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Study Title and Description

Three-year follow-up of tension-free vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency.



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 Three-year follow-up of tension-free vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency.
Author Schierlitz L., Dwyer PL., Rosamilia A., Murray C., Thomas E., De Souza A., Hiscock R.
Country Department of Urogynecology, Mercy Hospital for Women, Heidelberg, Victoria, Australia. lschierlitz@mercy.com.au
Year 2012
Numbers Pubmed ID: 22270284
2903 (internal)

Secondary Publication Information
UI Title Author Country Year
Sexual function following retropubic TVT and transobturator Monarc sling in women with intrinsic sphincter deficiency: a multicentre prospective study. De Souza A., Dwyer PL., Rosamilia A., Hiscock R., Lim YN., Murray C., Thomas E., Conway C., Schierlitz L. Department of Urogynaecology, Mercy Hospital for Women, Melbourne University, 163 Studley Rd, Heidelberg, Melbourne, Victoria 3084, Australia. adesouza@mercy.com.au 2012
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Effectiveness of tension-free vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency: a randomized controlled trial. Schierlitz L., Dwyer PL., Rosamilia A., Murray C., Thomas E., De Souza A., Lim YN., Hiscock R. Department of Urogynecology, Mercy Hospital for Women, Heidelberg, Australia. lschierlitz@mercy.com.au 2008
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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 TOT not specified in my paper
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Australia
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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.) Symptomatic SUI
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Urodynamic SUI
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Intrinsic sphincter deficiency
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RCT Comparison Category Retropubic vs. Obturator
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Multicenter Yes
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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) B (fair)
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Overall Study Notes First extraction - Schimpf; second - Margulies. Did not reach power: listed that there was slow recruitment of patients with intrinsic sphincter deficiency. Also 1 subject in TVT arm had TOT instead due to "repeated bladder perforations" but was kept in TVT arm for analysis. Schierlitz 2008 also extracted for periop outcomes and AEs. PMID 19037033. SRDR not allowing this additional information under "Publications" tab at present.
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Study Sponsor/Funding ... Other ... not stated
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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 82 82 164
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Mean Age 60 60
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Post-Op Follow-Up Interval (Maximum) No data entered.



Results & Comparisons


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


3 years

N Enrolled 72 75 <0.001
Counts 1 15
Standard Deviation
P-Value
Outcome: EBL >200 mL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Enrolled 82 82 0.16
Counts 7 14
Percentage 9 17
P-Value
Outcome: Time to repeat surgery performed      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 <0.001
Unit months months
Median 43.7 15.6
Range 0 11.8-41.4
P-Value
Outcome: Success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 0.32
Unit points points
Median 90 90
25-75th percentile 80-99 70-99
P-Value between-group difference P-Value between-group difference
Outcome: UDI 6 total score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 .78
Unit 0.2
Median 0 0
25-75th percentile 0-4 0-3


1 years

N Analyzed 24 24 0.72
Median 0.6 1.0 0.4
Standard Deviation 3.03 3.44
P-Value
Outcome: UDI-6 question 2      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 0.50
Unit
Median 1 1
25-75th percentile 0-1 0-2
P-Value
Outcome: UDI-6 question 3      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


3 years

N Analyzed 72 75 0.69
Unit
Median 0 0
25-75th percentile 0-1 0-1
P-Value between-group difference P-Value between-group difference
Outcome: IIQ-7 total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 .03
Unit 2.1
Median 0 0
25-75th percentile 0-4 0-3


1 years

N Analyzed 24 24 0.91
Median 0.8 0.1 -0.1
Standard Deviation 4.05 0.86
P-Value
Outcome: Days in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 82 82 0.18
Median 2 1
25th Percentile 1 1
75th Percentile 3 3
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 82 82 0.92
Median 50 50
25th Percentile 50 50
75th Percentile 200 200
P-Value P-Value
Outcome: PISQ12 total score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.51
Median -0.2 -1.0
Standard Deviation 4.2 6.50


0 years

N Analyzed 27 37
Median 28.6 30.8
Standard Deviation 5.81 5.54
P-Value P-Value
Outcome: PISQ12 question 5      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.91
Median -0.1 0.0
Standard Deviation 1.19 1.23


0 years

N Analyzed 27 37
Median 2 3
25th Percentile 2 2
75th Percentile 3 4
P-Value P-Value
Outcome: PISQ12 question 6      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.40
Median 0.0 -0.2
Standard Deviation 0.42 0.87


0 years

N Analyzed 27 37
Median 2 3
25th Percentile 1 2
75th Percentile 3 4
P-Value P-Value
Outcome: PISQ12 question 7      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.46
Median 0.0 -0.1
Standard Deviation 0.51 0.90


0 years

N Analyzed 27 37
Median 2 3
25th Percentile 1 2
75th Percentile 3 4
P-Value P-Value
Outcome: PISQ12 question 12      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.22
Median 0.1 0.0
Standard Deviation 1.33 1.08


0 years

N Analyzed 27 37
Median 1 2
25th Percentile 1 1
75th Percentile 2 2


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT
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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 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
P-Value
Outcome: Repeat surgery      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Enrolled 72 75 <0.001
Counts 1 15
Standard Deviation
P-Value
Outcome: EBL >200 mL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Enrolled 82 82 0.16
Counts 7 14
Percentage 9 17
P-Value
Outcome: Time to repeat surgery performed      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 <0.001
Unit months months
Median 43.7 15.6
Range 0 11.8-41.4
P-Value
Outcome: Success      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 0.32
Unit points points
Median 90 90
25-75th percentile 80-99 70-99
P-Value between-group difference P-Value between-group difference
Outcome: UDI 6 total score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 .78
Unit 0.2
Median 0 0
25-75th percentile 0-4 0-3


1 years

N Analyzed 24 24 0.72
Median 0.6 1.0 0.4
Standard Deviation 3.03 3.44
P-Value
Outcome: UDI-6 question 2      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 0.50
Unit
Median 1 1
25-75th percentile 0-1 0-2
P-Value
Outcome: UDI-6 question 3      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure ERROR vs. ERROR


3 years

N Analyzed 72 75 0.69
Unit
Median 0 0
25-75th percentile 0-1 0-1
P-Value between-group difference P-Value between-group difference
Outcome: IIQ-7 total      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


3 years

N Analyzed 72 75 .03
Unit 2.1
Median 0 0
25-75th percentile 0-4 0-3


1 years

N Analyzed 24 24 0.91
Median 0.8 0.1 -0.1
Standard Deviation 4.05 0.86
P-Value
Outcome: Days in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 82 82 0.18
Median 2 1
25th Percentile 1 1
75th Percentile 3 3
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


0 months

N Analyzed 82 82 0.92
Median 50 50
25th Percentile 50 50
75th Percentile 200 200
P-Value P-Value
Outcome: PISQ12 total score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.51
Median -0.2 -1.0
Standard Deviation 4.2 6.50


0 years

N Analyzed 27 37
Median 28.6 30.8
Standard Deviation 5.81 5.54
P-Value P-Value
Outcome: PISQ12 question 5      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.91
Median -0.1 0.0
Standard Deviation 1.19 1.23


0 years

N Analyzed 27 37
Median 2 3
25th Percentile 2 2
75th Percentile 3 4
P-Value P-Value
Outcome: PISQ12 question 6      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.40
Median 0.0 -0.2
Standard Deviation 0.42 0.87


0 years

N Analyzed 27 37
Median 2 3
25th Percentile 1 2
75th Percentile 3 4
P-Value P-Value
Outcome: PISQ12 question 7      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.46
Median 0.0 -0.1
Standard Deviation 0.51 0.90


0 years

N Analyzed 27 37
Median 2 3
25th Percentile 1 2
75th Percentile 3 4
P-Value P-Value
Outcome: PISQ12 question 12      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT


12 months

N Analyzed 24 24 0.22
Median 0.1 0.0
Standard Deviation 1.33 1.08


0 years

N Analyzed 27 37
Median 1 2
25th Percentile 1 1
75th Percentile 2 2

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 performation Intraop In-hospital ND ND 6 82 ND 0.06
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Transobturator synthetic 0 82
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Vaginal wall perforation Intraop In-hospital ND ND 0 82 ND 0.12
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Transobturator synthetic 4 82
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Urethral injury Intraop In-hospital ND ND 0 82 ND 0.99
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Transobturator synthetic 0 82
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bowel injury Intraop In-hospital ND ND 0 82 ND 0.99
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Transobturator synthetic 0 82
Total
Retropubic synthetic Transfusion post-op Intraop In-hospital ND ND 0 82 ND 0.99
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Transobturator synthetic 0 82
Total
Retropubic synthetic Return to OR Absecess at Lt groin site required surgery for drainage 6 mo After discharge ND ND 0 82 ND 0.50
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Transobturator synthetic 1 82
Total
Retropubic synthetic Pain, groin (new or different after surgery) short-term leg/ obturator pain Unclear (<6mo) After discharge ND ND 1 82 ND 0.62
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Transobturator synthetic 3 82
Total
Retropubic synthetic Pain, groin (new or different after surgery) long-term leg/ obturator pain 6 mo After discharge ND ND 0 82 ND 0.50
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Transobturator synthetic 1 82
Total
Retropubic synthetic Infection, surgical site/wound "Sling infection" 6 mo After discharge ND ND 0 82 ND 0.50
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Transobturator synthetic 1 82
Total
Retropubic synthetic Short-term voiding dysfunction requiring catheter 1-5 days After discharge ND ND 7 82 ND 0.20
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Transobturator synthetic 3 82
Total
Retropubic synthetic Short-term voiding dysfunction requiring CISC 5-28 days After discharge ND ND 2 82 ND 0.61
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Transobturator synthetic 1 82
Total
Retropubic synthetic Retention requiring surgery "Loosening of tape" 0-14 days After discharge ND ND 1 82 ND 0.75
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Transobturator synthetic 1 82
Total
Retropubic synthetic Retention requiring surgery "Division of tape" nclear (<6mo) After discharge ND ND 2 82 ND 0.50
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Transobturator synthetic 1 82
Total