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Study Title and Description

Comparison of transobturator tape (TOT) vs Burch method in treatment of 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 Comparison of transobturator tape (TOT) vs Burch method in treatment of stress urinary incontinence.
Author Bandarian M., Ghanbari Z., Asgari A.
Country Department of Obstetrics and Gynecology, Vali-e-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Year 2011
Numbers Pubmed ID: 21823854
1485 (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 Burch
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2 TOT type unclear
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Design Details
Question... Follow Up Answer Follow-up Answer
Trial Name n/a
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Country Iran
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Outcome Categories Reported OR outcomes/complications (not "AEs")
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Other (we expect this to rarely or never be chosen) ... "Cure" - unclear if subjective or objective; satisfaction
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Population (reason for surgery etc.) Symptomatic SUI
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Urodynamic SUI
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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 Not reported
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Residents or fellows performing surgery? No
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Study Quality (overall) C (poor)
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Overall Study Notes No power analysis; no standardized measures used. Unclear what urodynamic data were collected. Unclear if "cure" was subjective or objective or both. "Simple" randomization scheme used. Single surgeon. Follow-up done by another surgeon. Complication rate for Burch about twice as high as TOT but apparently statistically similar.
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Study Sponsor/Funding ... Other ... report no conflicts of interest
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Baseline Characteristics
Question Burch TOT Transobturator synthetic Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 31 31 62
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Mean Age 47 49
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Post-Op Follow-Up Interval (Maximum) 28 mos 22 mos
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Results & Comparisons


Results Data
P-Value
Outcome: Overall complication rate      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


Enter a numeric value or title (required) years

 N Enrolled 31 31 0.199
Percentage 25.8 12.9
P-Value
Outcome: Postop urinary retention      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure TOT vs. Burch


1 weeks

 N Enrolled 31 31 0.3
Percentage 9.7 3.2
P-Value
Outcome: Bladder/urethral injury      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 days

 N Enrolled 31 31 ns
Percentage 0 0
P-Value
Outcome: Cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 unclear

 N Enrolled 31 31 ns
Percentage 74.2 90.3
P-Value
Outcome: Improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 unclear

 N Enrolled 31 31 ns
Percentage 19.4 6.7
P-Value
Outcome: Failure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 unclear

 N Enrolled 31 31 ns
Percentage 6.5 0
P-Value
Outcome: "very satisfied"      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 unclear

 N Enrolled 31 31 ns
Percentage 74.2 90.3
P-Value
Outcome: EBL >300cc      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 days

 N Enrolled 31 31 ns
Percentage 3.2 3.2
N Enrolled P-Value
Outcome: Duration of procedure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


Enter a numeric value or title (required) years

 N Analyzed 31 31 62
Mean 45 20 <0.001
Standard Deviation
Range 40-55 15-25
N Enrolled P-Value
Outcome: Length of hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


Enter a numeric value or title (required) years

 N Analyzed 31 31 62
Mean 8.23 2.06 0.001
Standard Deviation 3.98 1.03


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Transobturator synthetic
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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 Iran
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Sling Category Obturator synthetic
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Other ... Burch
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Multicenter? No
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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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Comments (overall study) Poor quality study. See RCT form.
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Results & Comparisons


Results Data
P-Value
Outcome: Overall complication rate      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


Enter a numeric value or title (required) years

 N Enrolled 31 31 0.199
Percentage 25.8 12.9
P-Value
Outcome: Postop urinary retention      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure TOT vs. Burch


1 weeks

 N Enrolled 31 31 0.3
Percentage 9.7 3.2
P-Value
Outcome: Bladder/urethral injury      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 days

 N Enrolled 31 31 ns
Percentage 0 0
P-Value
Outcome: Cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 unclear

 N Enrolled 31 31 ns
Percentage 74.2 90.3
P-Value
Outcome: Improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 unclear

 N Enrolled 31 31 ns
Percentage 19.4 6.7
P-Value
Outcome: Failure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 unclear

 N Enrolled 31 31 ns
Percentage 6.5 0
P-Value
Outcome: "very satisfied"      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 unclear

 N Enrolled 31 31 ns
Percentage 74.2 90.3
P-Value
Outcome: EBL >300cc      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


1 days

 N Enrolled 31 31 ns
Percentage 3.2 3.2
N Enrolled P-Value
Outcome: Duration of procedure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


Enter a numeric value or title (required) years

 N Analyzed 31 31 62
Mean 45 20 <0.001
Standard Deviation
Range 40-55 15-25
N Enrolled P-Value
Outcome: Length of hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch TOT Transobturator synthetic Burch Comparison Measure Burch vs. TOT


Enter a numeric value or title (required) years

 N Analyzed 31 31 62
Mean 8.23 2.06 0.001
Standard Deviation 3.98 1.03

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
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue mentioned in discussion that one person in TOT group had erosion - treated with antibiotics 22 mos after no not defined 1 31 not given not given
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Burch 28 mos unstated 31
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Transobturator synthetic Organ injury in OR (urethra, bladder, bowel) 22 mos in hospital no undefined 0 31 ns
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Burch 28 mos in hospital no undefined 0 31 ns
Total
Transobturator synthetic Infection, UTI 22 mos after no undefined 0 31 ns
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Burch 28 mos after no undefined 0 31 ns
Total
Transobturator synthetic DVT 22 mos unclear yes undefined 0 31 0.32
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Burch 28 mos unclear yes undefined 3.2 31 0.32
Total
Transobturator synthetic Infection, surgical site/wound 22 mos unclear no undefined 0 31 0.07
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Burch 28 mos unclear no undefined 9.7 31 0.07
Total