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Study Title and Description

Prospective randomized trial comparing synthetic vs biological out-in transobturator tape: a mean 3-year follow-up study.



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 Prospective randomized trial comparing synthetic vs biological out-in transobturator tape: a mean 3-year follow-up study.
Author Paparella R., Marturano M., Pelino L., Scarpa A., Scambia G., La Torre G., Paparella P.
Country Association Columbus-Operative Unit, Urogynecology and Reconstructive Surgery of Pelvic Floor, Department for the Protection of the Health of Women and Rising Life, Catholic University of Sacred Heart, Via Giuseppe Moscati 31, 00168 Rome, Italy.
Year 2010
Numbers Pubmed ID: 20585757
9240 (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 biologic obturator pelvilace
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2 transobturator Uretex
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Italy
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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.) Symptomatic SUI
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Urodynamic SUI
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RCT Comparison Category Obturator 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 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) A (good)
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Overall Study Notes Single surgeon. Randomization seems adequate as it does the concealment of the allocation. Groups were balanced, so selection bias is less probable. Outcome assessment is not masked, however assessor is described as an independent surgeon. Adequately conducted study, with no concern for selection bias. Adequate length of follow up. Outcome assessment performed by an independent surgeon, but if is unclear if is blind or not. Primary outcome is an AE, not efficacy.
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Study Sponsor/Funding ... Other ... unclear
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Baseline Characteristics
Question biologic obturator transobturator Transobturator synthetic transobturator biologic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 36 34
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Mean Age 59 60
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Post-Op Follow-Up Interval (Maximum) 2 yrs 2 yrs 38 mos
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Results & Comparisons


Results Data
P-Value
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Enrolled 36 34 0.706
Counts 33 30
Percentage 88.8 88.2
P-Value
Outcome: subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Enrolled 36 34 0.913
Counts 30 28
Percentage 83.5 77.7
P-Value Statistical Test:
Outcome: Length of surgery      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


1 years

N Analyzed 36 34 0.174
Mean 10.8 10.4 Mann Whitney U
Standard Deviation 1.2 1.0
P-Value Statistical Test:
Outcome: Length of anesthesia      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


1 years

N Analyzed 36 34 0.07
Mean 31.6 30.7 Mann Whitney U
Standard Deviation 2.3 2.3
P-Value Statistical Test:
Outcome: Length of hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


1 years

N Analyzed 36 34 0.602
Mean 2.1 2.1 Mann Whitney U
Standard Deviation 0.4 0.3
P-Value Statistical Test:
Outcome: change in hemoglobin      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


1 years

N Analyzed 36 34 0.320
Mean 0.4 0.4 Mann Whitney U
Standard Deviation 0.2 0.2
P-Value Statistical Test:
Outcome: Postop pain VAS      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure transobturator vs. biologic obturator


1 years

N Analyzed 36 34 0.788
Mean 5.2 5.1 Mann Whitney U
Standard Deviation 0.8 0.7
P-Value Statistical Test:
Outcome: complication rate (overall)      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed NS
Mean 0 0
Standard Deviation 0 0
P-Value Statistical Test: P-Value Statistical Test:
Outcome: sex function      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 36 34 0.130
Mean 17.2 16.6 Mann Whitney U
Standard Deviation 3.0 3.0


0 years

N Analyzed 36 34 0.438
Mean 24.4 24 Mann Whitney U
Standard Deviation 2.4 2
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


0 years

N Analyzed 36 34 0.960
Mean 63.6 63.4 Mann Whitney U
Standard Deviation 22.1 20.4


2 years

N Analyzed 36 34 0.898
Mean 11.1 11.7 Mann Whitney U
Standard Deviation 24.2 25.5
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Analyzed 36 34 0.777
Mean 11.1 9.7 Mann Whitney U
Standard Deviation 31.8 25.3


0 years

N Analyzed 36 34 0.621
Mean 85.1 85.2 Mann Whitney U
Standard Deviation 23.1 16.8
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


0 years

N Analyzed 36 34 0.588
Mean 59.7 58.8 Mann Whitney U
Standard Deviation 28.0 21.4


2 years

N Analyzed 36 34 0.716
Mean 9.2 9.3 Mann Whitney U
Standard Deviation 26.8 24.6
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 36 34 0.966
Mean 10.1 10.2 Mann Whitney U
Standard Deviation 29.3 28.7


0 years

N Analyzed 36 34 0.834
Mean 62.0 62.2 Mann Whitney U
Standard Deviation 30.2 25.4
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure ERROR vs. ERROR


0 years

N Analyzed 36 34 0.719
Mean 61.0 61.7 Mann Whitney U
Standard Deviation 26.0 21.7


2 years

N Analyzed 36 34 0.966
Mean 8.6 7.8 Mann Whitney U
Standard Deviation 25.6 23.1
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Analyzed 36 34 0.932
Mean 11.1 8.8 Mann Whitney U
Standard Deviation 31.8 24.6


0 years

N Analyzed 36 34 0.637
Mean 72.1 72.0 Mann Whitney U
Standard Deviation 20.7 14.6
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


0 years

N Analyzed 36 34 0.990
Mean 73.7 74.6 Mann Whitney U
Standard Deviation 25.3 21.1


2 years

N Analyzed 36 34 0.966
Mean 11.1 10.2 Mann Whitney U
Standard Deviation 31.8 28.7
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Analyzed 36 34 0.932
Mean 7.8 8.3 Mann Whitney U
Standard Deviation 22.6 23.2


0 years

N Analyzed 36 34 0.724
Mean 70.7 70.5 Mann Whitney U
Standard Deviation 21.6 19.2
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


0 years

N Analyzed 36 34 0.561
Mean 72.1 72.5 Mann Whitney U
Standard Deviation 26.8 19.7


2 years

N Analyzed 36 34 0.983
Mean 10.1 9.4 Mann Whitney U
Standard Deviation 29.3 26.5
Outcome: SUI objective      Population: All Participants
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic


2 years

N Analyzed 36 34
Mean 33.4 32.8
Standard Deviation 12.8 12.6


0 years

N Analyzed 36 34
Mean 46.4 45.1
Standard Deviation 14.2 13.6


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Transobturator synthetic
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2 transobturator biologic
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Sling Category Obturator synthetic
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Obturator biologic
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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: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Enrolled 36 34 0.706
Counts 33 30
Percentage 88.8 88.2
P-Value
Outcome: subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Enrolled 36 34 0.913
Counts 30 28
Percentage 83.5 77.7
P-Value Statistical Test:
Outcome: Length of surgery      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


1 years

N Analyzed 36 34 0.174
Mean 10.8 10.4 Mann Whitney U
Standard Deviation 1.2 1.0
P-Value Statistical Test:
Outcome: Length of anesthesia      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


1 years

N Analyzed 36 34 0.07
Mean 31.6 30.7 Mann Whitney U
Standard Deviation 2.3 2.3
P-Value Statistical Test:
Outcome: Length of hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


1 years

N Analyzed 36 34 0.602
Mean 2.1 2.1 Mann Whitney U
Standard Deviation 0.4 0.3
P-Value Statistical Test:
Outcome: change in hemoglobin      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


1 years

N Analyzed 36 34 0.320
Mean 0.4 0.4 Mann Whitney U
Standard Deviation 0.2 0.2
P-Value Statistical Test:
Outcome: Postop pain VAS      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure transobturator vs. biologic obturator


1 years

N Analyzed 36 34 0.788
Mean 5.2 5.1 Mann Whitney U
Standard Deviation 0.8 0.7
P-Value Statistical Test:
Outcome: complication rate (overall)      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure ERROR vs. ERROR


1 years

N Analyzed NS
Mean 0 0
Standard Deviation 0 0
P-Value Statistical Test: P-Value Statistical Test:
Outcome: sex function      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 36 34 0.130
Mean 17.2 16.6 Mann Whitney U
Standard Deviation 3.0 3.0


0 years

N Analyzed 36 34 0.438
Mean 24.4 24 Mann Whitney U
Standard Deviation 2.4 2
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


0 years

N Analyzed 36 34 0.960
Mean 63.6 63.4 Mann Whitney U
Standard Deviation 22.1 20.4


2 years

N Analyzed 36 34 0.898
Mean 11.1 11.7 Mann Whitney U
Standard Deviation 24.2 25.5
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Analyzed 36 34 0.777
Mean 11.1 9.7 Mann Whitney U
Standard Deviation 31.8 25.3


0 years

N Analyzed 36 34 0.621
Mean 85.1 85.2 Mann Whitney U
Standard Deviation 23.1 16.8
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


0 years

N Analyzed 36 34 0.588
Mean 59.7 58.8 Mann Whitney U
Standard Deviation 28.0 21.4


2 years

N Analyzed 36 34 0.716
Mean 9.2 9.3 Mann Whitney U
Standard Deviation 26.8 24.6
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure ERROR vs. ERROR


2 years

N Analyzed 36 34 0.966
Mean 10.1 10.2 Mann Whitney U
Standard Deviation 29.3 28.7


0 years

N Analyzed 36 34 0.834
Mean 62.0 62.2 Mann Whitney U
Standard Deviation 30.2 25.4
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure ERROR vs. ERROR


0 years

N Analyzed 36 34 0.719
Mean 61.0 61.7 Mann Whitney U
Standard Deviation 26.0 21.7


2 years

N Analyzed 36 34 0.966
Mean 8.6 7.8 Mann Whitney U
Standard Deviation 25.6 23.1
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Analyzed 36 34 0.932
Mean 11.1 8.8 Mann Whitney U
Standard Deviation 31.8 24.6


0 years

N Analyzed 36 34 0.637
Mean 72.1 72.0 Mann Whitney U
Standard Deviation 20.7 14.6
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


0 years

N Analyzed 36 34 0.990
Mean 73.7 74.6 Mann Whitney U
Standard Deviation 25.3 21.1


2 years

N Analyzed 36 34 0.966
Mean 11.1 10.2 Mann Whitney U
Standard Deviation 31.8 28.7
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


2 years

N Analyzed 36 34 0.932
Mean 7.8 8.3 Mann Whitney U
Standard Deviation 22.6 23.2


0 years

N Analyzed 36 34 0.724
Mean 70.7 70.5 Mann Whitney U
Standard Deviation 21.6 19.2
P-Value Statistical Test: P-Value Statistical Test:
Outcome: QOL      Population: All Participants Between-Arm Comparisons
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic Comparison Measure biologic obturator vs. transobturator


0 years

N Analyzed 36 34 0.561
Mean 72.1 72.5 Mann Whitney U
Standard Deviation 26.8 19.7


2 years

N Analyzed 36 34 0.983
Mean 10.1 9.4 Mann Whitney U
Standard Deviation 29.3 26.5
Outcome: SUI objective      Population: All Participants
Time Point Measure biologic obturator transobturator Transobturator synthetic transobturator biologic


2 years

N Analyzed 36 34
Mean 33.4 32.8
Standard Deviation 12.8 12.6


0 years

N Analyzed 36 34
Mean 46.4 45.1
Standard Deviation 14.2 13.6

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 Infection, UTI 2 yrs after 0 ns
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transobturator biologic 2 yrs after 0 ns
Total
Transobturator synthetic
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transobturator biologic
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