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Study Title and Description

Retropubic vs Transobturator midurethral slings for SUI



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 Retropubic vs Transobturator midurethral slings for SUI
Author Richter et al
Country
Year 2010
Numbers Pubmed ID: 20479459
1970 (internal)

Secondary Publication Information
UI Title Author Country Year
Adverse events over 2 yrs after retropubic or transobturator midurethral sling surgery: findings from the TOMUS study Brubaker et al 2011
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The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology Albo, Steers for UITN 2008
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Sexual activity and function in women more than 2 years after midurethral sling placement Zyczynski HM and Rickey L and Dyer KY and Wilson T and Stoddard AM and Gormley EA and Hsu Y and Kusek JW and Brubaker L -- 2012
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Treatment success of retropubic and transobturator midurethral slings at 24 mos Albo ME and Litman HJ and Richter HE and Lemack GE and Sirls LT and Chai TC and Norton P and Kraus SR and Zyczynski H and Kenton K and Gormley EA and Kusek JW -- 2012
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Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 TVT
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2 transobturator TVT-O or Monarc
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Design Details
Question... Follow Up Answer Follow-up Answer
Trial Name TOMUS
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Country US
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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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Sexual function
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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Urodynamic SUI
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RCT Comparison Category Retropubic vs. Obturator
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Multicenter Yes
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Institution Type Academic hospital
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Community hospital
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Number of surgeons performing procedures ... Other ... 43
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Surgeons' Training Urogynecology
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Urology
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) A (good)
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Overall Study Notes well-designed RCT from UITN
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Study Sponsor/Funding Government
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Baseline Characteristics
Question TVT transobturator Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 298 299 597
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Mean Age 53 53
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Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos
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Results & Comparisons


Results Data
P-Value P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.75
Percentage 7 6


2 years

N Enrolled 253 263 0.9
Percentage 8.7 9
P-Value P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.19
Percentage 15 19


2 years

N Enrolled 253 263 0.049
Percentage 18 25
P-Value P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.18
Percentage 32 36


2 years

N Enrolled 253 263 0.19
Percentage 37 42
P-Value
Outcome: Choose a suggested Outcome...      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.14
Percentage 85.9 90
P-Value P-Value
Outcome: SUI retreatment      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.23
Percentage 3 5


2 years

N Enrolled 253 263 0.57
Percentage 4.7 5
P-Value P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.27
Percentage 21 25


2 years

N Enrolled 253 263 0.048
Percentage 28 36
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) percentage point difference P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) percentage point difference
Outcome: SUI Objective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292
Percentage 80.8 77.7 -3.6
9.6
3.0


2 years

N Enrolled 253 263
Percentage 77.3 72.3 -2.0
12.1
5.1
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) percentage point difference 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) percentage point difference
Outcome: SUI subjective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 -1.6
Percentage 62.2 55.8 14.3
6.4


2 years

N Enrolled 253 263 -0.7
Percentage 55.7 48.3 15.5
7.4
P-Value P-Value
Outcome: Postop urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 298 299 0.50
Percentage 0 1
Counts 0 0.3


2 years

N Enrolled 253 263 >0.99
Percentage 0 0.3
P-Value
Outcome: Retention      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 0.02
Percentage higher lower
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 days

N Analyzed 291 292 <0.001
Median 50 25
P-Value
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 days

N Analyzed 291 292 <0.001
Median 30 25
P-Value P-Value
Outcome: change UDI total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.41
Mean 106.7 110.3
Standard Deviation 48.0 51.2


2 years

N Analyzed 253 263 0.13
Mean 100 107
P-Value
Outcome: QOL - change UDI stress scale      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.82
Mean 61.2 61.8
Standard Deviation 27.5 27.7
P-Value
Outcome: QOL - change in UDI irritative scale      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.16
Mean 30.5 33.6
Standard Deviation 24.9 25.6
P-Value
Outcome: QOL - change UDI obstructive      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.96
Mean 15.0 14.9
Standard Deviation 17.9 16.2
P-Value P-Value
Outcome: QOL - change IIQ total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.47
Mean 126.8 132.9
Standard Deviation 94.5 97.8


2 years

N Analyzed 253 263 0.89
Mean 125 124
P-Value
Outcome: Sexual function      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 298 299 0.44
Mean 37 37


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
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2 Transobturator synthetic TVT-O or Monarc at surgeon discretion
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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 Active
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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? Yes
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Study Sponsor/Funding Government
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Results & Comparisons


Results Data
P-Value P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.75
Percentage 7 6


2 years

N Enrolled 253 263 0.9
Percentage 8.7 9
P-Value P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.19
Percentage 15 19


2 years

N Enrolled 253 263 0.049
Percentage 18 25
P-Value P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.18
Percentage 32 36


2 years

N Enrolled 253 263 0.19
Percentage 37 42
P-Value
Outcome: Choose a suggested Outcome...      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.14
Percentage 85.9 90
P-Value P-Value
Outcome: SUI retreatment      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.23
Percentage 3 5


2 years

N Enrolled 253 263 0.57
Percentage 4.7 5
P-Value P-Value
Outcome: SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 0.27
Percentage 21 25


2 years

N Enrolled 253 263 0.048
Percentage 28 36
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) percentage point difference P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) percentage point difference
Outcome: SUI Objective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292
Percentage 80.8 77.7 -3.6
9.6
3.0


2 years

N Enrolled 253 263
Percentage 77.3 72.3 -2.0
12.1
5.1
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) percentage point difference 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) percentage point difference
Outcome: SUI subjective success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 291 292 -1.6
Percentage 62.2 55.8 14.3
6.4


2 years

N Enrolled 253 263 -0.7
Percentage 55.7 48.3 15.5
7.4
P-Value P-Value
Outcome: Postop urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 298 299 0.50
Percentage 0 1
Counts 0 0.3


2 years

N Enrolled 253 263 >0.99
Percentage 0 0.3
P-Value
Outcome: Retention      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Enrolled 0.02
Percentage higher lower
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 days

N Analyzed 291 292 <0.001
Median 50 25
P-Value
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 days

N Analyzed 291 292 <0.001
Median 30 25
P-Value P-Value
Outcome: change UDI total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.41
Mean 106.7 110.3
Standard Deviation 48.0 51.2


2 years

N Analyzed 253 263 0.13
Mean 100 107
P-Value
Outcome: QOL - change UDI stress scale      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.82
Mean 61.2 61.8
Standard Deviation 27.5 27.7
P-Value
Outcome: QOL - change in UDI irritative scale      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.16
Mean 30.5 33.6
Standard Deviation 24.9 25.6
P-Value
Outcome: QOL - change UDI obstructive      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.96
Mean 15.0 14.9
Standard Deviation 17.9 16.2
P-Value P-Value
Outcome: QOL - change IIQ total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 264 263 0.47
Mean 126.8 132.9
Standard Deviation 94.5 97.8


2 years

N Analyzed 253 263 0.89
Mean 125 124
P-Value
Outcome: Sexual function      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT transobturator Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. transobturator


1 years

N Analyzed 298 299 0.44
Mean 37 37

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 + urethra; data same for 12, 24 mos reports 24 mos in hospital yes Dindo 16 298 <0.001
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Transobturator synthetic 24 mos in hospital yes Dindo 0 299 <0.001
Total
Retropubic synthetic vaginal epithelial perforation data same for 12, 24 mos reports 24 mos in hospital yes DIndo 6 298 0.16
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Transobturator synthetic 24 mos in hospital yes Dindo 13 299 0.16
Total
Retropubic synthetic Pulmonary embolus 24 mos in hospital yes DIndo 0 298 >0.99
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Transobturator synthetic 24 mos in hospital yes Dindo 1 299 >0.99
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue 24 mos in hospital yes Dindo 14 298 NS
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Transobturator synthetic 24 mos in hospital yes Dindo 9 299 NS
Total
Retropubic synthetic Infection, surgical site/wound 24 mos yes Dindo 2 298 NS
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Transobturator synthetic 24 mos yes Dindo 3 299 NS
Total
Retropubic synthetic Infection, UTI recurrent leading to diag cystoscopy 24 mos either yes Dindo 3 298 0.12
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Transobturator synthetic 24 mos either yes Dindo 0 299 0.12
Total
Retropubic synthetic Infection, UTI Total overall rate of culture proven UTIs 24 mos either no Dindo 25 298 0.07
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Transobturator synthetic 24 mos either no Dindo 14 299 0.07
Total
Retropubic synthetic Postop bleeding (combine serious/not serious) 24 mos in hospital both Dindo 7 298 0.02
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Transobturator synthetic 24 mos in hospital both Dindo 0 299 0.02
Total
Retropubic synthetic Pain, other (new or different after surgery) greater than 6 wk after surgery 24 mos after no Dindo 7 298 0.79
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Transobturator synthetic 24 mos after no Dindo 6 299 0.79
Total
Retropubic synthetic neurologic sx neurologic symptoms (combine serious/not serious) 24 mos after both Dindo 16 298 .04
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Transobturator synthetic 24 mos after both Dindo 29 299 .04
Total
Retropubic synthetic voiding dysfunction including reoperation and catheterization (not separated in paper) 24 mos both yes Dindo 9 298 0.002
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Transobturator synthetic 24 mos both yes Dindo 0 299 0.002
Total
Retropubic synthetic Infection, UTI first 6 wk 6 wk both 39 293 0.03
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Transobturator synthetic 6 wk both 23 297 0.03
Total