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Study Title and Description

One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial.



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 follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial.
Author Zullo MA., Plotti F., Calcagno M., Marullo E., Palaia I., Bellati F., Basile S., Muzii L., Angioli R., Panici PB.
Country Department of Obstetrics and Gynecology, University of Rome Campus Bio-medico, Via Longoni 83, 00155 Rome, Italy. m.zullo@unicampus.it
Year 2007
Numbers Pubmed ID: 17110021
427 (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-O
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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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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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RCT Comparison Category Retropubic vs. Obturator
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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 ... 2
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Surgeons' Training ... Other ... unknown
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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 The paper is supposedly powered to identify a difference in complication rate, but it’s not clear which complications get included in this composite. It appears there are no significant differences in any complication. This could definitely be due to too small a sample size (finding a difference of 39% vs 7% was too ambitious). The authors still conclude the TVT-O "had a…lower overall perioperative complication rate." This is misleading.
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Study Sponsor/Funding ... Other ... unknown
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Baseline Characteristics
Question TVT TVT-O TVT TVT-O Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 35 37
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Mean Age 52.8 53.4
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Post-Op Follow-Up Interval (Maximum) 1yr 1yr
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI objective      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Enrolled 35 37
Counts 32 33
Standard Deviation
NS


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: UDS finding of DO      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Enrolled 35 37
Counts 0 0
Standard Deviation
NS


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Enrolled 35 37
Counts 2 0
Standard Deviation
NS


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 35 37
Counts 3 0
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Nocturia      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Enrolled 35 37
Counts
Standard Deviation 0 0
NS


0 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: SUI subjective VAS      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Analyzed 35 37
Mean 1.1 .9
Standard Deviation
NS


0 years

N Analyzed 35 37
Mean 8.6 8.2
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. ERROR


0 years

N Analyzed 35 37
Mean 38.9 42.5
Standard Deviation
NS


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 35 37
Mean 28.3 16.9
Standard Deviation
<.001
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 35 37
Mean 1.2 1.1
Standard Deviation
NS


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time to return to normal activities      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 35 37
Mean 2.1 2.0
Standard Deviation
NS
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Cotton swab test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 35 37
Mean 78.4 72.6
Standard Deviation
not given


1 years

N Analyzed 35 37
Mean 34.6 36.8
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. ERROR


1 years

N Analyzed
Mean 13 13
Standard Deviation
NS


0 years

N Analyzed
Mean 13 11
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 TVT
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2 TVT-O
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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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Obturator synthetic
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Multicenter? Yes
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Institution Type Unclear/Not reported
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No. of Surgeons Performing the Procedures ... Other ... 2
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Surgeons' Training ... Other ... unclear
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Active
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Was the Clavien-Dindo Classification of Surgical Complications system used? Yes
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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 P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI objective      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Enrolled 35 37
Counts 32 33
Standard Deviation
NS


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: UDS finding of DO      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Enrolled 35 37
Counts 0 0
Standard Deviation
NS


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Enrolled 35 37
Counts 2 0
Standard Deviation
NS


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 35 37
Counts 3 0
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Nocturia      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Enrolled 35 37
Counts
Standard Deviation 0 0
NS


0 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: SUI subjective VAS      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Analyzed 35 37
Mean 1.1 .9
Standard Deviation
NS


0 years

N Analyzed 35 37
Mean 8.6 8.2
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. ERROR


0 years

N Analyzed 35 37
Mean 38.9 42.5
Standard Deviation
NS


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 35 37
Mean 28.3 16.9
Standard Deviation
<.001
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 35 37
Mean 1.2 1.1
Standard Deviation
NS


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time to return to normal activities      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 35 37
Mean 2.1 2.0
Standard Deviation
NS
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Cotton swab test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 35 37
Mean 78.4 72.6
Standard Deviation
not given


1 years

N Analyzed 35 37
Mean 34.6 36.8
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: PVR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TVT-O TVT TVT-O Comparison Measure TVT vs. ERROR


1 years

N Analyzed
Mean 13 13
Standard Deviation
NS


0 years

N Analyzed
Mean 13 11
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
TVT Mesh erosion/extrusion/exposure/granulation tissue Tape erosion, at 12mo 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT Pain, unspecified area (new or different after surgery) "Severe Pain" (requires analgesia >1wk postop) 1y 0 35 ns
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TVT-O 1y 1 37
Total
TVT Return to OR (see Dindo Grade IIIb complication below) 1y 1 35 ns
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TVT-O 1y 0 37
Total
TVT Infection, UTI ND 1y 2 35 ns
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TVT-O 1y 1 37
Total
TVT Infection, surgical site/wound ND 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT Organ injury in OR (urethra, bladder, bowel) Bladder injury 1y 2 35 ns
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TVT-O 1y 0 37
Total
TVT DVT DVT/PE 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT Transfusion post-op 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT retention requiring catheter Duration of catheter-ization >7d 1y 1 35 ns
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TVT-O 1y 0 37
Total
TVT vascular injury 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT Death 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT bowel injury 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT neurologic injury 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT vaginal perforation 1y 1 35 ns
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TVT-O 1y 0 37
Total
TVT retropubic hematoma 1y 1 35 ns
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TVT-O 1y ND 37
Total
TVT obturator hematoma 1y ND 35 ns
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TVT-O 1y 0 37
Total
TVT fever 1y 2 35 ns
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TVT-O 1y 0 37
Total
TVT Dindo Grade I 1y 5 35 ns
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TVT-O 1y 3 37
Total
TVT Dindo Grade II 1y 2 35 ns
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TVT-O 1y 1 37
Total
TVT Dindo Grade IIIa 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT Dindo Grade IIIb (this was one case of surgical revision for retropubic hematoma) 1y 1 35 ns
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TVT-O 1y 0 37
Total
TVT Dindo Grade IVa 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT Dindo Grade IVb 1y 0 35 ns
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TVT-O 1y 0 37
Total
TVT
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TVT-O
Total
TVT
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TVT-O
Total