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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 --
Year 2010
Numbers Pubmed ID: 20639024
1849 (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 MiniArc
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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 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 Unclear/Not reported
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No. of Surgeons Performing the Procedures ... Other ... ≥16 (assuming at least 1 surgeon at each center)
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Surgeons' Training ... Other ... Some with urol and urogyn bkgd, but not discretely reported
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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 Industry
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Comments (overall study) - AMS supported study of AMS product (MiniArc) - AE: evaluated pain using a Wong-Baker pain scale at discharge and POD#7, but all other AE appear to be passively obtained - Other concomitant surgeries performed, but not listed. These could have contributed to AEs. - 38/188 procedures were performed in the office, there may have been more AEs due to this setting (or fewer, but paper states 3 vaginal peforations attributed to setting)
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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 ND
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Total ND ND no ND 8 188 NA NA
Minisling obturator Constipation ND
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Total ND ND no ND 7 188 NA NA
Minisling obturator Pain, unspecified area (new or different after surgery) Wong-Baker Pain scale
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Total POD#7 discharge possibly ND 6 188 NA NA
Minisling obturator Temporary urinary retention Required foley catheterization
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Total POD#7 discharge no ND 6 188 NA NA
Minisling obturator de novo urge incontinence UDI-6 question 2, baseline of 0-1 to a score of ≥2
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Total 12 months discharge yes ND 7.7% (I calculate 12) 157 NA NA
Minisling obturator Infection, surgical site/wound vaginal infection
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Total unclear, POD#7, or 6 mo postop ND moderate ND 4 188 NA NA
Minisling obturator Dyspareunia
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Total ND discharge yes ND 4 188 NA NA
Minisling obturator Urinary urgency ND
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Total ND discharge moderate ND 4 188 NA NA
Minisling obturator Vaginal perforation Paper suggests that all vaginal perforations occurred in the office setting and patients were brought back later and had procedure done in OR
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Total intraop during procedure moderate ND 3 188
Minisling obturator Organ injury in OR (urethra, bladder, bowel)
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Total yes 0 188 NA NA