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

A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female 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 A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female stress urinary incontinence.
Author Téllez Martínez-Fornés M., Fernández Pérez C., Fouz López C., Fernández Lucas C., Borrego Hernando J.
Country Urology Department, Severo Ochoa Hospital, Leganés, Madrid, Spain. migueltellez@hotmail.com
Year 2009
Numbers Pubmed ID: 20096179
980 (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 Burch
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Country Spain
  • 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
    ) |
Intrinsic sphincter deficiency
  • Comments Comments (
    0
    ) |
RCT Comparison Category Sling vs. Burch
  • Comments Comments (
    0
    ) |
Multicenter No
  • Comments Comments (
    0
    ) |
Institution Type Unclear/Not reported
  • Comments Comments (
    0
    ) |
Number of surgeons performing procedures ... Other ... at least 2 (2 Urologists did TVT, ? did Burch)
  • Comments Comments (
    0
    ) |
Surgeons' Training Urology
  • Comments Comments (
    0
    ) |
Residents or fellows performing surgery? Unclear/Not reported
  • Comments Comments (
    0
    ) |
Study Quality (overall) B (fair)
  • Comments Comments (
    0
    ) |
Study Sponsor/Funding ... Other ... Unclear
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question TVT Burch Retropubic synthetic Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 24 25
  • Comments Comments (
    0
    ) |
Mean Age 47.13 50.0
  • Comments Comments (
    0
    ) |
Post-Op Follow-Up Interval (Maximum) 3 yr 3 yr
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Positive 1hr pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


12 months

N Enrolled 23 24 0.97
Counts 1 1 0.96
Percentage 4.3 4.2 0.06
16.25


36 months

N Enrolled 21 23 0.55
Counts 3 2 0.57
Percentage 15 9.1 0.08
3.40
P-Value P-Value
Outcome: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


12 months

N Enrolled 23 24 0.19
Counts 14 16
Percentage 60.9 66.7


36 months

N Enrolled 21 23 0.19
Counts 14 16
Percentage 63.6 69.6
P-Value P-Value
Outcome: "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


12 months

N Enrolled 23 24 0.19
Counts 4 5
Percentage 17.4 20.8


36 months

N Enrolled 21 23 0.19
Counts 3 5
Percentage 13.6 21.7
P-Value P-Value
Outcome: "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


12 months

N Enrolled 23 24 0.19
Counts 5 3
Percentage 21.7 12.5


36 months

N Enrolled 21 23 0.19
Counts 5 2
Percentage 22.7 8.7
P-Value P-Value P-Value
Outcome: ISI score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 0.52
Mean 16.26 16.67
Standard Deviation 2.22 2.18


12 months

N Analyzed 23 24 NS
Mean 0.83 1.5
Standard Deviation ? ~3.5


36 months

N Analyzed 21 23 NS
Mean 1.0 1.8
Standard Deviation ~2.5 ~4.0
Within-Arm Comparisons
Comparison Measure TVT Burch Retropubic synthetic Burch
0 months vs. 12 months P-Value <0.05 <0.05
12 months vs. 36 months P-Value NS NS
P-Value P-Value P-Value
Outcome: IIQ score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 0.19
Median 4 7
25th Percentile 2 4
75th Percentile 8 9


12 months

N Analyzed 23 24 NS
Mean 0.2 0.67
Standard Deviation ~4.3 ~4.3


36 months

N Analyzed 21 23 NS
Mean 0.55 0.35
Standard Deviation ~4.8 ~4.3
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 <0.0001
Median 1 3
25th Percentile 1 3
75th Percentile 2 3
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 0.003
Mean 41.1 57.1
Standard Deviation 10.9 18.3
P-Value
Outcome: Analgesia # doses      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 <0.0001
Median 6 23.5
25th Percentile 2.8 18
75th Percentile 10.5 31.5
P-Value
Outcome: Cost      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 0.599
Mean 2231 2125
Standard Deviation 445.33 569.99


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
  • Comments Comments (
    0
    ) |
2 Burch Two #1 Ethibond on each side
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
  • Comments Comments (
    0
    ) |
Sling Category Retropubic synthetic
  • Comments Comments (
    0
    ) |
Other ... Burch
  • 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
    ) |
Study Sponsor/Funding Not reported
  • Comments Comments (
    0
    ) |




Results & Comparisons


Results Data
P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Positive 1hr pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


12 months

N Enrolled 23 24 0.97
Counts 1 1 0.96
Percentage 4.3 4.2 0.06
16.25


36 months

N Enrolled 21 23 0.55
Counts 3 2 0.57
Percentage 15 9.1 0.08
3.40
P-Value P-Value
Outcome: "Cure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


12 months

N Enrolled 23 24 0.19
Counts 14 16
Percentage 60.9 66.7


36 months

N Enrolled 21 23 0.19
Counts 14 16
Percentage 63.6 69.6
P-Value P-Value
Outcome: "Improvement"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


12 months

N Enrolled 23 24 0.19
Counts 4 5
Percentage 17.4 20.8


36 months

N Enrolled 21 23 0.19
Counts 3 5
Percentage 13.6 21.7
P-Value P-Value
Outcome: "Failure"      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


12 months

N Enrolled 23 24 0.19
Counts 5 3
Percentage 21.7 12.5


36 months

N Enrolled 21 23 0.19
Counts 5 2
Percentage 22.7 8.7
P-Value P-Value P-Value
Outcome: ISI score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 0.52
Mean 16.26 16.67
Standard Deviation 2.22 2.18


12 months

N Analyzed 23 24 NS
Mean 0.83 1.5
Standard Deviation ? ~3.5


36 months

N Analyzed 21 23 NS
Mean 1.0 1.8
Standard Deviation ~2.5 ~4.0
Within-Arm Comparisons
Comparison Measure TVT Burch Retropubic synthetic Burch
0 months vs. 12 months P-Value <0.05 <0.05
12 months vs. 36 months P-Value NS NS
P-Value P-Value P-Value
Outcome: IIQ score      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 0.19
Median 4 7
25th Percentile 2 4
75th Percentile 8 9


12 months

N Analyzed 23 24 NS
Mean 0.2 0.67
Standard Deviation ~4.3 ~4.3


36 months

N Analyzed 21 23 NS
Mean 0.55 0.35
Standard Deviation ~4.8 ~4.3
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 <0.0001
Median 1 3
25th Percentile 1 3
75th Percentile 2 3
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 0.003
Mean 41.1 57.1
Standard Deviation 10.9 18.3
P-Value
Outcome: Analgesia # doses      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 <0.0001
Median 6 23.5
25th Percentile 2.8 18
75th Percentile 10.5 31.5
P-Value
Outcome: Cost      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 months

N Analyzed 24 25 0.599
Mean 2231 2125
Standard Deviation 445.33 569.99

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 Organ injury in OR (urethra, bladder, bowel) Bladder lesion Intraop In-hospital ND ND 4 24 RR 4.17 (95% CI 0.5-34.6) 0.19
  • Comments Comments (
    0
    ) |
Burch Intraop In-hospital ND ND 1 25
Total
Retropubic synthetic Transfusion post-op Intraop In-hospital ND ND 0 24 ND NS
  • Comments Comments (
    0
    ) |
Burch Intraop In-hospital ND ND 0 25
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Urethral injury Intraop In-hospital ND ND 0 24 ND NS
  • Comments Comments (
    0
    ) |
Burch Intraop In-hospital ND ND 0 25
Total
Retropubic synthetic Infection, UTI Periop After discharge ND ND 1 23 ND 0.49
  • Comments Comments (
    0
    ) |
Burch Periop After discharge ND ND 0 24
Total
Retropubic synthetic Urinary retention (intervention not defined) Periop After discharge ND ND 5 23 RR 5.22 (95% CI 0.66-41.33) 1
  • Comments Comments (
    0
    ) |
Burch Periop After discharge ND ND 1 24
Total
Retropubic synthetic Infection, surgical site/wound Periop After discharge ND ND 3 23 RR 3.13 (95% CI 0.35-37.96) 0.35
  • Comments Comments (
    0
    ) |
Burch Periop After discharge ND ND 1 24
Total
Retropubic synthetic De novo urgency 12mo After discharge ND ND 7 23 RR 0.46 (.11-1.84) 0.26
  • Comments Comments (
    0
    ) |
Burch 12mo After discharge ND ND 4 24
Total
Retropubic synthetic De novo urgency 36mo After discharge ND ND 6 21 RR 0.69 (.18-2.73) 0.73
  • Comments Comments (
    0
    ) |
Burch 36mo After discharge ND ND 5 23
Total
Retropubic synthetic Obstruction (intervention not defined) 12mo After discharge ND ND 4 23 RR 0.21 (.02-2.01) 0.13
  • Comments Comments (
    0
    ) |
Burch 12mo After discharge ND ND 1 24
Total
Retropubic synthetic Obstruction (intervention not defined) 36mo After discharge ND ND 3 21 RR 0.29 (.03-3.01) 0.35
  • Comments Comments (
    0
    ) |
Burch 36mo After discharge ND ND 1 23
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue Vaginal - required reoperation <36mo After discharge ND ND 1 21 ND ND
  • Comments Comments (
    0
    ) |
Burch <36mo After discharge ND ND 0 23
Total