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Study Title and Description

A randomized comparison of transobturator tape and Burch colposuspension in the treatment of female stress urinary incontinence.



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 comparison of transobturator tape and Burch colposuspension in the treatment of female stress urinary incontinence.
Author Sivaslioglu AA., Caliskan E., Dolen I., Haberal A.
Country Ankara Etlik Maternity and Women's Health Teaching and Research Hospital, Ankara, Turkey. aas@tr.net
Year 2007
Numbers Pubmed ID: 17180553

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 Safyre-TOT - TOT Safyre performed under spinal anesthesia
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2 Burch
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Turkey
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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.) Urodynamic 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 Not reported
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Residents or fellows performing surgery? No
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Study Quality (overall) A (good)
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Overall Study Notes Could be Grade B b/c I think the only problem is the lack of power calculation; could have used more robust or better-described measures of objective and subjective cure. More careful evaluation for mesh-related complications in the TOT Safyre group needed.
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Study Sponsor/Funding ... Other ... unknown
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Baseline Characteristics
Question Safyre-TOT Burch TOT Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 49 51
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Mean Age 45.4 46.1
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Post-Op Follow-Up Interval (Maximum) 2yr 2yr
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Burch


0 years

N Enrolled 49 51
Counts
Standard Deviation


1 years

N Enrolled 49 51
Counts 42 42
Standard Deviation
.4


2 years

N Enrolled 32 31
Counts 28 26
Standard Deviation
.6
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Safyre-TOT


2 years

N Enrolled 32 31
Counts 28 27
Standard Deviation
.9


1 years

N Enrolled 49 51
Counts 42 43
Standard Deviation
.8


0 years

N Enrolled 49 51
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: De Novo Urge Incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Safyre-TOT


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 49 51
Counts 1 3
Standard Deviation
not reported


2 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Reoperation for SI (using TVT)      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Burch


2 years

N Enrolled 49 51
Counts 3 4
Standard Deviation
not reported


1 years

N Enrolled
Counts
Standard Deviation


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: surgical urethrolysis      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Safyre-TOT


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 49 51
Counts 1 1
Standard Deviation
not reported
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: Operative time      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Burch


0 years

N Analyzed 49 51
Mean 23.2 48
Standard Deviation
<.001


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Burch


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 49 51
Mean 1.8 4.3
Standard Deviation
<.001


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 TOT Safyre
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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 ... Other ... Turkey
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Sling Category Obturator synthetic
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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 Not reported
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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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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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Comments (overall study) I think the only problem is the lack of power calculation; could have used more robust or better-described measures of objective and subjective cure. More careful evaluation for mesh-related complications in the TOT Safyre group needed.
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Burch


0 years

N Enrolled 49 51
Counts
Standard Deviation


1 years

N Enrolled 49 51
Counts 42 42
Standard Deviation
.4


2 years

N Enrolled 32 31
Counts 28 26
Standard Deviation
.6
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Safyre-TOT


2 years

N Enrolled 32 31
Counts 28 27
Standard Deviation
.9


1 years

N Enrolled 49 51
Counts 42 43
Standard Deviation
.8


0 years

N Enrolled 49 51
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: De Novo Urge Incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Safyre-TOT


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 49 51
Counts 1 3
Standard Deviation
not reported


2 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Reoperation for SI (using TVT)      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Burch


2 years

N Enrolled 49 51
Counts 3 4
Standard Deviation
not reported


1 years

N Enrolled
Counts
Standard Deviation


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: surgical urethrolysis      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Safyre-TOT


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 49 51
Counts 1 1
Standard Deviation
not reported
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation
Outcome: Operative time      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Burch


0 years

N Analyzed 49 51
Mean 23.2 48
Standard Deviation
<.001


1 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure Safyre-TOT Burch TOT Burch Comparison Measure Safyre-TOT vs. Burch


2 years

N Analyzed
Mean
Standard Deviation


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 49 51
Mean 1.8 4.3
Standard Deviation
<.001

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
TOT Infection, UTI unclear 1 49 .3
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Burch 1 51
Total
TOT Organ injury in OR (urethra, bladder, bowel) bladder injury 0 49 not reported
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Burch 0 51
Total
TOT retention requiring catheter at post op day 1 Postvoid residual >100 cc. 6 49
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Burch 9 51 .4
Total
TOT retention requiring catheter at post op day 2 Postvoid residual >100 cc. 4 49 .5
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Burch 6 51
Total
TOT retention requiring catheter at post op day 3 Postvoid residual >100 cc. 1 49 .3
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Burch 3 51
Total