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Study Title and Description

A randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult 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 comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult stress urinary incontinence.
Author Meschia M., Pifarotti P., Spennacchio M., Buonaguidi A., Gattei U., Somigliana E.
Country Department of Obstetrics and Gynecology, Urogynecology Unit, University of Milan, Milano, Italy. m.meschia@libero.it
Year 2004
Numbers Pubmed ID: 15041988
8303 (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 TVT performed by Ulmsten. The TVT procedure was peformed using Gynecare TVT. Midurethral placement. Small sagittal vaginal incision. This was done PRIOR to repaire of the prolapse. Tape adjusted AFTER prolapse repair. Patient was awakened to cough with a 300cc bladder fill.
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2 Endopelvic fascial plication Endopelvic fascia plication was performed at the level of the urethrovesical jnction and was carried out with the use of 2-0 permanent braided polyester sutures.
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Italy
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Outcome Categories Reported Objective SUI
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Subjective SUI
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Population (reason for surgery etc.) Symptomatic SUI
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Other ... Also, occult SUI revealed with reduction bladder fill
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RCT Comparison Category Retropubic vs. Other
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Other comparison ... TVT vs. fascia plication
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures Not reported
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Surgeons' Training General
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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 ... not clear
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Baseline Characteristics
Question TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 25 25 50
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Mean Age 65yr
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Post-Op Follow-Up Interval (Maximum) 12mo 12mo
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective-Positive cough stress      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 25 25
Counts 2 11
Standard Deviation
<.01
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


1 years

N Enrolled 25 25
Counts 1 9
Standard Deviation
.01


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: De novo UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 25 25
Counts 3 1
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Retreatment for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 25 25
Counts 0 3
Standard Deviation
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N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 25 25
Mean 188 177
Standard Deviation
NS
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


0 years

N Analyzed 25 25
Mean 131 112
Standard Deviation
<.001


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 25 25
Mean 6.4d 6.1d
Standard Deviation
NS
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: drop in Hgb      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 25 25
Mean 1.8cc 1cc
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT
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2 Endopelvic fascial plication Endopelvic fascia plication was performed at the level of the urethrovesical jnction and was carried out with the use of 2-0 permanent braided polyester sutures.
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Italy
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Sling Category Retropubic synthetic
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Multicenter? No
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training General
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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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 Not reported
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective-Positive cough stress      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 25 25
Counts 2 11
Standard Deviation
<.01
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


1 years

N Enrolled 25 25
Counts 1 9
Standard Deviation
.01


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: De novo UUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 25 25
Counts 3 1
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Retreatment for SUI      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 25 25
Counts 0 3
Standard Deviation
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N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 25 25
Mean 188 177
Standard Deviation
NS
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


0 years

N Analyzed 25 25
Mean 131 112
Standard Deviation
<.001


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure TVT vs. Endopelvic fascial plication


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 25 25
Mean 6.4d 6.1d
Standard Deviation
NS
N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value
Outcome: drop in Hgb      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Endopelvic fascial plication Retropubic synthetic Endopelvic fascial plication Comparison Measure


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 25 25
Mean 1.8cc 1cc
Standard Deviation

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 Infection, UTI unclear post op after discharge 3 25
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Endopelvic fascial plication 1 25
Total
Retropubic synthetic Retention requiring catheter delayed voiding 2 25
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Endopelvic fascial plication 2 25
Total
Retropubic synthetic Bladder perforation
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Endopelvic fascial plication 1 25
Total