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Study Title and Description

Cadaveric fascia lata versus intravaginal slingplasty for the pubovaginal sling: surgical outcome, overall success and patient satisfaction rates



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 Cadaveric fascia lata versus intravaginal slingplasty for the pubovaginal sling: surgical outcome, overall success and patient satisfaction rates
Author Basok EK, Yildirim A, Atsu N, Basaran A, Tokuc R
Country --
Year 2008
Numbers Pubmed ID: 18204233
3005 (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 PVS, fascial Cadaveric fascia lata
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2 IVS
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Turkey
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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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Mixed incontinence
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RCT Comparison Category Pubovaginal sling 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 Not reported
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Surgeons' Training Urology
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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 Industry
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Baseline Characteristics
Question PVS, fascial IVS Fascial PVS IVS Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 67 72
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Mean Age 47.4 50.3
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Post-Op Follow-Up Interval (Maximum) 12 mo 12 mo
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Results & Comparisons


Results Data
Outcome: "Cure"      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


12 months

 Percentage 52.2 47.2
Outcome: "Improvement"      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


12 months

 Percentage 26.8 23.6
Outcome: "Total Success Rate"      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


12 months

 Percentage 79.0 70.8
Outcome: Satisfaction      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


12 months

 Percentage 82.0 87.5
Outcome: OR time      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


0 N/A

 N Analyzed 67 72
Mean 50 25


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Fascial PVS Cadaveric fascia lata
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2 IVS
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Sling Category Pubovaginal (bladder neck)
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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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Results & Comparisons


Results Data
Outcome: "Cure"      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


12 months

 Percentage 52.2 47.2
Outcome: "Improvement"      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


12 months

 Percentage 26.8 23.6
Outcome: "Total Success Rate"      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


12 months

 Percentage 79.0 70.8
Outcome: Satisfaction      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


12 months

 Percentage 82.0 87.5
Outcome: OR time      Population: All Participants
Time Point Measure PVS, fascial IVS Fascial PVS IVS


0 N/A

 N Analyzed 67 72
Mean 50 25

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
Fascial PVS Organ injury in OR (urethra, bladder, bowel) Bladder perforation Intraop In-hospital ND ND 3 67 ND 0.147
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IVS Intraop In-hospital ND ND 8 72
Total
Fascial PVS Hematoma "Late" After discharge ND ND 0 67 ND NS
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IVS "Late" After discharge ND ND 0 72
Total
Fascial PVS Defective vaginal healing "Late" After discharge ND ND 0 67 ND NS
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IVS "Late" After discharge ND ND 0 72
Total
Fascial PVS Mesh erosion/extrusion/exposure/granulation tissue "Late" After discharge ND ND 0 67 ND NS
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IVS "Late" After discharge ND ND 0 72
Total
Fascial PVS Urinary retention Catheterization up to a month >1mo After discharge ND ND 8 67 ND 0.878
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IVS >1mo After discharge ND ND 8 72
Total
Fascial PVS Retention requiring surgery Release of fascial sling sutures >1mo After discharge Yes ND 2 67 ND 1.0
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IVS >1mo After discharge Yes ND 0 72
Total
Fascial PVS De novo UUI ND After discharge ND ND 15 67 ND 0.009
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IVS ND After discharge ND ND 5 72
Total
Fascial PVS Persistent UUI ND After discharge ND ND 37 67 ND 0.0001
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IVS ND After discharge ND ND 18 72
Total