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Study Title and Description

Randomised prospective single-blinded study comparing 'inside-out' versus 'outside-in' transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study.



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 Randomised prospective single-blinded study comparing 'inside-out' versus 'outside-in' transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study.
Author Abdel-Fattah M., Ramsay I., Pringle S., Hardwick C., Ali H., Young D., Mostafa A.
Country Division of Applied Health Science, University of Aberdeen, Aberdeen, UK. m.abdelfattah@abdn.ac.uk
Year 2010
Numbers Pubmed ID: 20394610
2693 (internal)

Secondary Publication Information
UI Title Author Country Year
Evaluation of transobturator tapes (E-TOT) study: randomised prospective single-blinded study comparing inside-out vs. outside-in transobturator tapes in management of urodynamic stress incontinence: short term outcomes. Abdel-fattah M., Ramsay I., Pringle S., Hardwick C., Ali H. Division of Applied Health Sciences, University Of Aberdeen, UK. m.abdelfattah@abdn.ac.uk 2010
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Prospective randomised controlled trial of transobturator tapes in management of urodynamic stress incontinence in women: 3-year outcomes from the Evaluation of Transobturator Tapes study. Abdel-Fattah M., Mostafa A., Familusi A., Ramsay I., N'dow J. Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, UK. m.abdelfattah@abdn.ac.uk 2012
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Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 TOT_out-to-in TOT-ARIS
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2 TVT-O
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Design Details
Question... Follow Up Answer Follow-up Answer
Country UK
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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.) Urodynamic SUI
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Intrinsic sphincter deficiency
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Recurrent incontinence after surgery
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Mixed incontinence
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RCT Comparison Category Obturator vs. Obturator
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures ... Other ... 2 Urogyn, 3 Gyn
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Surgeons' Training Urogynecology
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Other ... Gynecology
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) B (fair)
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Study Sponsor/Funding ... Other ... Unclear
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Baseline Characteristics
Question TOT_out-to-in TVT-O TVT-O Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 171 170
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Mean Age 52.1 51.5
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Post-Op Follow-Up Interval (Maximum) 12 mo 12 mo
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Results & Comparisons


Results Data
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: Negative pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

N Enrolled 109 121 2.21
Counts 96 114 0.85
Standard Deviation 88.1 94.2 5.75
0.157
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: PGI-I Success      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

N Analyzed 143 149 1.25
Counts 111 121 0.71
Percentage 77.6 81.2 2.20
0.54


3 years

N Analyzed 112 126 0.927
Counts 81 93 0.522
Percentage 72.3 73.8 1.645
0.796
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: Likert SUI tx satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

N Enrolled 141 141 0.84
Counts 113 109 0.48
Standard Deviation 80.1 77.3 1.50
0.662


3 years

N Analyzed 112 126 0.759
Counts 73 91 0.435
Percentage 66.4 72.2 1.322
0.33
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: ICIQ-SF success      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

N Enrolled 147 152 1.27
Counts 99 110 0.78
Standard Deviation 67.3 72.4 2.08
0.412


3 years

N Enrolled 112 126 0.874
Counts 66 79 0.514
Standard Deviation 60.6 63.7 1.486
0.62
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: Kings Health Q      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Percentage 77.6 88.0 1.093
3.757
0.034
P-Value
Outcome: EBL >200mL      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


0 months

N Analyzed 171 170 0.405
Counts 11 15
P-Value P-Value
Outcome: PISQ median improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 3.0 4.5 0.346


3 years

Value 4 5 0.317
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-general health improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 0.00 0.00 0.695
0.001
0.003


3 years

Value 0 0 0.861
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-incontinence impact      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 66.67 66.67 0.771
-0.01
0.00


3 years

Value 66.67 66.67 0.537
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-role limitation      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 50.0 50.0 0.624
-16.67
0.00


3 years

Value 50 50 0.721
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-physical limitation      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 50.0 50.0 0.637
-16.67
0.00


3 years

Value 50 50 0.369
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-social limitation      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 22.22 33.33 0.104
-11.11
0.00


3 years

Value 22.22 33.33 0.242
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-personal relationships      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 0.00 2.00 0.7
-0.33
0.00


3 years

Value 33.33 33.33 0.653
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-sleep/energy      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 16.67 16.67 0.976
0.00
0.00


3 years

Value 33.33 33.33 0.447
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-severity measure      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 41.67 50.00 0.099
-16.67
0.00


3 years

Value 50 50 0.731
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-average score      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 35.19 35.65 0.419
-8.03
3.70


3 years

Value 39.198 39.81 0.356


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 TVT-O in to out
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2 Transobturator synthetic TOT-ARIS (out-to-in)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Name E-TOT
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Sling Category Obturator synthetic
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Adverse Event Ascertainment Active
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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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Results & Comparisons


Results Data
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: Negative pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

N Enrolled 109 121 2.21
Counts 96 114 0.85
Standard Deviation 88.1 94.2 5.75
0.157
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: PGI-I Success      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

N Analyzed 143 149 1.25
Counts 111 121 0.71
Percentage 77.6 81.2 2.20
0.54


3 years

N Analyzed 112 126 0.927
Counts 81 93 0.522
Percentage 72.3 73.8 1.645
0.796
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: Likert SUI tx satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

N Enrolled 141 141 0.84
Counts 113 109 0.48
Standard Deviation 80.1 77.3 1.50
0.662


3 years

N Analyzed 112 126 0.759
Counts 73 91 0.435
Percentage 66.4 72.2 1.322
0.33
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: ICIQ-SF success      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

N Enrolled 147 152 1.27
Counts 99 110 0.78
Standard Deviation 67.3 72.4 2.08
0.412


3 years

N Enrolled 112 126 0.874
Counts 66 79 0.514
Standard Deviation 60.6 63.7 1.486
0.62
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value
Outcome: Kings Health Q      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Percentage 77.6 88.0 1.093
3.757
0.034
P-Value
Outcome: EBL >200mL      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


0 months

N Analyzed 171 170 0.405
Counts 11 15
P-Value P-Value
Outcome: PISQ median improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 3.0 4.5 0.346


3 years

Value 4 5 0.317
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-general health improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 0.00 0.00 0.695
0.001
0.003


3 years

Value 0 0 0.861
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-incontinence impact      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 66.67 66.67 0.771
-0.01
0.00


3 years

Value 66.67 66.67 0.537
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-role limitation      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 50.0 50.0 0.624
-16.67
0.00


3 years

Value 50 50 0.721
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-physical limitation      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 50.0 50.0 0.637
-16.67
0.00


3 years

Value 50 50 0.369
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-social limitation      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 22.22 33.33 0.104
-11.11
0.00


3 years

Value 22.22 33.33 0.242
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-personal relationships      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 0.00 2.00 0.7
-0.33
0.00


3 years

Value 33.33 33.33 0.653
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-sleep/energy      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 16.67 16.67 0.976
0.00
0.00


3 years

Value 33.33 33.33 0.447
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-severity measure      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 41.67 50.00 0.099
-16.67
0.00


3 years

Value 50 50 0.731
P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: KHQ-average score      Population: All Participants Between-Arm Comparisons
Time Point Measure TOT_out-to-in TVT-O TVT-O Transobturator synthetic Comparison Measure TOT_out-to-in vs. TVT-O


12 months

Value 35.19 35.65 0.419
-8.03
3.70


3 years

Value 39.198 39.81 0.356

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
TVT-O Organ injury in OR (urethra, bladder, bowel) Vaginal angle injury Intraop in-hospital No ND 3 170 ND 0.001
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Transobturator synthetic 17 171
Total
TVT-O Organ injury in OR (urethra, bladder, bowel) Bladder injury Intraop in-hospital No ND 1 170 ND 1
  • Comments Comments (
    0
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Transobturator synthetic 1 171
Total
TVT-O Organ injury in OR (urethra, bladder, bowel) Urethra Intraop in-hospital No ND 0 170 ND 1
  • Comments Comments (
    0
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Transobturator synthetic 1 171
Total
TVT-O Mesh erosion/extrusion/exposure/granulation tissue Vaginal <6mo After discharge ND ND 3 170 ND 0.723
  • Comments Comments (
    0
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Transobturator synthetic 5 171
Total
TVT-O Short term voiding dysfunction Catheter req'd 24h 24h In-hospital No ND 8 170 ND 0.57
  • Comments Comments (
    0
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Transobturator synthetic 6 171
Total
TVT-O Short term voiding dysfunction Catheter req'd 5-7d 5-7d After discharge No ND 1 170 ND 0.82
  • Comments Comments (
    0
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Transobturator synthetic 2 171
Total
TVT-O Short term voiding dysfunction Catheter req'd 2wk 2wk After discharge No ND 1 170 ND 1
  • Comments Comments (
    0
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Transobturator synthetic 1 171
Total
TVT-O Retention requiring surgery Tape release under gen anesth <6mo After discharge ND ND 1 170 ND 0.91
  • Comments Comments (
    0
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Transobturator synthetic 0 171
Total
TVT-O Pain, groin (new or different after surgery) score 7 or greater Unclear (<6mo) After discharge ND ND 27 150 ND 0.226
  • Comments Comments (
    0
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Transobturator synthetic 19 147
Total
TVT-O Pain, other (new or different after surgery) Hip pain scored 7 or greater Unclear (<6mo) After discharge ND ND 34 150 ND 0.285
  • Comments Comments (
    0
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Transobturator synthetic 26 147
Total
TVT-O Mesh erosion/extrusion/exposure/granulation tissue total by 3yrs - one at 14mo, 1 at 19 mo 36 mo After discharge ND ND 3 126 ND ND
  • Comments Comments (
    0
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Transobturator synthetic 7 112
Total