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Study Title and Description

Transvaginal bone-anchored sling for the treatment of female stress urinary incontinence: effect of Valsalva leak point pressure and prior pelvic surgery on outcomes



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Transvaginal bone-anchored sling for the treatment of female stress urinary incontinence: effect of Valsalva leak point pressure and prior pelvic surgery on outcomes
Author Rapp DE, Nazemi TM, Kobashi KC, Govier FE
Country Continence Center at Virginia Mason Medical Center
Year 2008
Numbers Pubmed ID: 18465078
20081 (internal)

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


Extraction Form: Sling Adverse Events
Arms
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Retrospective Cohort (all received same sling)
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Study Name n/a
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Study Country US
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Sling Category ... Other ... Bone anchor polypropylens (InFast Female Sling System, AMS)
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Multicenter? No
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Institution Type Community hospital
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No. of Surgeons Performing the Procedures ... Other ... 2
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Surgeons' Training Not reported
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Passive
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Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding ... Other ... "None"
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Comments (overall study) AEs were neither a primary nor secondary outcome in this study. They were not pre-defined as outcomes, but described at the end of the results section.
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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
Total "Overall complication rate" Not defined Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 19 149 n/a n/a
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Total Mesh erosion/extrusion/exposure/granulation tissue "vaginal mesh extrusion" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 11 149 n/a n/a
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Total Return to OR "vaginal mesh extrusion [that] required formal operative excision" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 7 149 n/a n/a
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Total Obstruction requiring reoperation "need for operative sling loosening" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 0 149 n/a n/a
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Total Infection, other "osteomyelitis" Mean f/u 30 mos, minimum f/u 12 mos After discharge Yes Not defined 0 149 n/a n/a
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Total osteitis pubis "osteitis pubis, resolved with standard conservative intervention" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 1 149 n/a n/a
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Total "transient elevation in PVR requiring ISC - all cases resolved spontaneously within 14 days" [NOTE: this finding was NOT included in the overall complication rate] Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 10 149 n/a n/a
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Total "de novo urgency treated wtih standard anticholinergic therapy as per patient desire" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 25 149 n/a n/a
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Total "overall complication rate in group with VLPP >= 60" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 6 62 not reported not reported
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Total "overall complication rate in group with VLPP < 60" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 10 87 not reported not reported
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Total "overall complication rate in group with VLPP < 30" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 3 30 not reported not reported
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Total "overall complication rate in patients with no prior surgeries" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 14 92 not reported not reported
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Total "overall complication rate in patients with no one prior surgery" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 3 40 not reported not reported
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Total "overall complication rate in patients with 2 or more prior surgeries" Mean f/u 30 mos, minimum f/u 12 mos After discharge No Not defined 2 17 not reported not reported
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