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Study Title and Description

Long-term surgical results of pubovaginal sling procedure using polypropylene mesh in the treatment of stress urinary incontinence.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Long-term surgical results of pubovaginal sling procedure using polypropylene mesh in the treatment of stress urinary incontinence.
Author Kuo HC.
Country Department of Urology, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. hck@tzuchi.com.tw
Year 2005
Numbers Pubmed ID: 15756067
1056 (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 Synthetic PVS Pubovaginal sling with Polypropylene Mesh
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Prospective Cohort (all received same sling)
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Study Country ... Other ... Taiwan
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Sling Category Pubovaginal (bladder neck)
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Other ... Pubovaginal WITH synthetic mesh
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Multicenter? No
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Institution Type Unclear/Not reported
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No. of Surgeons Performing the Procedures 1
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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 Active
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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 Not reported
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Comments (overall study) This is a prospective cohort of a single surgeon practice. Patients were followed up at 6 month postop in the clinic and annually via e-mail or telephone.
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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
Synthetic PVS Mesh erosion/extrusion/exposure/granulation tissue Undefined 45 months After discharge Yes Undefined 2 108
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Total
Synthetic PVS Obstruction requiring reoperation Patients with bladder obstruction underwent videourodynamics 2 weeks postop and urethrolysis if evidence of obstruction 45 months In-hospital and after discharge yes Patients with bladder obstruction underwent videourodynamics 2 weeks postop and urethrolysis if evidence of obstruction 4 108
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Total
Synthetic PVS Retroperitoneal hematoma In-hospital Yes 2 108
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Total
Synthetic PVS Retention requiring catheter In-hospital Patients with severe difficulty voiding after Foley removal underwent videourodynanmics, and sling tension released if obstruction confirmed, then CIC. 7 108
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Total
Synthetic PVS De Novo Urgency After discharge undefined 13 108
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Total
Synthetic PVS De Novo Urge Incontinence
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Total After discharge undefined 7 108