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Study Title and Description

Short-term outcomes with the Ajust system: a new single incision sling for the treatment of stress urinary incontinence



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Short-term outcomes with the Ajust system: a new single incision sling for the treatment of stress urinary incontinence
Author Meschia M, Barbacini P, Baccichet R, Buonaguidi A, Maffiolini M, Ricci L, Braghin C, Brusati V, Dell'Utri C, Spreafico L.
Country --
Year 2011
Numbers Pubmed ID: 20798919
20079 (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 AJUST system used in consecutive patients. This is a single-incision mini-sling placed through the obturator membrane
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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 AJUST system trial
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Study Country Italy
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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 ... 5
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Surgeons' Training Urogynecology
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Residents or Fellows Performing the Surgery? No
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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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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 At least two positive urine cultures during the follow-up period (exams were scheduled after 1, 3, and 6 months from surgery). 6 months after discharge no 8 105
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Minisling obturator "De novo" OAB symptoms "De novo" OAB symptoms 6 months After discharge no 9 105
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Minisling obturator Dyspareunia Anchor detach/ dyspareunia :one of the fixating anchors found at the level of the lateral vaginal fornix 6 months After discharge no 1 105
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Minisling obturator Voiding dysfunction Voiding difficulty was assessed by means of US scan and ascertained when residuals were ≥100 ml in at least three consecutive micturitions. 6 months After discharge Unclear 4 105
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Minisling obturator Retention requiring surgery Retention that required section of the tape after 9 days 6 months After discharge Yes 1 105
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Minisling obturator Return to OR one tape section on the 9th post-operative day, three for stress incontinence, one for pelvic organ prolapse and one for anchor removal 6 months After discharge Unclear 6 105
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