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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, 1100 9th AVE C-7 URO, Seattle, WA 98111, USA. derapp@yahoo.com
Year 2008
Numbers Pubmed ID: 18465078
18 (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 Bone anchored PVS
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Retrospective Cohort (all received same sling)
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Study Country US
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Sling Category ... Other ... Bone anchored retropubic bladder neck sling
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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 Urology
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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 ... 1 author with an affiliation with AMS which produces the bone anchors used in the study
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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
Bone anchored PVS Mesh erosion/extrusion/exposure/granulation tissue vaginal mesh extrusion 12-44 months after discharge 11 149 NA NA
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Bone anchored PVS Osteitis pubis Only conservative management needed 12-44 months after discharge yes none given 1 149 NA NA
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Bone anchored PVS Osteomyelitis 12-44 months after discharge yes none given 0 149 NA NA
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Bone anchored PVS Transient need for self cath Need for self cath which spontaneously resolved within 14 days 12-44 months after discharge no none given 10 149
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Bone anchored PVS Unspecified complication Study notes 19 patients with complication, only 12 discretely reported 12- 44 months unknown unknown 7 149 NA NA
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