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

Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: 1 yr follow-up



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 Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: 1 yr follow-up
Author Tommaselli, DiCarlo, Gargano, Formisano, Scala, Nappi
Country
Year 2010
Numbers Pubmed ID: 20502877
2575 (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-O
  • Comments Comments (
    0
    ) |
2 TVT-Secur H
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Country Italy
  • Comments Comments (
    0
    ) |
Outcome Categories Reported Objective SUI
  • Comments Comments (
    0
    ) |
Subjective SUI
  • Comments Comments (
    0
    ) |
Quality of life
  • Comments Comments (
    0
    ) |
OR outcomes/complications (not "AEs")
  • Comments Comments (
    0
    ) |
Population (reason for surgery etc.) Symptomatic SUI
  • Comments Comments (
    0
    ) |
Urodynamic SUI
  • Comments Comments (
    0
    ) |
RCT Comparison Category Minisling vs. Other
  • 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) B (fair)
  • Comments Comments (
    0
    ) |
Overall Study Notes I believe there is some methodological flaws that make this randomized clinical trial not getting A. No concern, lost to follow up at one year were = clearly outlined , not interestingly excluded totally from the analysis, even excluded from the baseline characteristics table which is not the norm (9 patients out of 84 patients met the criteria and were randomized to receive the treatments 4 out of 42 in the TVT-O & 5 out of 42 in the TVT secur) . Women lost to f/u because they did not complete the follow-up at 1 year. They were not included in the analysis – which, hence, was not done with intention to treat. Power Not reported; this is important as there were no significant differences which can be due to smaller sample. no flow diagram but, the flow of patients was clear 128 were evaluated 94 met the inclusion criteria of the study and 84 signed the consent form and were randomized. They were randomized using a table of random numbers with concealment that was broken at the day of surgery to the surgeon and to the patient after surgery.
  • Comments Comments (
    0
    ) |
Study Sponsor/Funding ... Other ... not reported
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 42 42
  • Comments Comments (
    0
    ) |
Mean Age 58.2 57.8
  • Comments Comments (
    0
    ) |
Post-Op Follow-Up Interval (Maximum) 12 mos 12 mos
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: operation time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


0 days

N Enrolled 38 37
Counts 11.3 7.1 <0.05
Standard Deviation 2.9 2.1
Statistical Test: P-Value
Outcome: Objective SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


12 months

N Enrolled 38 37
Counts 31 31 no differences noted
Percentage 81.6 83.8
Statistical Test: P-Value
Outcome: EBL "moderate"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


0 days

N Enrolled 38 37
Counts 5 8 "no differences in qualitative blood loss"
Percentage 13.1 21.6
Outcome: Hospitalization length      Population: All Participants
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator


1 days

N Enrolled
Counts all went home next day all went home next day
Percentage
Outcome: de novo urgency      Population: All Participants
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator


12 months

N Enrolled 38 37
Counts 1 2
Percentage 2.6 5.4
Outcome: urinary retention      Population: All Participants
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator


12 months

N Enrolled 38 37
Counts 2 0
Percentage 5.2 0
Statistical Test: P-Value
Outcome: first void      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


1 days

N Enrolled 38 37
Counts 93.4 65.8 <0.05
Standard Deviation 32.1 18.5
N Enrolled Mean Difference Standard Deviation
Outcome: Satisfaction with procedure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


12 months

N Analyzed 38 37
Mean 7.9 8.5 no difference
Standard Deviation 3.2 3.6
N Enrolled P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure ERROR vs. ERROR


1 days

N Analyzed 38 37
Mean 4.5 2.1 reported as <0.05 and as =0.05 in different places
Standard Deviation 2.3 1.1
N Enrolled Mean Difference Standard Deviation
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


1 months

N Analyzed 38 37
Mean 1.5 0 reported as <0.05 and as =0.05 in different places
Standard Deviation 0.5 0
N Enrolled Mean Difference Standard Deviation
Outcome: Incontinence impact      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure ERROR vs. ERROR


12 months

N Analyzed
Mean unclear unclear no difference
Standard Deviation
text figure not labelled clearly figure not labelled clearly
Outcome: QOL      Population: All Participants
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator


12 months

N Analyzed
Mean
Standard Deviation
text see table in paper for subscales - no difference between groups see table in paper for subscales - no difference between groups


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Transobturator synthetic
  • Comments Comments (
    0
    ) |
2 Minisling obturator
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
  • Comments Comments (
    0
    ) |
Study Country Italy
  • Comments Comments (
    0
    ) |
Sling Category Obturator synthetic
  • Comments Comments (
    0
    ) |
Minisling H (obturator)
  • Comments Comments (
    0
    ) |
Adverse Event Ascertainment Unclear/Not reported
  • 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
    ) |




Results & Comparisons


Results Data
Statistical Test: P-Value
Outcome: operation time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


0 days

N Enrolled 38 37
Counts 11.3 7.1 <0.05
Standard Deviation 2.9 2.1
Statistical Test: P-Value
Outcome: Objective SUI cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


12 months

N Enrolled 38 37
Counts 31 31 no differences noted
Percentage 81.6 83.8
Statistical Test: P-Value
Outcome: EBL "moderate"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


0 days

N Enrolled 38 37
Counts 5 8 "no differences in qualitative blood loss"
Percentage 13.1 21.6
Outcome: Hospitalization length      Population: All Participants
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator


1 days

N Enrolled
Counts all went home next day all went home next day
Percentage
Outcome: de novo urgency      Population: All Participants
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator


12 months

N Enrolled 38 37
Counts 1 2
Percentage 2.6 5.4
Outcome: urinary retention      Population: All Participants
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator


12 months

N Enrolled 38 37
Counts 2 0
Percentage 5.2 0
Statistical Test: P-Value
Outcome: first void      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


1 days

N Enrolled 38 37
Counts 93.4 65.8 <0.05
Standard Deviation 32.1 18.5
N Enrolled Mean Difference Standard Deviation
Outcome: Satisfaction with procedure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


12 months

N Analyzed 38 37
Mean 7.9 8.5 no difference
Standard Deviation 3.2 3.6
N Enrolled P-Value
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure ERROR vs. ERROR


1 days

N Analyzed 38 37
Mean 4.5 2.1 reported as <0.05 and as =0.05 in different places
Standard Deviation 2.3 1.1
N Enrolled Mean Difference Standard Deviation
Outcome: Pain      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure TVT-O vs. TVT-Secur H


1 months

N Analyzed 38 37
Mean 1.5 0 reported as <0.05 and as =0.05 in different places
Standard Deviation 0.5 0
N Enrolled Mean Difference Standard Deviation
Outcome: Incontinence impact      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator Comparison Measure ERROR vs. ERROR


12 months

N Analyzed
Mean unclear unclear no difference
Standard Deviation
text figure not labelled clearly figure not labelled clearly
Outcome: QOL      Population: All Participants
Time Point Measure TVT-O TVT-Secur H Transobturator synthetic Minisling obturator


12 months

N Analyzed
Mean
Standard Deviation
text see table in paper for subscales - no difference between groups see table in paper for subscales - no difference between groups

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
Transobturator synthetic Pain, groin (new or different after surgery) leg pain 12 mos after discharge no - "transient" not done 3 38 not given not given
  • Comments Comments (
    0
    ) |
Minisling obturator 12 mos after discharge 0 37 not given not given
Total
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue vaginal 12 mos after discharge sometimes not done 0 38 not given not given
  • Comments Comments (
    0
    ) |
Minisling obturator 12 mos after discharge 1 37 not given not given
Total
Transobturator synthetic
  • Comments Comments (
    0
    ) |
Minisling obturator
Total