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Study Title and Description

MiniArc single-incision sling in the office setting.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title MiniArc single-incision sling in the office setting.
Author Presthus JB., Van Drie D., Graham C.
Country Minnesota Gynecology and Surgery, Edina, MN 55435, USA. j.presthus@mngyn.com
Year 2012
Numbers Pubmed ID: 22381958
22 (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 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 Country US
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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 ... 3
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Surgeons' Training Urogynecology
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Urology
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General
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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 Industry
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Comments (overall study) small series of patients having mini-arc slings in office setting: did have 24 month data on 31 patients and used validated and objective measures; AEs were not well reported in this 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
Minisling obturator Pain, groin (new or different after surgery) urogenital pain 24 months after discharge no not provided 2 38 n/a n/a
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Minisling obturator Pain, unspecified area (new or different after surgery) leg pain 24 months after discharge no not provided 1 38 n/a n/a
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Minisling obturator Pain, other (new or different after surgery) other not listed 24 months after discharge no not provided 1 38 n/a n/a
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Minisling obturator de novo urgency not specifically defined 24 months after discharge no not provided 1 38 n/a n/a
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