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Study Title and Description

Tension-free vaginal tape and autologous rectus fascia pubovaginal sling for the treatment of urinary stress incontinence: a medium-term 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 Tension-free vaginal tape and autologous rectus fascia pubovaginal sling for the treatment of urinary stress incontinence: a medium-term follow-up.
Author Sharifiaghdas F, Mortazavi N
Country --
Year 2008
Numbers Pubmed ID: 18408389
14 (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 PVS, fascial
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Iran
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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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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Urodynamic SUI
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Other ... specifically type II USI (vLPP 60-90 cm H2O)
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RCT Comparison Category Retropubic vs. Other
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Other comparison ... autologous pubovaginal sling
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Multicenter No
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Institution Type Unclear/Not reported
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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? Unclear/Not reported
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Study Quality (overall) B (fair)
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Study Sponsor/Funding ... Other ... unclear but states "independent of any industry sponsorship or involvement"
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Baseline Characteristics
Question TVT PVS, fascial Retropubic synthetic Fascial PVS Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 100
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Mean Age 49.1 55
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Post-Op Follow-Up Interval (Maximum) 38.5 mo 40 mo
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Results & Comparisons


Results Data
P-Value
Outcome: EBL >250mL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Enrolled 25 36 1.00
Counts 1 1
Percentage 4 5
P-Value
Outcome: 1-hour pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


12 months

N Enrolled 25 36 0.83
Percentage 76 72
P-Value
Outcome: Negative cough stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


12 months

N Enrolled 25 36 0.9
Percentage 88 83
P-Value
Outcome: Patient Satisfaction composite      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


12 months

N Enrolled 25 36 0.3
Counts 15 20
Percentage 72 55
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Analyzed 25 36 0.01
Mean 45 80
Max 70 180
Min 30 50
P-Value
Outcome: Mean catheterization time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Analyzed 25 36 0.001
Mean 1.3 4.6
Max 5 6
Min 1 3
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Analyzed 25 36 0.001
Mean 2 5
Max 5 7
Min 1 3
P-Value
Outcome: IIQ      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


12 months

N Analyzed 25 36 0.46
Mean 44.3 48.5
Max 61.5 69.7
Min 35.2 38.5
P-Value
Outcome: Maximum Flow Rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Analyzed 25 36
Mean 31 30.2
Standard Error 12 10.8


12 months

N Analyzed 25 36 0.2
Mean 27 26.7
Standard Error 8.7 6.2


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
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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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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 ... Other ... Non-industry
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Not reported
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Results & Comparisons


Results Data
P-Value
Outcome: EBL >250mL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Enrolled 25 36 1.00
Counts 1 1
Percentage 4 5
P-Value
Outcome: 1-hour pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


12 months

N Enrolled 25 36 0.83
Percentage 76 72
P-Value
Outcome: Negative cough stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


12 months

N Enrolled 25 36 0.9
Percentage 88 83
P-Value
Outcome: Patient Satisfaction composite      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


12 months

N Enrolled 25 36 0.3
Counts 15 20
Percentage 72 55
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Analyzed 25 36 0.01
Mean 45 80
Max 70 180
Min 30 50
P-Value
Outcome: Mean catheterization time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Analyzed 25 36 0.001
Mean 1.3 4.6
Max 5 6
Min 1 3
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Analyzed 25 36 0.001
Mean 2 5
Max 5 7
Min 1 3
P-Value
Outcome: IIQ      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


12 months

N Analyzed 25 36 0.46
Mean 44.3 48.5
Max 61.5 69.7
Min 35.2 38.5
P-Value
Outcome: Maximum Flow Rate      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial Retropubic synthetic Fascial PVS Comparison Measure TVT vs. PVS, fascial


0 months

N Analyzed 25 36
Mean 31 30.2
Standard Error 12 10.8


12 months

N Analyzed 25 36 0.2
Mean 27 26.7
Standard Error 8.7 6.2

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
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bladder Intraop In-hospital ND ND 6 25 ND 0.05
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Fascial PVS Intraop In-hospital ND ND 2 36 ND
Total
Retropubic synthetic Retention PVR >100mL 6-12mo After discharge ND ND 1 25 ND 0.4
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Fascial PVS 6-12mo After discharge ND ND 5 36 ND
Total
Retropubic synthetic Retention requiring surgery 6-12mo After discharge ND ND 1 25 ND 1.00
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Fascial PVS 6-12mo After discharge ND ND 2 36 ND
Total
Retropubic synthetic De novo UUI self-reported >12mo After discharge ND ND 1 25 ND 0.1
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Fascial PVS >12mo After discharge ND ND 8 36 ND
Total
Retropubic synthetic Transfusion post-op Intraop Intraop In-hospital ND ND 1 25 ND NS
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Fascial PVS Intraop In-hospital ND ND 1 36 ND
Total
Retropubic synthetic Transfusion post-op Postop Peri-op In-hospital ND ND 0 25 ND NS
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Fascial PVS Peri-op In-hospital ND ND 0 36 ND
Total
Retropubic synthetic
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Fascial PVS
Total