Safyre

StudyStudy type and ELNo. of patientsPatient characteristicsInterventionLength of follow-upOutcome measuresEffect sizeAdditional comments
Palma 2005833Case series
EL = 3
126 (140 procedures)F mean age 63 (40–71), stress UI. 49% had cystocele, and 10% rectocele
60% had failed prior continence surgery
Exclusions: DO, max. flow rate < 15 ml/s and/or PVR > 20% of volume voided.
Polypropylene mesh sling (Safyre)Mean 18 months (12–36)Subjective cure/ improvement/ failure*92% cure
2% improved
6% failure
Funding: none declared.
Cystoscopy during procedure
*cure = dry, improvement = leakage < once every 2 weeks, failure = leakage > once/week.
Hospital parametersOp time 25 min (unclear whether mean value)
Hospital stay 24 (12–36) h
Complications2% bladder perforation
3% retention > 4 weeks after surgery, reqd loosening of sling tension
21% transient de novo urgency
5% vaginal erosion of tape (with pain, discharge, bleeding, dyspareunia, dysuria, recurrent UTI): tape trimmed in 4, and covered by advanced vaginal flap in 2
5% reqd tightening of tape
No cases of intra-op bleeding, or urethral or vaginal perforation

From: Evidence tables for included studies

Cover of Urinary Incontinence
Urinary Incontinence: The Management of Urinary Incontinence in Women.
NICE Clinical Guidelines, No. 40.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2006 Oct.
Copyright © 2006, National Collaborating Centre for Women’s and Children’s Health.

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