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Study Title and Description

Single-incision sling system as primary treatment of female stress urinary incontinence: prospective 12 months data from a single institution.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Single-incision sling system as primary treatment of female stress urinary incontinence: prospective 12 months data from a single institution.
Author Oliveira R., Botelho F., Silva P., Resende A., Silva C., Dinis P., Cruz F.
Country Hospital de São João, Serviço de Urologia, Porto, Portugal.
Year 2011
Numbers Pubmed ID: 21457429
1786 (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 119 patients with SUI underwent miniarc with 105 was avilabel for follow up
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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 ... Portugal
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Sling Category Minisling H (obturator)
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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 Unclear/Not reported
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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) prospective cohort study including 119 patients who underwent Mini-arc
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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 Organ injury in OR (urethra, bladder, bowel) bowel, bladder mean of 12 months Inhospital ? None 0 119
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Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue Mean follow up of 12 months after No None 2 105
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Minisling obturator Pain, groin (new or different after surgery) mean follow up of 12 months after No None 1 105
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Minisling obturator Return to OR urethrolysis 12 months after ? None 1 105
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Minisling obturator Pain, other (new or different after surgery) dyspareunia 12 months after ? None 4 105
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Minisling obturator Obstruction requiring reoperation >100 cc postvoid, require a catheter 12 months after ? None 3 105
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Minisling obturator Retention requiring surgery 12 months after ? None 1 105
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Minisling obturator Denovo urge 12 months after ? None 7 105
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