcome: Incontinence Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 7.86 7.91
Standard Deviation 1.61 1.82


12 months

N Analyzed 141 147 NS
Mean 2.14 2.16
Standard Deviation 1.45 1.88
P-Value
Outcome: CONTILIFE-Daily activities      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Mean 10.32 10.62
Standard Deviation 5.14 4.21
P-Value P-Value
Outcome: ICIQ      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 13.28 13.76
Standard Deviation 15.83 4.78


12 months

N Analyzed 141 147 NS
Mean 3.00 3.5
Standard Deviation 4.92 3.47
P-Value
Outcome: CONTILIFE-Sexuality      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Mean 5.57 5.07
Standard Deviation 1.37 1.97
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 <0.001
Mean 32.62 23.76
Standard Deviation 9.3 12.01
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 31.57 32.26
Standard Deviation 31.92 34.80
P-Value
Outcome: Hemoglobin      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 130.93 132.27
Standard Deviation 10.18 10.92
P-Value P-Value
Outcome: Maximum flow rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 34.02 35.28
Standard Deviation 19.27 29.45


12 months

N Analyzed 141 147 NS
Mean 23.85 24.57
Standard Deviation 7.39 12.96


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
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2 Transobturator synthetic
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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 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: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 127 130
Percentage 90.1 88.4
P-Value
Outcome: "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 12 14
Percentage 8.5 9.5
P-Value
Outcome: "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 2 3
Percentage 1.4 2.0
P-Value
Outcome: Subjective Cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 111 112
Percentage 78.7 76.2
P-Value
Outcome: Subjective Improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 27 31
Percentage 19.1 21.1
P-Value
Outcome: Subjective failure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 3 4
Percentage 2.1 2.7
P-Value
Outcome: Overall Satisfaction: satisfied or very satisfied      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Counts 141 145
Percentage 100 98.6
P-Value P-Value
Outcome: Incontinence Severity      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 7.86 7.91
Standard Deviation 1.61 1.82


12 months

N Analyzed 141 147 NS
Mean 2.14 2.16
Standard Deviation 1.45 1.88
P-Value
Outcome: CONTILIFE-Daily activities      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Mean 10.32 10.62
Standard Deviation 5.14 4.21
P-Value P-Value
Outcome: ICIQ      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 13.28 13.76
Standard Deviation 15.83 4.78


12 months

N Analyzed 141 147 NS
Mean 3.00 3.5
Standard Deviation 4.92 3.47
P-Value
Outcome: CONTILIFE-Sexuality      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


12 months

N Analyzed 141 147 NS
Mean 5.57 5.07
Standard Deviation 1.37 1.97
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 <0.001
Mean 32.62 23.76
Standard Deviation 9.3 12.01
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 31.57 32.26
Standard Deviation 31.92 34.80
P-Value
Outcome: Hemoglobin      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 130.93 132.27
Standard Deviation 10.18 10.92
P-Value P-Value
Outcome: Maximum flow rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TVT-O


0 months

N Analyzed 149 151 NS
Mean 34.02 35.28
Standard Deviation 19.27 29.45


12 months

N Analyzed 141 147 NS
Mean 23.85 24.57
Standard Deviation 7.39 12.96

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 Organ injury in OR (urethra, bladder, bowel) Bladder injury Intraop In-hospital No ND 1 149 ND NS
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Transobturator synthetic Intraop In-hospital No ND 0 151 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Uretheral injury Intraop In-hospital No ND 0 149 ND NA
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Transobturator synthetic Intraop In-hospital No ND 0 151 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Vaginal wall perforation Intraop In-hospital No ND 0 149 ND NA
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Transobturator synthetic Intraop In-hospital No ND 0 151 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bowel injury Intraop In-hospital No ND 0 149 ND NA
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Transobturator synthetic Intraop In-hospital No ND 0 151 ND
Total
Retropubic synthetic Retention >100mL at 24h 24hr In-hospital No ND 4 149 ND NS
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Transobturator synthetic 24hr In-hospital No ND 10 151 ND
Total
Retropubic synthetic Hematoma 2d In-hospital No ND 1 149 ND NS
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Transobturator synthetic 2d In-hospital No ND 0 151 ND
Total
Retropubic synthetic Infection, UTI Periop After discharge No ND 5 149 ND NS
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Transobturator synthetic Periop After discharge No ND 8 151 ND
Total
Retropubic synthetic Retention requiring surgery "Slings needing release" Periop After discharge ND ND 1 149 ND NS
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Transobturator synthetic Periop After discharge ND ND 1 151 ND
Total
Retropubic synthetic Pain, groin (new or different after surgery) Inner thigh Periop After discharge ND ND 0 149 ND NS
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Transobturator synthetic Periop After discharge ND ND 8 151 ND
Total
Retropubic synthetic Pain, other (new or different after surgery) Suprapubic discomfort Periop After discharge ND ND 6 149 ND NS
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Transobturator synthetic Periop After discharge ND ND 0 151 ND
Total