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Study Title and Description

Clinical and quality-of-life outcomes after autologous fascial sling and tension-free vaginal tape: a 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 Clinical and quality-of-life outcomes after autologous fascial sling and tension-free vaginal tape: a prospective randomized trial.
Author Amaro JL., Yamamoto H., Kawano PR., Barros G., Gameiro MO., Agostinho AD.
Country Department of Urology, School of Medicine, UNESP, Botucatu, Sao Paulo, Brazil. jamaro@fmb.unesp.br
Year 2009
Numbers Pubmed ID: 19254400
22 (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 autologous rectus fascia
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2 TVT
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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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Quality of life
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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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Recurrent incontinence after surgery
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RCT Comparison Category Pubovaginal sling vs. Other
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Other comparison ... TVT
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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 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 ... not reported
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Baseline Characteristics
Question PVS, fascial TVT Fascial PVS Retropubic synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 21 20
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Mean Age 49 52
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Post-Op Follow-Up Interval (Maximum) 44 mo (median)
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Results & Comparisons


Results Data
P-Value
Outcome: 12mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


12 months

N Enrolled 21 20 >0.05
Percentage 57 65
P-Value
Outcome: 36mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Enrolled 21 20 >0.05
Percentage 55 63
P-Value
Outcome: Patient satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Enrolled 21 20 >0.05
Percentage 80 58
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 <0.05
Mean 70 33
Max 105 70
Min 45 25
P-Value
Outcome: Mean dosage of analgesics      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 >0.05
Mean 142 85
Max 473 269
Min 50 15
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 >0.05
Mean 24 24
Max 48 48
Min 24 24
P-Value
Outcome: Duration postop catheterizations      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 >0.05
Mean 24 24
Max 48 72
Min 12 12
P-Value
Outcome: Days until return to normal activities      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 >0.05
Mean 30 30
Max 90 90
Min 3 4
P-Value
Outcome: KHQ - general health      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 50 50
Max 100 75
Min 0 0
P-Value
Outcome: KHQ - incontinence impact      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 33.34 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - role limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 0 0
Max 83.33 100
Min 0 0
P-Value
Outcome: KHQ - physical limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 0 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - social limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 5.56 0
Max 100 66.67
Min 0 0
P-Value
Outcome: KHQ - personal relationships      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 0 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - emotions      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 0 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - sleep      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 25 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - severity perception of UI      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 16.67 26.57
Max 86.67 100
Min 0 0


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Fascial PVS
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2 Retropubic 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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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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Study Sponsor/Funding Not reported
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Results & Comparisons


Results Data
P-Value
Outcome: 12mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


12 months

N Enrolled 21 20 >0.05
Percentage 57 65
P-Value
Outcome: 36mo "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Enrolled 21 20 >0.05
Percentage 55 63
P-Value
Outcome: Patient satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Enrolled 21 20 >0.05
Percentage 80 58
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 <0.05
Mean 70 33
Max 105 70
Min 45 25
P-Value
Outcome: Mean dosage of analgesics      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 >0.05
Mean 142 85
Max 473 269
Min 50 15
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 >0.05
Mean 24 24
Max 48 48
Min 24 24
P-Value
Outcome: Duration postop catheterizations      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 >0.05
Mean 24 24
Max 48 72
Min 12 12
P-Value
Outcome: Days until return to normal activities      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


0 months

N Analyzed 21 20 >0.05
Mean 30 30
Max 90 90
Min 3 4
P-Value
Outcome: KHQ - general health      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 50 50
Max 100 75
Min 0 0
P-Value
Outcome: KHQ - incontinence impact      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 33.34 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - role limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 0 0
Max 83.33 100
Min 0 0
P-Value
Outcome: KHQ - physical limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 0 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - social limitations      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 5.56 0
Max 100 66.67
Min 0 0
P-Value
Outcome: KHQ - personal relationships      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 0 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - emotions      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 0 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - sleep      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 25 0
Max 100 100
Min 0 0
P-Value
Outcome: KHQ - severity perception of UI      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, fascial TVT Fascial PVS Retropubic synthetic Comparison Measure PVS, fascial vs. TVT


36 months

N Analyzed 21 20 >0.05
Median 16.67 26.57
Max 86.67 100
Min 0 0

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 Intraop In-hospital ND ND 1 21 ND >0.05
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Retropubic synthetic Intraop In-hospital ND ND 2 20 ND
Total
Fascial PVS De novo urgency not defined 36mo After discharge ND ND 8 21 ND >0.05
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Retropubic synthetic 36mo After discharge ND ND 9 20 ND
Total