This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



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)
  • Comments Comments (
    0
    ) |
2 Sling Adverse Events
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
2 TOT type unclear
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Trial Name n/a
  • Comments Comments (
    0
    ) |
Country Iran
  • Comments Comments (
    0
    ) |
Outcome Categories Reported OR outcomes/complications (not "AEs")
  • Comments Comments (
    0
    ) |
Other (we expect this to rarely or never be chosen) ... "Cure" - unclear if subjective or objective; satisfaction
  • Comments Comments (
    0
    ) |
Population (reason for surgery etc.) Symptomatic SUI
  • Comments Comments (
    0
    ) |
Urodynamic SUI
  • Comments Comments (
    0
    ) |
RCT Comparison Category Sling vs. Burch
  • Comments Comments (
    0
    ) |
Multicenter No
  • Comments Comments (
    0
    ) |
Institution Type Unclear/Not reported
  • Comments Comments (
    0
    ) |
Number of surgeons performing procedures 1
  • Comments Comments (
    0
    ) |
Surgeons' Training Not reported
  • Comments Comments (
    0
    ) |
Residents or fellows performing surgery? No
  • Comments Comments (
    0
    ) |
Study Quality (overall) C (poor)
  • Comments Comments (
    0
    ) |
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.
  • Comments Comments (
    0
    ) |
Study Sponsor/Funding ... Other ... report no conflicts of interest
  • Comments Comments (
    0
    ) |


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
  • Comments Comments (
    0
    ) |
Mean Age 47 49
  • Comments Comments (
    0
    ) |
Post-Op Follow-Up Interval (Maximum) 28 mos 22 mos
  • Comments Comments (
    0
    ) |



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
  • Comments Comments (
    0
    ) |
2 Burch
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
  • Comments Comments (
    0
    ) |
Study Country Iran
  • Comments Comments (
    0
    ) |
Sling Category Obturator synthetic
  • Comments Comments (
    0
    ) |
Other ... Burch
  • Comments Comments (
    0
    ) |
Multicenter? No
  • Comments Comments (
    0
    ) |
Adverse Event Ascertainment Unclear/Not reported
  • Comments Comments (
    0
    ) |
Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
  • Comments Comments (
    0
    ) |
Was a data safety monitoring board used? No / Not reported
  • Comments Comments (
    0
    ) |
Comments (overall study) Poor quality study. See RCT form.
  • Comments Comments (
    0
    ) |




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
  • Comments Comments (
    0
    ) |
Burch 28 mos unstated 31
Total
Transobturator synthetic Organ injury in OR (urethra, bladder, bowel) 22 mos in hospital no undefined 0 31 ns
  • Comments Comments (
    0
    ) |
Burch 28 mos in hospital no undefined 0 31 ns
Total
Transobturator synthetic Infection, UTI 22 mos after no undefined 0 31 ns
  • Comments Comments (
    0
    ) |
Burch 28 mos after no undefined 0 31 ns
Total
Transobturator synthetic DVT 22 mos unclear yes undefined 0 31 0.32
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
Burch 28 mos unclear no undefined 9.7 31 0.07
Total