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Study Title and Description

A randomized, controlled trial comparing an innovative single incision sling with an established transobturator sling to treat female stress urinary incontinence



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 A randomized, controlled trial comparing an innovative single incision sling with an established transobturator sling to treat female stress urinary incontinence
Author Hinoul, Vervest, den Boon, Venema, Lakeman, Milani, Roovers
Country --
Year 2011
Numbers Pubmed ID: 21334682
1850 (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-Secur H
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2 TVT-O
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Belgium and Netherlands
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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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RCT Comparison Category Minisling vs. Other
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Multicenter Yes
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Institution Type Academic hospital
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Number of surgeons performing procedures ... Other ... 6 centers - report they have "extensive experience"
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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) A (good)
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Overall Study Notes Funded bu Ethicon but their involvement not clear. Site-specific numbers (6 sites) not available. Study can be applied to pt with mixed UI as these were not excluded. Results not applicable to pts with prolapse that undergo a concomitant prolapse surgery. The hammock application for TVT-Secure was used so results should be limited to this application and not the U . Surgeons experience with TVT-Secure was very limited which could have accounted for the higher failure rate and complication rate in this group. Sexual function was not assessed.
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Study Sponsor/Funding Industry
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Baseline Characteristics
Question TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 97 98 195
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Mean Age 52.3 53.2 n/a
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Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos
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Results & Comparisons


Results Data
Statistical Test: P-Value Enter a Title Here
Outcome: Objective SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


12 months

N Enrolled 75 85
Percentage 16.4% 2.4% 0.002
Statistical Test: P-Value Enter a Title Here
Outcome: Subjective SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-O vs. TVT-Secur H


12 months

N Enrolled 75 85
Percentage 24.0 8.3 0.008
Statistical Test: P-Value Enter a Title Here
Outcome: Urgency and/or urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


12 months

N Enrolled 75 65
Percentage 23.0 16.7 not given
Statistical Test: P-Value Enter a Title Here
Outcome: Activities of daily life      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 weeks

N Enrolled
Counts < 0.05
Standard Deviation
text less affected including picking up an object, running, walking, dressing independently and getting in/out of bed
Statistical Test: P-Value Enter a Title Here
Outcome: Activities of daily life      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


2 weeks

N Enrolled
Counts not given
Standard Deviation
text only walking was still negatively affected in this group
Statistical Test: P-Value Text
Outcome: Activities of daily life      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


6 weeks

N Enrolled
Counts no diff between groups on any measure
Outcome: de novo UUI      Population: All Participants
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic


12 months

N Enrolled 75 65
Counts 12 14
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI)
Outcome: Re-intervention for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


12 months

N Enrolled 75 65 2.3
Counts 14 0 1.9-2.7
Statistical Test: P-Value Enter a Title Here
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Enrolled 96 92
Counts 74 59 0.02
Standard Deviation 23 51
Statistical Test: P-Value Enter a Title Here
Outcome: operative time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Enrolled 96 92
Counts 18 16 0.01
Standard Deviation 7 6
Statistical Test: P-Value Enter a Title Here
Outcome: hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Enrolled 96 92
Counts 23 25 0.90
Standard Deviation 17 24
Statistical Test: P-Value Enter a Title Here
Outcome: catheterization time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Enrolled 96 92
Counts 6 5 0.03
Standard Deviation 11 6
Statistical Test: P-Value Enter a Title Here
Outcome: pain med use      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Enrolled 82 87
Counts 60 75 <0.01
Percentage 73.1% 86.2%
Statistical Test: P-Value Enter a Title Here
Outcome: pain med use      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


5 days

N Enrolled 82 87
Counts 10 24 0.01
Percentage 12.1% 27.6%
Outcome: pain med use      Population: All Participants
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic


6 days

N Enrolled
text No difference past 5 days
Mean Difference P-Value
Outcome: QOL (disease specific)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


12 months

N Analyzed 75 90
Mean 20 13 <0.01
Mean Difference P-Value
Outcome: QOL (general)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed not given not given
Mean not given not given not different (no #)
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Analyzed 79 83
Mean 23 45 <0.01
Standard Deviation
P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Analyzed 79 83 <0.01
Mean 21 38
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


2 days

N Analyzed 79 83
Mean 15 31 < 0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


3 days

N Analyzed 79 83 <0.01
Mean 11 29
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


4 days

N Analyzed 79 83
Mean 10 28 < 0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


5 days

N Analyzed 79 83
Mean 9 22 <0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-O vs. TVT-Secur H


7 days

N Analyzed 79 83
Mean 8 18 <0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


14 days

N Analyzed 79 83
Mean 5 15 <0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


42 days

N Analyzed 79 83
Mean 5 7 not given - not diff
Mean Difference P-Value
Outcome: UI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 75 65 8
Mean 21 13 <0.01
Standard Deviation 24 21
Mean Difference P-Value
Outcome: QOL (UDI OAB subscale)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 63 90
Mean 12 12 no diff


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling obturator
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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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Study Country ... Other ... Belgium and Netherlands
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Sling Category Obturator synthetic
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Minisling H (obturator)
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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 Industry
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Comments (overall study) no concerns
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Results & Comparisons


Results Data
Statistical Test: P-Value Enter a Title Here
Outcome: Objective SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


12 months

N Enrolled 75 85
Percentage 16.4% 2.4% 0.002
Statistical Test: P-Value Enter a Title Here
Outcome: Subjective SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-O vs. TVT-Secur H


12 months

N Enrolled 75 85
Percentage 24.0 8.3 0.008
Statistical Test: P-Value Enter a Title Here
Outcome: Urgency and/or urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


12 months

N Enrolled 75 65
Percentage 23.0 16.7 not given
Statistical Test: P-Value Enter a Title Here
Outcome: Activities of daily life      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 weeks

N Enrolled
Counts < 0.05
Standard Deviation
text less affected including picking up an object, running, walking, dressing independently and getting in/out of bed
Statistical Test: P-Value Enter a Title Here
Outcome: Activities of daily life      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


2 weeks

N Enrolled
Counts not given
Standard Deviation
text only walking was still negatively affected in this group
Statistical Test: P-Value Text
Outcome: Activities of daily life      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


6 weeks

N Enrolled
Counts no diff between groups on any measure
Outcome: de novo UUI      Population: All Participants
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic


12 months

N Enrolled 75 65
Counts 12 14
Odds Ratio (OR) 95% Confidence Interval Lower Limit (95% LCI)
Outcome: Re-intervention for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


12 months

N Enrolled 75 65 2.3
Counts 14 0 1.9-2.7
Statistical Test: P-Value Enter a Title Here
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Enrolled 96 92
Counts 74 59 0.02
Standard Deviation 23 51
Statistical Test: P-Value Enter a Title Here
Outcome: operative time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Enrolled 96 92
Counts 18 16 0.01
Standard Deviation 7 6
Statistical Test: P-Value Enter a Title Here
Outcome: hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Enrolled 96 92
Counts 23 25 0.90
Standard Deviation 17 24
Statistical Test: P-Value Enter a Title Here
Outcome: catheterization time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Enrolled 96 92
Counts 6 5 0.03
Standard Deviation 11 6
Statistical Test: P-Value Enter a Title Here
Outcome: pain med use      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Enrolled 82 87
Counts 60 75 <0.01
Percentage 73.1% 86.2%
Statistical Test: P-Value Enter a Title Here
Outcome: pain med use      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


5 days

N Enrolled 82 87
Counts 10 24 0.01
Percentage 12.1% 27.6%
Outcome: pain med use      Population: All Participants
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic


6 days

N Enrolled
text No difference past 5 days
Mean Difference P-Value
Outcome: QOL (disease specific)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


12 months

N Analyzed 75 90
Mean 20 13 <0.01
Mean Difference P-Value
Outcome: QOL (general)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed not given not given
Mean not given not given not different (no #)
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


0 days

N Analyzed 79 83
Mean 23 45 <0.01
Standard Deviation
P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


1 days

N Analyzed 79 83 <0.01
Mean 21 38
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


2 days

N Analyzed 79 83
Mean 15 31 < 0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


3 days

N Analyzed 79 83 <0.01
Mean 11 29
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


4 days

N Analyzed 79 83
Mean 10 28 < 0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


5 days

N Analyzed 79 83
Mean 9 22 <0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-O vs. TVT-Secur H


7 days

N Analyzed 79 83
Mean 8 18 <0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure TVT-Secur H vs. TVT-O


14 days

N Analyzed 79 83
Mean 5 15 <0.01
Mean Difference P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


42 days

N Analyzed 79 83
Mean 5 7 not given - not diff
Mean Difference P-Value
Outcome: UI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 75 65 8
Mean 21 13 <0.01
Standard Deviation 24 21
Mean Difference P-Value
Outcome: QOL (UDI OAB subscale)      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-Secur H TVT-O Minisling obturator Transobturator synthetic Comparison Measure ERROR vs. ERROR


12 months

N Analyzed 63 90
Mean 12 12 no diff

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
Minisling obturator Bleeding >100cc
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Transobturator synthetic
Total
Minisling obturator Bleeding >500cc
  • Comments Comments (
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Transobturator synthetic
Total
Minisling obturator Cystotomy
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Transobturator synthetic
Total
Minisling obturator Vaginal perforation
  • Comments Comments (
    0
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Transobturator synthetic
Total
Minisling obturator Hematuria
  • Comments Comments (
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Transobturator synthetic
Total
Minisling obturator UTI
  • Comments Comments (
    0
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Transobturator synthetic
Total
Minisling obturator pyelo
  • Comments Comments (
    0
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Transobturator synthetic
Total
Minisling obturator urinary retention
  • Comments Comments (
    0
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Transobturator synthetic
Total
Minisling obturator Wound infection
  • Comments Comments (
    0
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Transobturator synthetic
Total
Minisling obturator mesh tape exposure
  • Comments Comments (
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Transobturator synthetic
Total
Minisling obturator tape takedown
  • Comments Comments (
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Transobturator synthetic
Total
Minisling obturator Organ injury in OR (urethra, bladder, bowel) bladder; resulted in hematuria and conversion to TVT-O 12 mos OR no not given 1 96 no diff not given
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Transobturator synthetic 12 mos OR no not given 0 92 no diff not given
Total
Minisling obturator vaginal perforation vaginal perforation 12 mos OR no not given 1 96 no diff not given
  • Comments Comments (
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Transobturator synthetic 12 mos OR no not given 0 92 no diff not given
Total
Minisling obturator Infection, UTI UTI + pyelo 12 mos postop no not given 7 96 no diff none given
  • Comments Comments (
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Transobturator synthetic 12 mos postop no not given 2 92 no diff none given
Total
Minisling obturator Infection, surgical site/wound 12 mos postop no not given 1 96 no diff none given
  • Comments Comments (
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Transobturator synthetic 12 mos postop no not given 0 92 no diff none given
Total
Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue 12 mos postop no not given 7 96 no diff none given
  • Comments Comments (
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Transobturator synthetic 12 mos postop no not given 1 92 no diff none given
Total
Minisling obturator Obstruction requiring reoperation take down for voiding dysfunction 12 mos postop no not given 2 96 no diff none given
  • Comments Comments (
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Transobturator synthetic 12 mos postop no not given 0 92 no diff none given
Total
Minisling obturator
  • Comments Comments (
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Transobturator synthetic
Total