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Study Title and Description

Use of slings made of indigenous and allogenic material (Goretex) in type III urinary incontinence and comparison between them.



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 Use of slings made of indigenous and allogenic material (Goretex) in type III urinary incontinence and comparison between them.
Author Barbalias G, Liatsikos E, Barbalias D
Country --
Year 1997
Numbers Pubmed ID: 9187896

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, Goretex Goretex Sling: 1.5 x 12cm sling, with "same approach as the fascial sling". Urethroscopy used to verify no protrusion of urethral lumen and to r/o urethral perforation. SPT filled to confirm no urethral defect.
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2 PVS, fascial Fascial Sling: LT incision, 1.5 cm above PS. 1.5x12cm, RF harvest. Median incision made in anterior vaginal wall, 2 vaginal mucosal flaps made to expose bladder neck and posterior urethra. "An opening was created" between to vaginal and RP spaces using sharp and blunt dissection. Care was taken not to angulate but just support the urethra. No mention of technique for securing the sling.
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Greece
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Outcome Categories Reported Subjective SUI
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Other (we expect this to rarely or never be chosen) ... urodynamic parameters
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Population (reason for surgery etc.) Symptomatic SUI
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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 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) C (poor)
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Overall Study Notes Few, if any, comparisons between groups.
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Study Sponsor/Funding ... Other ... unknown
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Baseline Characteristics
Question PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 16 32 48
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Mean Age 45 (median) comparable"
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Post-Op Follow-Up Interval (Maximum) at least 30 mo at least 30 mo
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Results & Comparisons


Results Data
P-Value P-Value
Outcome: SUI subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS Comparison Measure PVS, Goretex vs. PVS, fascial


0 months

N Enrolled 16 32
Counts 16 32
Standard Deviation


30 months

N Enrolled 16 32 <.05 favors fascial sling
Counts 14 26
Standard Deviation
Outcome: PVR      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


30 months

N Analyzed 16 32
Mean 38.2 82
Standard Deviation


0 months

N Analyzed 16 32
Mean 33.5 31
Standard Deviation
Outcome: Qmax      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


0 months

N Analyzed 16 32
Mean 11 11
Standard Deviation


30 months

N Analyzed 16 32
Mean 19 18
Standard Deviation
Outcome: functional length urethra      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


30 months

N Analyzed 16 32
Mean 2.3 2.4
Standard Deviation


0 months

N Analyzed 16 32
Mean 1.3 1.4
Standard Deviation
Outcome: max closure pressure      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


0 months

N Analyzed 16 32
Mean 42 43
Standard Deviation


30 months

N Analyzed 16 32
Mean 22 23
Standard Deviation
Outcome: first sensation      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


30 months

N Analyzed 16 32
Mean 175 180
Standard Deviation


0 months

N Analyzed 16 32
Mean 144 150
Standard Deviation
Outcome: Pdet max flow      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


30 months

N Analyzed 16 32
Mean 37 35
Standard Deviation


0 months

N Analyzed 16 32
Mean 33 30
Standard Deviation
Outcome: pdetmax      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


0 months

N Analyzed 16 32
Mean 37 38
Standard Deviation


30 months

N Analyzed 16 32
Mean 31 34
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Synthetic PVS Goretex
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2 Fascial PVS
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Greece
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Sling Category Pubovaginal (bladder neck)
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Multicenter? No
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures 1
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Surgeons' Training Urology
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Passive
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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 Industry
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Results & Comparisons


Results Data
P-Value P-Value
Outcome: SUI subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS Comparison Measure PVS, Goretex vs. PVS, fascial


0 months

N Enrolled 16 32
Counts 16 32
Standard Deviation


30 months

N Enrolled 16 32 <.05 favors fascial sling
Counts 14 26
Standard Deviation
Outcome: PVR      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


30 months

N Analyzed 16 32
Mean 38.2 82
Standard Deviation


0 months

N Analyzed 16 32
Mean 33.5 31
Standard Deviation
Outcome: Qmax      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


0 months

N Analyzed 16 32
Mean 11 11
Standard Deviation


30 months

N Analyzed 16 32
Mean 19 18
Standard Deviation
Outcome: functional length urethra      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


30 months

N Analyzed 16 32
Mean 2.3 2.4
Standard Deviation


0 months

N Analyzed 16 32
Mean 1.3 1.4
Standard Deviation
Outcome: max closure pressure      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


0 months

N Analyzed 16 32
Mean 42 43
Standard Deviation


30 months

N Analyzed 16 32
Mean 22 23
Standard Deviation
Outcome: first sensation      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


30 months

N Analyzed 16 32
Mean 175 180
Standard Deviation


0 months

N Analyzed 16 32
Mean 144 150
Standard Deviation
Outcome: Pdet max flow      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


30 months

N Analyzed 16 32
Mean 37 35
Standard Deviation


0 months

N Analyzed 16 32
Mean 33 30
Standard Deviation
Outcome: pdetmax      Population: All Participants
Time Point Measure PVS, Goretex PVS, fascial Synthetic PVS Fascial PVS


0 months

N Analyzed 16 32
Mean 37 38
Standard Deviation


30 months

N Analyzed 16 32
Mean 31 34
Standard Deviation

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
Synthetic PVS Mesh erosion/extrusion/exposure/granulation tissue urethral erosion 3.5 y after 2 16
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Fascial PVS not reported
Total
Synthetic PVS Infection, UTI 3 16
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Fascial PVS not reported
Total