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Study Title and Description

A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women.



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 randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women.
Author Guerrero KL., Emery SJ., Wareham K., Ismail S., Watkins A., Lucas MG.
Country Department of Urogynaecology, Southern General Hospital, Glasgow, UK. karen.guerrero@ggc.scot.nhs.uk
Year 2010
Numbers Pubmed ID: 20939862
5626 (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 PVS, fascial
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3 PVS, pelvicol
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Design Details
Question... Follow Up Answer Follow-up Answer
Trial Name n/a
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Country UK
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Outcome Categories Reported 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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RCT Comparison Category Pubovaginal sling vs. Other
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Retropubic 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 Not reported
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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) B (fair)
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Overall Study Notes Randmozed by site/surgeon. Patients blinded other than to presence of incision. Nurse collecting data blinded. All slings placed midurethrally. Met power for TVT/fascial slings and stopped pelvicol arm early due to independent interim analysis showing poor success rates. Analysis by ITT.
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Study Sponsor/Funding Industry
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Academia
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Baseline Characteristics
Question TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 72 79 50 201
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Mean Age 54 52 52 50s
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Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos 12 mos
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: SUI outcomes      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR PVS, pelvicol vs. PVS, fascial TVT vs. PVS, fascial


1 years

N Enrolled 72 79 50 Kruskall Wallis Kruskall Wallis Kruskall Wallis
Counts 38 32 10 <0.001 0.042 0.288
Percentage 53 41 20
Statistical Test: P-Value
Outcome: SUI outcomes      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure TVT vs. PVS, pelvicol PVS, pelvicol vs. PVS, fascial TVT vs. PVS, fascial


1 years

N Enrolled 72 79 50 Kruskall Wallis Kruskall Wallis Kruskall Wallis
Counts 64 60 28 0.0001 0.048 0.097
Percentage 89 76 56
Statistical Test: P-Value
Outcome: BFLUTS - daytime frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 21 35 55 TVT and fascial better than pelvicol (<0.001)
Statistical Test: P-Value
Outcome: BFLUTS - urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 40 44 74 TVT and fascial better than pelvicol (<0.001)
Statistical Test: P-Value
Outcome: BFLUTS - stress incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 21 23 58 TVT and fascial sling better than Pelvicol P < 0.001
Statistical Test: P-Value
Outcome: BFLUTS - frequency of incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 37 40 66 TVT and fascial better than pelvicol (<0.001)
Statistical Test: P-Value
Outcome: BFLUTS - unexplained incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 23 19 50 TVT and fascial better than pelvicol (<0.001)
Statistical Test: P-Value
Outcome: BFLUTS - quantity urine loss      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts
Percentage NA NA NA
Outcome: ISC rate      Population: All Participants
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS


1 years

Counts 0 0 0
Percentage 0 0 0
Statistical Test: P-Value
Outcome: reoperation for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts 0 0 9 Kruskall Wallis
Percentage 0 0 19.5 <0.0001
N Enrolled P-Value Statistical Test:
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure All Arms (ANOVA)


1 weeks

N Analyzed 72 79 50 201
Mean 35 54 36 <0.001
Range 14-120 25-140 17-70
N Enrolled P-Value Statistical Test:
Outcome: Hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure All Arms (ANOVA)


1 weeks

N Analyzed 72 79 50 201
Mean 2 4 4 <0.001
Range 1-10 1-22 1-12
N Enrolled P-Value Statistical Test:
Outcome: EuroQOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure PVS, fascial vs. PVS, fascial


1 years

N Analyzed no diff in improvement between groups
Mean not given/not improved not given/not improved 0.919 <0.05
Range Wilcoxon/Mann Whitney U test


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Fascial PVS autologous
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2 Retropubic synthetic TVT
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3 Xenograft PVS pelvicol
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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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Pubovaginal (bladder neck)
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Other ... Pubovaginal fascial and pubovaginal fascial
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Adverse Event Ascertainment Passive
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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? Yes
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Study Sponsor/Funding Industry
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Academia
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Comments (overall study) Study reviewed multiple times by an independent board - recommended stopping Pelvicol arm early. Not clearly stated that they were reviewing AEs but I think it's close enough - obviously there was independent oversight.
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Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: SUI outcomes      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR PVS, pelvicol vs. PVS, fascial TVT vs. PVS, fascial


1 years

N Enrolled 72 79 50 Kruskall Wallis Kruskall Wallis Kruskall Wallis
Counts 38 32 10 <0.001 0.042 0.288
Percentage 53 41 20
Statistical Test: P-Value
Outcome: SUI outcomes      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure TVT vs. PVS, pelvicol PVS, pelvicol vs. PVS, fascial TVT vs. PVS, fascial


1 years

N Enrolled 72 79 50 Kruskall Wallis Kruskall Wallis Kruskall Wallis
Counts 64 60 28 0.0001 0.048 0.097
Percentage 89 76 56
Statistical Test: P-Value
Outcome: BFLUTS - daytime frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 21 35 55 TVT and fascial better than pelvicol (<0.001)
Statistical Test: P-Value
Outcome: BFLUTS - urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 40 44 74 TVT and fascial better than pelvicol (<0.001)
Statistical Test: P-Value
Outcome: BFLUTS - stress incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 21 23 58 TVT and fascial sling better than Pelvicol P < 0.001
Statistical Test: P-Value
Outcome: BFLUTS - frequency of incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 37 40 66 TVT and fascial better than pelvicol (<0.001)
Statistical Test: P-Value
Outcome: BFLUTS - unexplained incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts Kruskall Wallis
Percentage 23 19 50 TVT and fascial better than pelvicol (<0.001)
Statistical Test: P-Value
Outcome: BFLUTS - quantity urine loss      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts
Percentage NA NA NA
Outcome: ISC rate      Population: All Participants
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS


1 years

Counts 0 0 0
Percentage 0 0 0
Statistical Test: P-Value
Outcome: reoperation for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure ERROR vs. ERROR


1 years

Counts 0 0 9 Kruskall Wallis
Percentage 0 0 19.5 <0.0001
N Enrolled P-Value Statistical Test:
Outcome: OR time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure All Arms (ANOVA)


1 weeks

N Analyzed 72 79 50 201
Mean 35 54 36 <0.001
Range 14-120 25-140 17-70
N Enrolled P-Value Statistical Test:
Outcome: Hospital stay      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure All Arms (ANOVA)


1 weeks

N Analyzed 72 79 50 201
Mean 2 4 4 <0.001
Range 1-10 1-22 1-12
N Enrolled P-Value Statistical Test:
Outcome: EuroQOL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT PVS, fascial PVS, pelvicol Fascial PVS Retropubic synthetic Xenograft PVS Comparison Measure PVS, fascial vs. PVS, fascial


1 years

N Analyzed no diff in improvement between groups
Mean not given/not improved not given/not improved 0.919 <0.05
Range Wilcoxon/Mann Whitney U test

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
Fascial PVS Organ injury in OR (urethra, bladder, bowel) Bladder 12 mos in OR no not defined 2 79 0.6386
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Retropubic synthetic 12 mos in OR no not defined 4 72 0.6386
Xenograft PVS 12 mos in OR no not defined 1 50 0.6386
Total