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

Suburethral sling materials: Best outcome with autologous tissue



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

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Suburethral sling materials: Best outcome with autologous tissue
Author Simsiman AJ, Powell CR, Stratford RR, Menefee SA.
Country --
Year 2005
Numbers Pubmed ID: 16325625
15 (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 Fascial PVS Rectus or fascia lata
  • Comments Comments (
    0
    ) |
2 Cadaveric PVS Use of cadaveric fascia for pubovaginal sling (allograft)
  • Comments Comments (
    0
    ) |
3 Xenograft PVS
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Retrospective nonrandom (2+ slings analyzed separately)
  • Comments Comments (
    0
    ) |
Study Country US
  • Comments Comments (
    0
    ) |
Sling Category Pubovaginal (bladder neck)
  • Comments Comments (
    0
    ) |
Multicenter? No
  • Comments Comments (
    0
    ) |
Institution Type Community hospital
  • Comments Comments (
    0
    ) |
No. of Surgeons Performing the Procedures ... Other ... 3 Attending surgeons
  • Comments Comments (
    0
    ) |
Surgeons' Training Urogynecology
  • Comments Comments (
    0
    ) |
Urology
  • Comments Comments (
    0
    ) |
Residents or Fellows Performing the Surgery? Yes
  • 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
    ) |
Comments (overall study) Retrospective and very little information provided about AEs or which AEs were looked for.
  • 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
Fascial PVS Obstruction requiring reoperation Prolonged postoperative voiding dysfunction or persistent irritative symptoms 23 ± 14 mo (mean ± SD) after discharge yes no 4 78 ND ND
  • Comments Comments (
    0
    ) |
Cadaveric PVS 25 ± 14 mo after discharge 4 80
Xenograft PVS 17 ± 6 mo after discharge 2 83
Total
Fascial PVS Organ injury in OR (urethra, bladder, bowel) Ureteral injury required reimplantation; likely related to concomitant uterosacral colpopexy 23 ± 14 mo (mean ± SD) unclear yes no 1 78 ND ND
  • Comments Comments (
    0
    ) |
Cadaveric PVS 25 ± 14 mo 0 80
Xenograft PVS 17 ± 6 mo 0 83
Total
Fascial PVS Organ injury in OR (urethra, bladder, bowel) Cystotomies 23 ± 14 mo (mean ± SD) unclear 3 78
  • Comments Comments (
    0
    ) |
Cadaveric PVS 25 ± 14 mo 1 80
Xenograft PVS 17 ± 6 mo 0 83
Total
Fascial PVS DVT DVT immediate postoperative period 1 78
  • Comments Comments (
    0
    ) |
Cadaveric PVS unclear 0 80
Xenograft PVS 0 83
Total