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Study Title and Description

TOT for treatment of stress urinary incontinence: how should we assess its equivalence with TVT?



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 TOT for treatment of stress urinary incontinence: how should we assess its equivalence with TVT?
Author El-Hefnawy AS., Wadie BS., El Mekresh M., Nabeeh A., Bazeed MA.
Country Mansoura Urology and Nephrology Center, Urology Department, Mansoura University, Mansoura, Egypt. a_s_elhefnawy@yahoo.com
Year 2010
Numbers Pubmed ID: 20424826
1009 (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 TVT
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2 TOT as per Delorme
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Egypt
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Outcome Categories Reported Objective SUI
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Subjective SUI
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Quality of life
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Urodynamic SUI
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Mixed incontinence
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Concomitant prolapse surgery
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RCT Comparison Category Retropubic vs. Obturator
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Multicenter No
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Institution Type Unclear/Not reported
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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) C (poor)
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Study Sponsor/Funding ... Other ... Unclear
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Baseline Characteristics
Question TVT TOT Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 19 21
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Mean Age 47 45
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Post-Op Follow-Up Interval (Maximum) 20.8 mo 18.8 mo 19.7 mo
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Results & Comparisons


Results Data
P-Value
Outcome: Stress-specific success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 93.8 86.7 0.5
P-Value
Outcome: Overall success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 93.8 66.7 0.06
P-Value
Outcome: Cough stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 93.8 86.7 0.5
P-Value
Outcome: Negative pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 87.5 73.5 0.3
P-Value
Outcome: Passing Anti-incontinence score (AIS)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 100 84.6 0.6
P-Value
Outcome: Time in OR--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 19 21 0.1
Mean 23.8 19.6
Standard Deviation 4 5
P-Value
Outcome: EBL--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 19 21 0.8
Mean 52 40
Standard Deviation 14 13
P-Value
Outcome: Catheter duration      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 19 21 NS
Mean 3 3.3
Standard Deviation 1 3
P-Value
Outcome: Postop PVR--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 19 21 0.5
Mean 19 8
Standard Deviation 35 16


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
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2 Transobturator synthetic
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Sling Category Retropubic synthetic
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Obturator synthetic
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Adverse Event Ascertainment Unclear/Not reported
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Was the Clavien-Dindo Classification of Surgical Complications system used? Yes
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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
P-Value
Outcome: Stress-specific success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 93.8 86.7 0.5
P-Value
Outcome: Overall success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 93.8 66.7 0.06
P-Value
Outcome: Cough stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 93.8 86.7 0.5
P-Value
Outcome: Negative pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 87.5 73.5 0.3
P-Value
Outcome: Passing Anti-incontinence score (AIS)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

Percentage 100 84.6 0.6
P-Value
Outcome: Time in OR--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 19 21 0.1
Mean 23.8 19.6
Standard Deviation 4 5
P-Value
Outcome: EBL--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 19 21 0.8
Mean 52 40
Standard Deviation 14 13
P-Value
Outcome: Catheter duration      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 19 21 NS
Mean 3 3.3
Standard Deviation 1 3
P-Value
Outcome: Postop PVR--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 19 21 0.5
Mean 19 8
Standard Deviation 35 16

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 Organ injury in OR (urethra, bladder, bowel) Bladder injury Intraop In-hospital ND ND 0 19 ND ND
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Transobturator synthetic Intraop In-hospital 1 21
Total
Retropubic synthetic Infection, UTI Recurrent Unclear After discharge No Clavien II 1 ND (19?) ND ND
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Transobturator synthetic Unclear After discharge 1 ND (21?)
Total
Retropubic synthetic Pain, groin (new or different after surgery) thigh/ suprapubic Unclear After discharge No Clavien II/IIIa 1 ND (19?) ND ND
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Transobturator synthetic Unclear After discharge 3 ND (21?)
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue Vaginal - reoperation required Unclear After discharge Yes Clavien IIIb 0 ND (19?) ND ND
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Transobturator synthetic Unclear After discharge 1 ND (21?)
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Retropubic synthetic Subrapubic hematoma intervention not described Unclear Unclear No Clavien I 2 ND (19?) ND ND
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Transobturator synthetic Unclear Unclear 0 ND (21?)
Total
Retropubic synthetic "Vascular complication" Pelvic hematoma Periop In-hospital Yes Clavien IV-a 1 19 ND ND
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Transobturator synthetic Periop In-hospital 0 21
Total
Retropubic synthetic De novo dyspareunia Unclear After discharge ND ND 0 19 ND NA
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Transobturator synthetic Unclear After discharge 0 21
Total