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Study Title and Description

A randomized controlled trial comparing a modified Burch procedure and a suburethral sling: long-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 A randomized controlled trial comparing a modified Burch procedure and a suburethral sling: long-term follow-up.
Author Culligan PJ, Goldberg RP, Sand PK.
Country Evanston Continence Center, Northwestern University Medical School, Evanston, Illinois, USA. pculligan@louisville.edu
Year 2003
Numbers Pubmed ID: 14530832
5 (internal)

Secondary Publication Information
UI Title Author Country Year
A prospective randomized study comparing modified Burch retropubic urethropexy and suburethral sling for treatment of genuine stress incontinence with low-pressure urethra. Sand PK., Winkler H., Blackhurst DW., Culligan PJ. Evanston Continence Center, Evanston Hospital, Northwestern University Medical School, IL, USA. 2000
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Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 PVS, Goretex • Horbach et al (ref 8) • Continuous Gortex soft tissue patch strip running from rectus fascia into retropubic space and beneath urethra at level of UVJ. • Sling tension determined by cotton swab testing. Minimal tension: resting angle of urethra was 0 to 10.
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2 Burch • Four 2-0 Goretex sutures • Tanagho modification (ref 7) • Sutures tied (out of T-berg), cotton swab at urethral meatus to level of UVJ, sutures tied so that the cotton swab made a -10 to -20 angle with the horizontal, measured with a goniometer. (vs standard tension of 0 to -5). Chosen to represent moderate increased tension on Burch sutures
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Design Details
Question... Follow Up Answer Follow-up Answer
Country US
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Outcome Categories Reported Objective SUI
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Subjective SUI
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Population (reason for surgery etc.) Symptomatic SUI
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RCT Comparison Category Sling vs. Burch
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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 ... Other ... It was not reported but the surgeon is Peter Sand a well known urogynecologist
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Not reported
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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 ... unknown
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Baseline Characteristics
Question PVS, Goretex Burch Goretex PVS Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 17 19
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Mean Age 60.4y 62.3y
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Post-Op Follow-Up Interval (Maximum) 72.6 mo (mean)
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective-stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Enrolled
Counts
Standard Deviation


72.6 months

N Enrolled 13 15 .17
Counts 0 15.4%
Standard Deviation
P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI obkective-Positive pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


72.6 months

N Enrolled 13 15 .39
Counts 0 7.6%
Standard Deviation


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Composite: objective cure of stress incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Enrolled
Counts
Standard Deviation


72.6 months

N Enrolled 13 15 .17
Counts 100% 84.6%
Standard Deviation
P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective 2      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


72 months

N Enrolled 13 15 .47
Counts 84% 93%
Standard Deviation


0 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Straining cotton-swab angle      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Analyzed
Mean
Standard Deviation


72.6 months

N Analyzed 13 16 .62
Mean -3.8 degrees -1.0 degrees
Standard Deviation
P-Value N Enrolled Mean Difference Standard Deviation
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure ERROR vs. ERROR


72.6 months

N Analyzed 15 13 .97
Mean 35mL 35mL
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Maximum flow      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure ERROR vs. ERROR


0 years

N Analyzed
Mean
Standard Deviation


72.6 months

N Analyzed 13 15 .85
Mean 14.8 15.36
Standard Deviation
P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Mean flow      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure ERROR vs. ERROR


72.6 months

N Analyzed 13 15 .58
Mean 6.80 7.38
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled P-Value N Enrolled Mean Difference Standard Deviation
Outcome: UUI subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


72 months

N Analyzed 13 15
Mean .31 .33 .93
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here
Outcome: SUI subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Analyzed
Mean
Standard Deviation


72 months

N Analyzed 13 15 .12
Mean .15 0
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Mean daily nocturia episodes      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


72.6 months

N Analyzed
Mean 13 15
Standard Deviation 1.19 1.25


0 years

N Analyzed .87
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Voiding frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Analyzed
Mean
Standard Deviation


72.6 months

N Analyzed 13 15 .04
Mean 2.7hr 3.2hr
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Goretex PVS
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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 US
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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 ... Other ... Only states Peter Sand as surgeon. He's a urogyn though
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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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
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective-stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Enrolled
Counts
Standard Deviation


72.6 months

N Enrolled 13 15 .17
Counts 0 15.4%
Standard Deviation
P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI obkective-Positive pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


72.6 months

N Enrolled 13 15 .39
Counts 0 7.6%
Standard Deviation


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Composite: objective cure of stress incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Enrolled
Counts
Standard Deviation


72.6 months

N Enrolled 13 15 .17
Counts 100% 84.6%
Standard Deviation
P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective 2      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


72 months

N Enrolled 13 15 .47
Counts 84% 93%
Standard Deviation


0 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Straining cotton-swab angle      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Analyzed
Mean
Standard Deviation


72.6 months

N Analyzed 13 16 .62
Mean -3.8 degrees -1.0 degrees
Standard Deviation
P-Value N Enrolled Mean Difference Standard Deviation
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure ERROR vs. ERROR


72.6 months

N Analyzed 15 13 .97
Mean 35mL 35mL
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Maximum flow      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure ERROR vs. ERROR


0 years

N Analyzed
Mean
Standard Deviation


72.6 months

N Analyzed 13 15 .85
Mean 14.8 15.36
Standard Deviation
P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Mean flow      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure ERROR vs. ERROR


72.6 months

N Analyzed 13 15 .58
Mean 6.80 7.38
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled P-Value N Enrolled Mean Difference Standard Deviation
Outcome: UUI subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


72 months

N Analyzed 13 15
Mean .31 .33 .93
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here
Outcome: SUI subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Analyzed
Mean
Standard Deviation


72 months

N Analyzed 13 15 .12
Mean .15 0
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Mean daily nocturia episodes      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


72.6 months

N Analyzed
Mean 13 15
Standard Deviation 1.19 1.25


0 years

N Analyzed .87
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Voiding frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure PVS, Goretex Burch Goretex PVS Burch Comparison Measure PVS, Goretex vs. Burch


0 years

N Analyzed
Mean
Standard Deviation


72.6 months

N Analyzed 13 15 .04
Mean 2.7hr 3.2hr
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
Goretex PVS Mesh erosion/extrusion/exposure/granulation tissue 12w 0 17
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Burch 12w 0 19
Total
Goretex PVS Obstruction requiring reoperation 5mo 1 13
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Burch 0 15
Total
Goretex PVS Organ injury in OR (urethra, bladder, bowel) cystotomy at time of surgery 0 17
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Burch 1 19
Total
Goretex PVS Retention requiring surgery Unclear, but some pts with retention (1 patient in Burch with severe retention pre and post op)
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Burch
Total
Goretex PVS
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Burch
Total