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Study Title and Description

Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results.



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 Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results.
Author Andonian S., Chen T., St-Denis B., Corcos J.
Country Division of Urology, Department of Surgery, Sir Mortimer B. Davis-Jewish General Hospital, McGill University, 3755 Côte Ste-Catherine, Suite E208, Montreal, Quebec, Canada, H3T 1E2.
Year 2005
Numbers Pubmed ID: 15774255
1873 (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 SPARC
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2 TVT
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Canada
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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.) Symptomatic SUI
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RCT Comparison Category ... Other comparison ... retropubic (TVT) vs retropubic (SPARC)
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures Not reported
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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) B (fair)
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Overall Study Notes Small study powered to detect a 30% difference (i.e. not much power)
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Study Sponsor/Funding ... Other ... not reported
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Baseline Characteristics
Question SPARC TVT Retropubic synthetic Retropubic synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 41 43 84
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Mean Age 62.6yr 60.4yr
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Post-Op Follow-Up Interval (Maximum) 1yr 1yr
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI cure objective      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 41 42
Counts 34 40
Standard Deviation
<.1 (yes they put .1)
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Bladder perforation      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


0 years

N Enrolled 41 43
Counts 10 10
Standard Deviation
no difference


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Patients with >250ml blood loss      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


0 years

N Enrolled 41 43
Counts
Standard Deviation 4 3
no difference


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Patients with post op analgesia      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


1 years

N Enrolled
Counts
Standard Deviation


0 years

N Enrolled 41 43
Counts 14 22
Standard Deviation
not given
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


0 years

N Enrolled 41 43
Counts 1 1
Standard Deviation
not given


1 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: SUI subjective IIQ score      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


1 years

N Analyzed 41 42
Mean 49.9 45.3
Standard Deviation
.46


0 years

N Analyzed 41 43
Mean 65.5 61.3
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 41 43
Mean 50 50
Standard Deviation
no diff


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic SPARC
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2 Retropubic synthetic TVT
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Canada
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Sling Category ... Other ... retropubic SPARC vs retropubic TVT
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Multicenter? No
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training Not reported
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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 Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI cure objective      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 41 42
Counts 34 40
Standard Deviation
<.1 (yes they put .1)
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Bladder perforation      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


0 years

N Enrolled 41 43
Counts 10 10
Standard Deviation
no difference


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Patients with >250ml blood loss      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


0 years

N Enrolled 41 43
Counts
Standard Deviation 4 3
no difference


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Patients with post op analgesia      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


1 years

N Enrolled
Counts
Standard Deviation


0 years

N Enrolled 41 43
Counts 14 22
Standard Deviation
not given
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


0 years

N Enrolled 41 43
Counts 1 1
Standard Deviation
not given


1 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: SUI subjective IIQ score      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


1 years

N Analyzed 41 42
Mean 49.9 45.3
Standard Deviation
.46


0 years

N Analyzed 41 43
Mean 65.5 61.3
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT Retropubic synthetic Retropubic synthetic Comparison Measure SPARC vs. TVT


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 41 43
Mean 50 50
Standard Deviation
no diff

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 Mesh erosion/extrusion/exposure/granulation tissue Tape erosion into the vagina requiring partial tape removal 1 41 ---
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Retropubic synthetic 0 43
Total
Retropubic synthetic Infection, surgical site/wound infected hematoma needing IV abx and percutaneous drainage 1 41 ---
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Retropubic synthetic 0 43
Total
Retropubic synthetic Infection, other Fever postop day #1 necessitating broad spec antibiotics x 1 week 1 41 ---
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Retropubic synthetic 0 43
Total
Retropubic synthetic Complete retention Immediate postoperative retention 2 41 .36
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Retropubic synthetic 4 43
Total
Retropubic synthetic Retention requiring surgery Return to OR to loosen tape after 3 days 2 41
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Retropubic synthetic 2 43
Total
Retropubic synthetic bladder perforation reported as an outcome above 10 41 no difference
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Retropubic synthetic 10 43
Total