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Study Title and Description

One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.



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 One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.
Author Andrada Hamer M., Larsson PG., Teleman P., Bergqvist CE., Persson J.
Country Department of Obstetrics and Gynecology, Skåne University Hospital, Lund and Lund University, Sweden, SE-22185, Lund, Sweden.
Year 2013
Numbers Pubmed ID: 22707006
2363 (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 TVT-Secur H
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Design Details
Question... Follow Up Answer Follow-up Answer
Trial Name SSISS
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Country Sweden
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Outcome Categories Reported Objective SUI
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Subjective SUI
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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Mixed incontinence
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RCT Comparison Category Minisling vs. Other
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Multicenter Yes
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Institution Type Unclear/Not reported
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Number of surgeons performing procedures ... Other ... 6
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Surgeons' Training ... 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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Overall Study Notes Three major complications (all secur) - study stopped early. No validated questionnaires on incontinence, QoL, sexual function, or postoperative assessment. Overall, a helpful and applicable addition to the literature on mini-slings. Truly, only 2 sites, university based, poor f/u for an RCT ("call if you have problems") Surgeons had little experience in placement of Secure. data indicates that it is different than placing TVT or TOT with regards to achieving good anchorage, avoiding urethral and bladder injury and voiding dysfunction as tensioning is different. they should have had more experience, say 20-30 slings experience in order to compare fairly. applicability should not be to all mini-slings but only to secure placed in the hammock fashion. studies show other mini-slings such as mini-arc is easier and significantly less associated with complications. Major flaw is that cysto was not done on the secure slings. Cystoscopy should have been performed on all secure slings. especially when surgeons have only been proctored in placing 5 sling. Two of the major adverse events in the secure group would most probably have been identified intraoperatively and the study could have continued. bladder perforation occurred with TVT but rectified during surgery because it was identified with cysto.
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Study Sponsor/Funding Industry
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Baseline Characteristics
Question TVT TVT-Secur H Minisling obturator Retropubic synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 69 64
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Mean Age 48 47
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Post-Op Follow-Up Interval (Maximum) 13 mos median 12 mos median
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Results & Comparisons


Results Data
P-Value
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 days

 Counts 58 50 0.0001
range 42-94 27-95
P-Value
Outcome: surgery time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 days

 Counts 22 13 <0.0001
range 13-36 7-25
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 days

 Percentage 63 52 0.41
P-Value
Outcome: Bladder perforation      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 weeks

 Counts 2 0 not given
P-Value
Outcome: subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 years

 Percentage 98 80 .03
N Analyzed 61 60
P-Value
Outcome: objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

 Percentage 95 71 .01
Counts 56 40
P-Value
Outcome: objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 years

 Percentage 75 59 .05
Counts 43 33
P-Value
Outcome: de novo urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

 Percentage 17 11 no diff
Counts 10 7
N Analyzed 61 60
P-Value
Outcome: need for anticholinergic      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 years

 Percentage .03
Counts
N Analyzed
P-Value
Outcome: sense of incomplete voiding      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 years

 Percentage .41
Counts
N Analyzed


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling obturator
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2 Retropubic synthetic
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Name SSISS
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Study Country Sweden
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Sling Category Retropubic synthetic
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Minisling H (obturator)
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Multicenter? Yes
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Adverse Event Ascertainment Unclear/Not reported
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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) industry had no input into results
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Results & Comparisons


Results Data
P-Value
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 days

 Counts 58 50 0.0001
range 42-94 27-95
P-Value
Outcome: surgery time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 days

 Counts 22 13 <0.0001
range 13-36 7-25
P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 days

 Percentage 63 52 0.41
P-Value
Outcome: Bladder perforation      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 weeks

 Counts 2 0 not given
P-Value
Outcome: subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 years

 Percentage 98 80 .03
N Analyzed 61 60
P-Value
Outcome: objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

 Percentage 95 71 .01
Counts 56 40
P-Value
Outcome: objective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 years

 Percentage 75 59 .05
Counts 43 33
P-Value
Outcome: de novo urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure ERROR vs. ERROR


1 years

 Percentage 17 11 no diff
Counts 10 7
N Analyzed 61 60
P-Value
Outcome: need for anticholinergic      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 years

 Percentage .03
Counts
N Analyzed
P-Value
Outcome: sense of incomplete voiding      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-Secur H Minisling obturator Retropubic synthetic Comparison Measure TVT vs. TVT-Secur H


1 years

 Percentage .41
Counts
N Analyzed

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 Return to OR bleeding 1 week in hospital yes not defined 1 62 not done
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Retropubic synthetic 1 week in hospital yes not defined 0 63 not done
Total
Minisling obturator Infection, UTI incl pyelo 1 yr after no not defined 11 60 .48
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Retropubic synthetic 1 yr after no not defined 14 60 .48
Total
Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue 1 yr after no not defined 3 not given
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Retropubic synthetic 1 yr after no not defined 2 not given
Total
Minisling obturator
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Retropubic synthetic
Total