13/No.: 388 Registration date: 26/07/2012 Title: Efficacy and safety

13/No.: 388
Registration date: 26/07/2012
Title: Efficacy and safety of the artificial urinary sphincter (AS) in treating
postprostatectomy urinary incontinence
Year: 2012
Study coordinator: Carisi Anne Polanczyk
Research team: Rodrigo A. Ribeiro (IATS/UFRGS) Carisi Anne Polanczyk
(IATS/UFRGS) Guilherme Behrend Silva Ribeiro (HCPA/UFRGS) Brasil Silva Neto
(FM/UFRGS)
Type of financing: Public
Source of financing: MS/SCTIE/DECIT
Technology assessed: Artificial urinary sphincter
Objective of the study: To discover whether or not the artificial urinary sphincter is
effective and safe for managing moderate to severe urinary incontinence compared with
the masculine urethral sling and intraurethral injections in patients who underwent a
prostectomy.
Study population: Patients with moderate to severe postprostatectomy urinary
incontinence
Type of study: Rapid review
Outcomes: Efficacy (cure or improvement in urinary incontinence) and safety
(incidence rate of re-interventions, erosion, infection, urinary retention and chronic
pain)
Search strategy: The database used was MEDLINE, accessed through the PubMed
portal. The initial proposal was to conduct a search for clinical trials in the areas;
however, a recently published systematic review, that conducted a systematic search in
the MEDLINE, EMBASE and Cochrane CENTRAL database, discovered only one
small clinical trial (45 patients), in which a comparison was done of AS and
macroplastic injections. That way, we decided to conduct a systematic review that also
includes non-controlled trials, using a search strategy on the above comparison. We did
not use a specific filter for observational studies, only restrictions to publications that
were clearly of no interest, like letters and editorials.
Study inclusion criteria: Articles were included that evaluated any of the therapies of
interest (EA, sling or injections), independent of the control group, in men with
moderate to severe postprostatectomy urinary incontinence. Only those studies were
included where the AS was the AMS 800, the sling used was the AdVance, InVance or
Argus and Transobturador Inside-out, and the injections had been collagen or
macroplastic. For inclusion, the number of patients should be a minimum of 50.
Additionally, in the AS and sling articles, a maximum of 20% of the patients could have
previously done one of these procedures, on the contrary, the article was excluded. In
cases where the study contained patients that were not post-prostectomized, although
they accounted for less than 20% of the sample, the study was included. Articles that
also had patients with moderate to light incontinence were included for an analysis of
effectiveness as long as that fraction of patients did not pass 20% of the total sample.
However, since the complications rate was independent of the severity of urinary
incontinence, articles that had more than 20% of the patients with light incontinence or
that did not provide a description of the intensity of the urinary incontinence were
included for an analysis of the complications.
Type of study included:
Classification by grievance: Genitourinary system diseases
Nature of the technology: Medical and surgical procedures
Products and inputs for health
Nature of the technology´s application: Treatment
URL(s) of the study or document(s) of the study: PTC 05_2012_Esfíncter Urinário.pdf
Classification of the degree of recommendation:
Link: recomendacao.pdf
Translated by Tracie Houlihan