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Study Title and Description

Comparative results of two techniques to treat stress urinary incontinence: synthetic transobturator and aponeurotic slings.



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 Comparative results of two techniques to treat stress urinary incontinence: synthetic transobturator and aponeurotic slings.
Author Tcherniakovsky M., Fernandes CE., Bezerra CA., Del Roy CA., Wroclawski ER.
Country ABC Medical School, Rua Dr. Albuquerque Lins 635/71, CEP: 01230-001 São Paulo, São Paulo, Brazil. marcosclinica@terra.com.br
Year 2009
Numbers Pubmed ID: 19582386
664 (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 Safyre-T Synthetic adjustable transobturator
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2 PVS, fascial Autologous rectus fascia
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Brazil
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Outcome Categories Reported Subjective SUI
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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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Recurrent incontinence after surgery
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RCT Comparison Category Pubovaginal sling vs. Other
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Other comparison ... Safyre-T (adjustable synthetic TOT) vs PVS
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures Not reported
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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) C (poor)
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Study Sponsor/Funding ... Other ... Unclear
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Baseline Characteristics
Question Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 21 20
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Mean Age 46.5 52.1
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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 Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


12 months

N Enrolled 21 20 1.00
Counts 19 19
P-Value
Outcome: "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


12 months

N Enrolled 21 20 1.00
Counts 0 0
P-Value
Outcome: "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


12 months

N Enrolled 21 20 1.00
Counts 2 1
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


0 months

N Analyzed 21 20 <0.0001
Mean 12.8 59.7
Standard Deviation 2.4 10.3
P-Value
Outcome: Postop PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


0 months

N Analyzed 21 20 >0.05
Mean 60 62.7
Standard Deviation 88.9 42.2


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Transobturator synthetic Safyre-T (adjustable)
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2 Fascial PVS Autologous rectus fascia
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Brazil
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Sling Category Obturator synthetic
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Pubovaginal (bladder neck)
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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: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


12 months

N Enrolled 21 20 1.00
Counts 19 19
P-Value
Outcome: "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


12 months

N Enrolled 21 20 1.00
Counts 0 0
P-Value
Outcome: "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


12 months

N Enrolled 21 20 1.00
Counts 2 1
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


0 months

N Analyzed 21 20 <0.0001
Mean 12.8 59.7
Standard Deviation 2.4 10.3
P-Value
Outcome: Postop PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-T PVS, fascial Transobturator synthetic Fascial PVS Comparison Measure Safyre-T vs. PVS, fascial


0 months

N Analyzed 21 20 >0.05
Mean 60 62.7
Standard Deviation 88.9 42.2

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
Transobturator synthetic Organ injury in OR (urethra, bladder, bowel) Bladder perforation Intra-op In-hospital ND ND 0 21 ND NS
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Fascial PVS Intra-op In-hospital ND ND 1 20 ND
Total
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue Vaginal <12mo After discharge ND ND 1 21 ND NS
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Fascial PVS <12mo After discharge ND ND 0 21 ND
Total
Transobturator synthetic Infection, UTI Unclear After discharge ND ND 0 21 ND NS
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Fascial PVS Unclear After discharge ND ND 2 20 ND
Total
Transobturator synthetic Infection, surgical site/wound Unclear After discharge ND ND 0 21 ND NS
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Fascial PVS Unclear After discharge ND ND 1 20 ND
Total
Transobturator synthetic Seroma/hematoma drainage Unclear After discharge ND ND 0 21 ND ND
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Fascial PVS Unclear After discharge ND ND 5 20 ND
Total
Transobturator synthetic fever Unclear In-hospital ND ND 0 21 ND NS
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Fascial PVS Unclear In-hospital ND ND 0 20 ND
Total
Transobturator synthetic Return to OR Wound dehiscence Unclear After discharge ND ND 0 21 ND ND
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Fascial PVS Unclear After discharge ND ND 1 20 ND
Total