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Study Title and Description

Comparison of Burch and lyodura sling procedures for repair of unsuccessful incontinence surgery.



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 Comparison of Burch and lyodura sling procedures for repair of unsuccessful incontinence surgery.
Author Enzelsberger H, Helmer H, Schatten C
Country --
Year 1996
Numbers Pubmed ID: 8692511
RefID# 2942 (pubmed)

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 Lyodura sling
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2 Burch
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Austria
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Outcome Categories Reported Objective SUI
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Subjective SUI
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Recurrent incontinence after surgery
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Other ... The prior anti incontinence surgery was anterior repair
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RCT Comparison Category Sling vs. Burch
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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 Urogynecology
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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 The study was not well presented: difficult to tell when randomization occurred; also even/odd assignments not valid randomization scheme; single surgeon experience; focus on UDS parameters despite lack of difference in SUI outcome; small sample size
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Study Sponsor/Funding ... Other ... unknown
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Baseline Characteristics
Question Lyodura sling Burch Lyodura sling Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 36 36
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Mean Age 56.3 59.8
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Post-Op Follow-Up Interval (Maximum) 37 mo (mean) 35 mo (mean)
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Results & Comparisons


Results Data
Outcome: SUI objective      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean not listed not listed
Standard Deviation


3 years

N Analyzed 33 31
Mean not listed not listed
Standard Deviation
Outcome: SUI subjective      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


3 years

N Analyzed not listed not listed
Mean
Standard Deviation


0 years

N Analyzed not listed not listed
Mean
Standard Deviation
Outcome: UUI objective      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean 0 0
Standard Deviation


3 years

N Analyzed 36 36
Mean 3 (#) 1 (#)
Standard Deviation
Outcome: UUI subjective      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


3 years

N Analyzed 36 36
Mean not listed not listed
Standard Deviation


0 years

N Analyzed 36 36
Mean not listed not listed
Standard Deviation
Outcome: de novo UUI      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean 1 (#) 1(#)
Standard Deviation


3 years

N Analyzed 36 36
Mean 6(#) 3(#)
Standard Deviation
Outcome: ISD patients (if applic)      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


3.5 years

N Analyzed 36 36
Mean 38 40
Standard Deviation 11 12


0 years

N Analyzed 36 36
Mean 40 50
Standard Deviation 13 10
Outcome: Days to remove SP catheter      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean
Standard Deviation


3.5 years

N Analyzed 36 36
Mean
Standard Deviation 15 7
Outcome: Beta angle of urethra      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


3.5 years

N Analyzed 36 36
Mean 140 and 163 135 and 160
Standard Deviation 22 and 12 18 and 15


0 years

N Analyzed 36 36
Mean 115 and 123 119 and 128
Standard Deviation 15 and 21 11 and 19
Outcome: Time in hospital (days)      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean 8 16
Standard Deviation


3.5 years

N Analyzed
Mean
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Lyodura sling homologous lyophilized dura mater
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2 Burch
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Austria
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Sling Category Pubovaginal (bladder neck)
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Multicenter? No
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Institution Type Unclear/Not reported
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No. of Surgeons Performing the Procedures 1
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Surgeons' Training Urogynecology
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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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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Study Sponsor/Funding Not reported
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Results & Comparisons


Results Data
Outcome: SUI objective      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean not listed not listed
Standard Deviation


3 years

N Analyzed 33 31
Mean not listed not listed
Standard Deviation
Outcome: SUI subjective      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


3 years

N Analyzed not listed not listed
Mean
Standard Deviation


0 years

N Analyzed not listed not listed
Mean
Standard Deviation
Outcome: UUI objective      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean 0 0
Standard Deviation


3 years

N Analyzed 36 36
Mean 3 (#) 1 (#)
Standard Deviation
Outcome: UUI subjective      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


3 years

N Analyzed 36 36
Mean not listed not listed
Standard Deviation


0 years

N Analyzed 36 36
Mean not listed not listed
Standard Deviation
Outcome: de novo UUI      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean 1 (#) 1(#)
Standard Deviation


3 years

N Analyzed 36 36
Mean 6(#) 3(#)
Standard Deviation
Outcome: ISD patients (if applic)      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


3.5 years

N Analyzed 36 36
Mean 38 40
Standard Deviation 11 12


0 years

N Analyzed 36 36
Mean 40 50
Standard Deviation 13 10
Outcome: Days to remove SP catheter      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean
Standard Deviation


3.5 years

N Analyzed 36 36
Mean
Standard Deviation 15 7
Outcome: Beta angle of urethra      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


3.5 years

N Analyzed 36 36
Mean 140 and 163 135 and 160
Standard Deviation 22 and 12 18 and 15


0 years

N Analyzed 36 36
Mean 115 and 123 119 and 128
Standard Deviation 15 and 21 11 and 19
Outcome: Time in hospital (days)      Population: All Participants
Time Point Measure Lyodura sling Burch Lyodura sling Burch


0 years

N Analyzed 36 36
Mean 8 16
Standard Deviation


3.5 years

N Analyzed
Mean
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
Lyodura sling Infection, surgical site/wound Pyrexia (38.5C) for more than 2 d(not specifically listed by did track fevers) 2 36
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Burch 2 36
Total
Lyodura sling Organ injury in OR (urethra, bladder, bowel) bladder laceration 2 36
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Burch 1 36
Total
Lyodura sling voiding difficulty "late post op voiding difficutly" 5 36
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Burch 1 36
Total p<.05
Lyodura sling Days to remove SP catheter Measuring days required for voided volume >200ml and PVR <100ml. (Note, I have this in the RCT outcomes too) 15 36
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Burch 7 36
Total
Lyodura sling
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Burch
Total