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====== Adverse Events ====== * '''<span style="color:#ff0000">Intra-operative</span>''' ** '''<span style="color:#ff0000">Urethral injury</span>''' *** '''Urethral injury during any implant surgery places the patient at risk for device infection due to the presence of colonizing bacteria in the urethra.''' *** '''<span style="color:#ff0000">If identified during implantation, the defect should be repaired, procedure should be abandoned and subsequent implantation should be delayed[https://pubmed.ncbi.nlm.nih.gov/31059663/ β ]</span>''' ****'''The risk of devastating device infection outweighs any benefit and thus the procedure should be aborted.''' ****'''The defect should be repaired and a catheter inserted for 7 days''' * '''<span style="color:#ff0000">Early Post-operative</span>''' ** '''<span style="color:#ff0000">Infection</span>''' *** '''Device infection occurs in <1-5% of cases''' ***'''Skin pathogens (staphylococcus epidermidis (most common) and staphylococcus aureus) are the most commonly cultured organisms''' ***'''<span style="color:#ff0000">Diagnosis and Evaluation</span>''' ****'''<span style="color:#ff0000">Presents with pain at the site of the AUS/scrotal pain, fever, scrotal warmth, erythema, edema, or skin changes, or frank purulence</span>''' ***'''<span style="color:#ff0000">Management</span>''' ****'''<span style="color:#ff0000">Urgent AUS explantation[https://pubmed.ncbi.nlm.nih.gov/31059663/ β ]</span>''' *****Implant infections are not amenable to antibiotic therapy ***** Traditional management includes device removal followed by a waiting period of several months with delayed reimplantation. ****'''AUS should not be reimplanted until at least 3 months''' to allow the infection to clear and inflammation to subside.'''[https://pubmed.ncbi.nlm.nih.gov/31059663/ β ]''' **'''<span style="color:#ff0000">Urinary Retention</span>''' ***'''Diagnosis and Evaluation''' ****'''Rule out inadvertent cuff activation''' *** '''Management''' ****'''In the immediate postoperative period, should be managed by with a small (10 or 12 Fr) catheter for 24-48 hours. Cuff deactivation must be confirmed before catheterization.''' ***** '''Instructions to deactivate AUS (pdf)''' '''(video)''' **** '''If the patient fails a voiding trial at 48 hours, suprapubic cystostomy drainage is recommended to reduce the risk for urethral erosion''' **** '''Retention persisting beyond several weeks implies undersizing of the cuff; in such cases, reoperation and cuff replacement may be required.''' Correlation with preoperative urodynamic findings is advised in such cases. * '''<span style="color:#ff0000">Late Post-operative</span>''' **'''<span style="color:#ff0000">Persistent leakage</span>''' **'''<span style="color:#ff0000">Cuff erosion</span>''' ***Occurs in up to 5% of AUS implantations **** '''Introduction of narrow back modification of AUS has reduced the risk of erosion''' ***Can be due to unrecognized urethral injury at the time of initial surgery or more likely due to subsequent instrumentation of the urethra including catheterization. ***'''Risk factors''' **** '''Campbellβs: radiation therapy, prior erosions with the need for removal of the device, prolonged catheterization and instrumentation, hypertension and other comorbidities''' ***** '''No increased risk of erosion with prior transobturator sling''' **** SASP 2016: '''radiation therapy, prior erosions''' or infection in a previous AUS, a '''prior urethroplasty''', '''multiple endoscopic treatments for bladder neck contracture or urethral stricture, or prior urethral stent placement'''. There is also a much lower but still significant increased risk of erosion with a '''prolonged postoperative catheterization interval''' (> 48 hours), '''or use of either a 3.5 cm or transcorporal cuff compared to a standard 4 cm cuff'''. ***** '''No increased risk of erosion with increasing age, proximal or distal bulbar urethral placement of the AUS, or prior radical prostatectomy''' ***'''Management''' ****'''AUS explant with the urethral catheter left in place for a few weeks to allow the urethral defect to heal[https://pubmed.ncbi.nlm.nih.gov/31059663/ <span style="color:#ff0000">β </span>]''' *****Immediate removal of all the components of the AUS is imperative because they are assumed to be infected. ****'''AUS should not be re-implanted until at least 3 months''' and urethral healing is confirmed by urethrography ** '''<span style="color:#ff0000">Urethral atrophy</span>''' *** '''Results from the chronic compression of the spongy tissue under the occlusive cuff''' *** '''Most common cause of gradual return of incontinence and revision of the AUS''' *** '''Management''' **** '''Options:''' ***** '''Cuff downsizing''' ***** '''Movement of the cuff to a more proximal or distal location where the urethra may be thicker''' ***** '''Placement of a second cuff in tandem''' **'''<span style="color:#ff0000">Mechanical failure</span>''' ***'''7-10-year device life for the AUS''' ****Rate of device failure increases with time, with '''failure rates of''' *****'''β24% at 5 years''' *****'''β 50% at 10 years''' ***'''Causes''' ****'''Failure in any of the 3 parts (cuff, balloon reservoir, or pump), the tubing, or connections suffer a micro-perforation with loss of fluid''' *** '''Management''' **** '''An AUS might need to be replaced over time due to persistent or recurrent incontinence generally due to:''' ****#'''Urethral atrophy''' ****# '''Improper cuff sizing''' ****#'''Partial fluid loss''' ****'''In the absence of infection or erosion, replacement of an isolated malfunctioning component may be feasible if the revision occurs within 3 years of implantation.''' ***** However, a slow leak from the PRB may be difficult to diagnose intraoperatively, and, if in doubt, total device replacement is prudent. **** '''Devices older than 3 years old should be replaced in entirety.''' **'''<span style="color:#ff0000">Urinary Retention</span>''' ***'''Late-onset urinary retention mandates endoscopic and urodynamic evaluation to rule out:''' **** '''Proximal urethral obstruction''' **** '''Erosion''' **** '''Detrusor failure'''
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