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Study Title and Description

Prospective evaluation of a single incision sling for stress urinary incontinence



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Prospective evaluation of a single incision sling for stress urinary incontinence
Author Kennelly MJ, Moore R, Nguyen JN, Lukban JC, Siegel S.
Country McKay Urology Research, Charlotte, North Carolina, USA. michael.kennelly@carolinashealthcare.org
Year 2010
Numbers Pubmed ID: 20639024
1017 (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 Minisling obturator Mini arc sling
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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 Name Single incision sling for SUI
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Study Country US
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Canada
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UK
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Other ... Belgium
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Sling Category Minisling H (obturator)
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Multicenter? Yes
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Institution Type Academic hospital
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Community hospital
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training Urogynecology
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Urology
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Unclear/Not reported
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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) Poor study for AEs: very short list of complications assessed, not well defined time points for assessment of complications or definitions of certain complications.
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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
Minisling obturator Infection, UTI not listed not listed not listed not listed 8 157 not applicable n/a
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Minisling obturator constipation not defined not listed not listed not listed not listed 7 157 n/a n/a
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Minisling obturator Pain, unspecified area (new or different after surgery) not defined not listed not listed not listed not listed 6 157 n/a n/a
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Minisling obturator temporary urinary retention not defined not listed not listed not listed not listed 6 157 n/a n/a
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Minisling obturator de novo urge urinary incontinence not defined not listed not listed not listed not listed 5 157 n/a n/a
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Minisling obturator Infection, other vaginal- not further defined not listed not listed not listed not listed 4 157 n/a n/a
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Minisling obturator dyspareunia not further defined not listed not listed not listed not listed 4 157 n/a n/a
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Minisling obturator urinary urgency not further defined not listed not listed not listed not listed 4 157 n/a n/a
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