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

Untitled



Key Questions Addressed
2 Sling Adverse Events
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title
Author Tincello DG, Botha T, Grier D, Jones P, Subramaina D, Urquhart C, Kirkemo A, Khandwala S
Country University of Leicester and TVT worldwide registry
Year 2011
Numbers Pubmed ID: 22014817
831 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT
  • Comments Comments (
    0
    ) |
2 Minisling retropubic TVT secur
  • Comments Comments (
    0
    ) |
3 Transobturator synthetic TVT-O
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Prospective nonrandom (2+ slings analyzed separately)
  • Comments Comments (
    0
    ) |
Study Name The TVT Worldwide Observational Registry for Long-Term Data: Safety and Efficacy of Suburethral Sling Insertion Approaches for Stress Urinary Incontinence in Women
  • Comments Comments (
    0
    ) |
Study Country US
  • Comments Comments (
    0
    ) |
Austria
  • Comments Comments (
    0
    ) |
Canada
  • Comments Comments (
    0
    ) |
Germany
  • Comments Comments (
    0
    ) |
South Korea
  • Comments Comments (
    0
    ) |
UK
  • Comments Comments (
    0
    ) |
Other ... Singapore, South Africa
  • Comments Comments (
    0
    ) |
Sling Category Retropubic synthetic
  • Comments Comments (
    0
    ) |
Obturator synthetic
  • Comments Comments (
    0
    ) |
Minisling H (obturator)
  • Comments Comments (
    0
    ) |
Minsling U (retropubic)
  • Comments Comments (
    0
    ) |
Multicenter? Yes
  • Comments Comments (
    0
    ) |
Institution Type Unclear/Not reported
  • Comments Comments (
    0
    ) |
No. of Surgeons Performing the Procedures Unclear/Not reported
  • 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 Active
  • 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 Industry
  • Comments Comments (
    0
    ) |
Comments (overall study) Study reporting of AEs were weak; they did track complications periop and post op; but did not list time point for post op complications (only listed patients were followed up for 1 year but had high attrition rate); also had a line in table for "other" that were not specifically defined in the text; strengths are that this was large numbers of patients undergoing TVT, TVT secur and TVT-O that were followed prospectively for outcomes/AEs; types of TVT Secur were not separated out for complications (ie, both H and U positions reported in aggregate)
  • Comments Comments (
    0
    ) |




Results & Comparisons

No Results found.
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 Mesh erosion/extrusion/exposure/granulation tissue listed as sling erosion up to 1 year post op after d/c not listed not listed 7 469 not listed 0.4998
  • Comments Comments (
    0
    ) |
Minisling retropubic up to 1 year post op after d/c 8 677 not listed
Transobturator synthetic up to 1 year post op after d/c 1 252 not listed
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) bladder perforation in OR in hospital not listed not listed 10 469 not listed 0.0012
  • Comments Comments (
    0
    ) |
Minisling retropubic in OR in hospital 1 677 not listed
Transobturator synthetic in OR in hospital 1 252 not listed
Total
Retropubic synthetic hematoma in OR in hospital not listed not listed 2 469 not listed 1.000
  • Comments Comments (
    0
    ) |
Minisling retropubic in OR in hospital 4 677
Transobturator synthetic in OR in hospital 1 252
Total
Retropubic synthetic bleeding >200ml in OR in hospital not listed not listed 1 469 not listed 0.3347
  • Comments Comments (
    0
    ) |
Minisling retropubic in OR in hospital 5 677 not listed
Transobturator synthetic in OR in hospital 0 252 not listed
Total
Retropubic synthetic Device injury not further defined - possibly lateral sulcus injury (extrapolating from text) in OR in hospital not listed not listed 0 469 not listed 0.0978
  • Comments Comments (
    0
    ) |
Minisling retropubic 5 677 not listed
Transobturator synthetic 0 252 not listed
Total
Retropubic synthetic device malfunction not further defined in OR in hospital not listed not listed 0 469 not listed 1.000
  • Comments Comments (
    0
    ) |
Minisling retropubic 1 677
Transobturator synthetic 0 252
Total
Retropubic synthetic Infection, UTI post op not listed not listed not listed 9 469 not listed 0.2098
  • Comments Comments (
    0
    ) |
Minisling retropubic 5 677
Transobturator synthetic 2 252
Total
Retropubic synthetic urinary retention Did not specify if it lead to return to OR post op not listed not listed not listed 10 469 not listed 0.0082
  • Comments Comments (
    0
    ) |
Minisling retropubic 2 677
Transobturator synthetic 2 252
Total
Retropubic synthetic de novo OAB criteria for this not given post op after discharge not listed not listed 14 469 not listed 0.0083
  • Comments Comments (
    0
    ) |
Minisling retropubic 15 677
Transobturator synthetic 0 252
Total
Retropubic synthetic voiding dysfunction not further defined post op after discharge not listed not listed 10 469 not listed 0.0942
  • Comments Comments (
    0
    ) |
Minisling retropubic 6 677
Transobturator synthetic 1 252
Total
Retropubic synthetic Pain, groin (new or different after surgery) not further defined post op after discharge not listed not listed 2 469 not listed 0.0041
  • Comments Comments (
    0
    ) |
Minisling retropubic 0 677
Transobturator synthetic 4 252
Total
Retropubic synthetic Infection, surgical site/wound not further defined post op not listed not listed not listed 3 469 not listed 0.3338
  • Comments Comments (
    0
    ) |
Minisling retropubic 1 677
Transobturator synthetic 1 252
Total
Retropubic synthetic mixed UI not further defined post op after discharge not listed not listed 1 469 not listed 0.7638
  • Comments Comments (
    0
    ) |
Minisling retropubic 1 677
Transobturator synthetic 1 252
Total
Retropubic synthetic Pain, other (new or different after surgery) abdominal pain post op after discharge not listed not listed 0 469 not listed 0.6748
  • Comments Comments (
    0
    ) |
Minisling retropubic 2 677
Transobturator synthetic 0 252
Total
Retropubic synthetic dyspareunia post op after discharge not listed not listed 0 469 not listed 0.1803
  • Comments Comments (
    0
    ) |
Minisling retropubic 0 677
Transobturator synthetic 1 252
Total
Retropubic synthetic worsening urge incontinence not further defined post op after discharge not listed not listed 1 469 not listed 0.5157
  • Comments Comments (
    0
    ) |
Minisling retropubic 0 677
Transobturator synthetic 0 252
Total
Retropubic synthetic other AEs not further defined post op after discharge not listed not listed 5 469 not listed 0.0831
  • Comments Comments (
    0
    ) |
Minisling retropubic 1 677
Transobturator synthetic 1 252
Total