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Study Title and Description

Miniarc single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Miniarc single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes.
Author Kennelly MJ., Moore R., Nguyen JN., Lukban J., Siegel S.
Country Department of Urology, Carolinas Medical Center, Charlotte, NC 28207, USA. mjkennelly@earthlink.net
Year 2012
Numbers Pubmed ID: 22527540
23 (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
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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 Unclear/Not reported
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Surgeons' Training Not 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) Only intraoperative complications are reported. On p.1289: "Postoperative complications have previously been reported[8]. There were no additional complications that occurred from 12 to 24 months and the only device-related adverse events >2% were... [listed in table]" Citation #8 = Oliveira R, Botelho F, Silva P, Resende A, Silva C, Dinis P et al (2011) Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and MiniArc: results at 12-month follow-up. Eur Urol 59(6):940–944
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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 Airway difficulty "transferred from IV sedation to general anesthesia secondary to airway difficulty"
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Total Intraop In hospital No Not defined 1 188 Not Reported Not Reported
Minisling obturator "bronchospasm due to general anesthesia"
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Total Intraop In hospital No Not defined 1 188 Not Reported Not Reported
Minisling obturator "vaginal wall perforation owing to poor operative exposure in the office. procedure was terminated and the subject has a MiniArc implanted 7 days later in the hospital"
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Total Intraop In hospital No Not defined 1 188 Not Reported Not Reported
Minisling obturator "self-reported urgency incontinence - de novo"
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Total Postop after discharge No Not defined 4 188 Not Reported Not Reported
Minisling obturator "Temporary urinary retention"
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Total Postop After discharge No Not defined 6 188 Not Reported Not Reported
Minisling obturator Infection, UTI "UTI"
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Total Postop After discharge No Not defined 10 188 Not ReportedNot Reported Not Reported
Minisling obturator dyspareunia "dyspareunia"
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Total Postop After discharge No Not defined 4 188 Not ReportedNot Reported Not Reported
Minisling obturator urgency "urgency"
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Total Postop After discharge No Not defined 2 188 Not Reported Not Reported
Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue not defined specifically post op after discharge no not listed 3 188 n/a n/a
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Minisling obturator Pain, groin (new or different after surgery) "pain/discomfort- urogenital" post op after discharge no not listed 6 188 n/a n/a
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Minisling obturator Pain, other (new or different after surgery) leg pain post op after discharge no not listed 2 188 n/a n/a
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Minisling obturator Infection, other "vaginal" post op after discharge no not listed 4 188 n/a n/a
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Minisling obturator urinary frequency not further defined post op after discharge no not listed 2 188 n/a n/a
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Minisling obturator dysuria post op after discharge no not lsited 3 188 n/a n/a
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