This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



Study Title and Description

Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence.



Key Questions Addressed
1 Sling vs Comparator RCT outcomes (excluding AEs)
  • Comments Comments (
    0
    ) |
2 Sling Adverse Events
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence.
Author Liapis A., Bakas P., Giner M., Creatsas G.
Country 2nd Department of Obstetrics and Gynecology, Aretaieio Hospital, University of Athens, Athens, Greece.
Year 2006
Numbers Pubmed ID: 16707901
397 (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
  • Comments Comments (
    0
    ) |
2 TVT-O
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Country Greece
  • Comments Comments (
    0
    ) |
Outcome Categories Reported Objective SUI
  • Comments Comments (
    0
    ) |
Subjective SUI
  • Comments Comments (
    0
    ) |
Population (reason for surgery etc.) Symptomatic SUI
  • Comments Comments (
    0
    ) |
Urodynamic SUI
  • Comments Comments (
    0
    ) |
RCT Comparison Category Retropubic vs. Obturator
  • Comments Comments (
    0
    ) |
Multicenter No
  • Comments Comments (
    0
    ) |
Institution Type Academic hospital
  • Comments Comments (
    0
    ) |
Number of surgeons performing procedures 1
  • Comments Comments (
    0
    ) |
Surgeons' Training Not reported
  • Comments Comments (
    0
    ) |
Residents or fellows performing surgery? Unclear/Not reported
  • Comments Comments (
    0
    ) |
Study Quality (overall) C (poor)
  • Comments Comments (
    0
    ) |
Study Sponsor/Funding ... Other ... unknown
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question TVT TVT-O TVT TVT-O Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 46 43
  • Comments Comments (
    0
    ) |
Mean Age 53 52
  • Comments Comments (
    0
    ) |
Post-Op Follow-Up Interval (Maximum) 1yr 1yr
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective- Cure      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 46 43
Counts 89% 90%
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI objective – IMPROVED      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 46 43
Counts 6.5% 7.6%
Standard Deviation
NS


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective - FAILURE      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 46 43
Counts 4.3% 2.5%
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective cure      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 46 43
Counts 34 N 43 N
Standard Deviation
NS


0 years

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


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective failure      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 46 43
Counts 2 N 3 N
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
Outcome: Time in hospital 1d      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 46 43
Counts 42 41
Standard Deviation
NS


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Time in hospital 2d      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
Counts
Standard Deviation


0 years

N Enrolled 46 43
Counts 3 2
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Time in hospital >3d      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 46 43
Counts 1 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
Outcome: Post op Detrusor instability      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 46 43
Counts 8.6% 9.3%
Standard Deviation
not given


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: De novo 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 46 43
Counts 10.8% 13.9%
Standard Deviation
not given


1 years

N Enrolled
Counts
Standard Deviation
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 TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 46 43
Mean 1.0 .9
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 TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 46 43
Mean 26.7min 17.4min
Standard Deviation
<.001


1 years

N Analyzed
Mean
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 TVT
  • Comments Comments (
    0
    ) |
2 TVT-O
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
  • Comments Comments (
    0
    ) |
Study Country Greece
  • Comments Comments (
    0
    ) |
Sling Category ... Other ... retropubic synthetic and transobturator synthetic
  • Comments Comments (
    0
    ) |
Multicenter? No
  • Comments Comments (
    0
    ) |
Institution Type Academic hospital
  • Comments Comments (
    0
    ) |
No. of Surgeons Performing the Procedures 1
  • Comments Comments (
    0
    ) |
Surgeons' Training Not reported
  • Comments Comments (
    0
    ) |
Residents or Fellows Performing the Surgery? Unclear/Not reported
  • Comments Comments (
    0
    ) |
Adverse Event Ascertainment Passive
  • Comments Comments (
    0
    ) |
Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
  • Comments Comments (
    0
    ) |
Was a data safety monitoring board used? No / Not reported
  • Comments Comments (
    0
    ) |
Study Sponsor/Funding Not reported
  • Comments Comments (
    0
    ) |




Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective- Cure      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 46 43
Counts 89% 90%
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI objective – IMPROVED      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 46 43
Counts 6.5% 7.6%
Standard Deviation
NS


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective - FAILURE      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 46 43
Counts 4.3% 2.5%
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective cure      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 46 43
Counts 34 N 43 N
Standard Deviation
NS


0 years

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


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: SUI subjective failure      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 46 43
Counts 2 N 3 N
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
Outcome: Time in hospital 1d      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 46 43
Counts 42 41
Standard Deviation
NS


1 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Time in hospital 2d      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
Counts
Standard Deviation


0 years

N Enrolled 46 43
Counts 3 2
Standard Deviation
NS
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Time in hospital >3d      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 46 43
Counts 1 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
Outcome: Post op Detrusor instability      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 46 43
Counts 8.6% 9.3%
Standard Deviation
not given


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: De novo 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 46 43
Counts 10.8% 13.9%
Standard Deviation
not given


1 years

N Enrolled
Counts
Standard Deviation
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 TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


1 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 46 43
Mean 1.0 .9
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 TVT-O TVT TVT-O Comparison Measure TVT vs. TVT-O


0 years

N Analyzed 46 43
Mean 26.7min 17.4min
Standard Deviation
<.001


1 years

N Analyzed
Mean
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 Vaginal erosion (required excision of tape) 1 46 ---
  • Comments Comments (
    0
    ) |
TVT-O 0 43
Total
TVT Organ injury in OR (urethra, bladder, bowel) bladder perforation 3 46 ---
  • Comments Comments (
    0
    ) |
TVT-O 0 43
Total
TVT Retention requiring catheter Cath x 10 days 1 46 ---
  • Comments Comments (
    0
    ) |
TVT-O 0 43
Total
TVT hemtoma space of Reitzius 0 46
  • Comments Comments (
    0
    ) |
TVT-O 0 43
Total
TVT Retention >100 mL 4 46
  • Comments Comments (
    0
    ) |
TVT-O 0 43
Total
TVT Req vag pack x 24 hr 1 46
  • Comments Comments (
    0
    ) |
TVT-O 0 43
Total
TVT
  • Comments Comments (
    0
    ) |
TVT-O
Total