Apresentação realizada Oslo - Noruega, 2015.

1. ABSTRACT
An artificial urinary sphincter (AS) is an implantable device used to treat patients with urinary
incontinence associated with radical prostatectomy (Fig. 1). Although apparently effective, this
technology has a very high cost and it is not reimbursed by the Public Health System. Aim: To analyze
the efficiency of the use of AS in the treatment of post prostatectomy urinary incontinence when
compared to other treatment strategies. Methods: Systematic literature survey including data from
Pubmed, Embase, Cochrane library and International Health Technology Assessment (HTA) sites
published since 2012. Search terms used were artificial urinary sphincter and urinary incontinence.
Results: The survey was able to identify 129 publications related to this subject. Careful title screening
and thorough abstract reading limited the number of included articles to 10 (4 systematic reviews, 2
health technology assessments, 2 observational studies, 1 economic evaluation and one clinical
guideline). No controlled randomized clinical trials were found comparing the use of this technology
with other strategies. Data from the available studies indicate that the AS is currently indicated in
cases of moderate to severe urinary incontinence, with high success rates and high patient satisfaction
scores, in spite of the eventual need for late revision and even removal of the device along the years.
Conclusion: Due to the low evidence score of the available literature, great care is to be use in the
eventual incorporation of this technology. Careful economic evaluations and the development of
clinical guidelines are deemed necessary to assure an informed decision on this subject.
METHODS
The question that guided the search for evidence is based in the PICO strategy, with Population (P) the
patients undergoing radical prostatectomy with moderate or severe urinary incontinence, Intervention
(I) the artificial urinary sphincter (AS), Comparator (C ) other surgical therapies and Outcomes (O) the
resolution of incontinence, complications and costs. The question was "Which is the efficiency for
treatment of moderate or severe urinary incontinence after radical prostatectomy compared to other
surgical therapies?". The search of studies was conducted in the PubMed, EMBASE, Cochrane, HTA
agencies linked to INATHA and Ministry of Health of Brazil. The terms Mesh used were "artificial urinary
sphincter" and "urinary incontinence", adapted to the search in the different base systems. The criteria
for selecting studies were agree with the question of research, published from 2012 and study design
(systematic reviews, technology assessment and recent clinical studies have not assessed by the
secondary studies). The studies were evaluated for quality of evidence according the Guidelines of the
Brazilian Network Technology Assessment – REBRATS.
RESULTS
EFFICIENCY OF THE ARTIFICIAL URINARY SPHINCTER IN THE TREATMENT OF
POST PROSTATECTOMY URINARY INCONTINENCE
Eliane Molina Psaltikidis - MSc. RN. HTA center; Joaquim Murray Bustorff-Silva - MD. Ph.D. pediatric surgeon;
Mariângela Ribeiro Resende - MD. Ph.D. infectious diseases
Clinical Hospital of State University of Campinas - UNICAMP
Ten studies were selected for analysis as shown in Figure 1.
The systematic reviews analyzed1,2,3,4 identified only one randomized
controlled trial5, with small sample (45 patients), comparing AS and
injection of Macroplastique® with favorable outcome for the use of the
AS in the group with severe incontinence (OR 8.89, 95% CI 1.40-56.57).
Stands out a systematic review of high methodological rigor2 using
GRADE system, which presented the main results of using the AS:
 Social Continence (≥1 diaper/day) - on average 79% (ranging from
61 to 100%).
 AS revision rate of 26% (14-44%) due to mechanical failure (6%),
erosion / infection (8.5%) and urethral atrophy (7.9%).
After 2 years follow-up, 84 to 98% of patients have functioning with
or without revision.
Four studies evaluated patient satisfaction, by various methods, but
all with results favorable to the use of AS.
Figure 1. Artificial
urinary sphincter (AS)
Overall, the reviews agree on the need for further studies comparing AS with surgical alternatives, with
greater methodological rigor, about the effectiveness, occurrence of mechanical failure, complications
and patient satisfaction.
Two clinical trials not covered by the systematic reviews were analyzed:
Cohort of 77 patients with AS6 assessed the outcomes related them to the previous radiotherapy. The
overall rate of continence (no diaper or 1 daily) was similar in both groups (87%). The surgical revision
rate of AS was 10% and 12% between irradiated and non-irradiated, though the incidence of urethral
stricture was higher among irradiated (62% vs 10%).
A retrospective observational study of 57 patients with AS7, overall rate of AS of stay was 80% after 15
and 20 years. Continence (no use of diaper) of 77% and 89% patient satisfaction.

2. RESULTS CONTINUED
Two technology assessments were included in the analysis, both from the Ministry of Health of Brazil:
One HTA8 analyzed 23 studies on AS and urethral sling, all non-comparative, uncontrolled and potential
selection bias. The results suggest that for moderate to severe incontinence AS has a similar effect to
the slings (79% and 75%), while for severe incontinence AS reporting had higher cure rate and/or
improvement (90%) to the slings (71 %).
Recommendation Report9 of the AS for severe urinary incontinence after prostatectomy for the public
health system was analysed. It concluded that the quality of the evidence in studies about AS is low,
with only one randomized study, and there isn´t observational studies comparing use of sling versus AS.
Several studies have analyzed global cases of urinary incontinence without stratification in severity and
differences in inclusion criteria and measurement of outcomes. The recommendation decided to no
incorporation of AS as isolated technology. Suggested the elaboration of Clinical Protocol for national
determination about the options of care for patients with urinary incontinence in the public health
system.
An economic evaluation10, prepared by the Ministry of Health of Brazil, used decision model (Markov)
and considered life expectancy, complications, life quality, short and long-term costs of three strategies
(AS, Sling and treatment conservative). The result of the strategies was:
For conservative treatment no has extra-charge, but was less effective therapy;
For AS was average cost of R$ 29,212 per patient (about U$ 9,700);
For the Sling was average cost of R$ 7,704 (about U$ 2,600);
Demonstrated incremental cost-effectiveness Sling and AS with conservative treatment,
demonstrating cost-effectiveness of Sling for moderate cases and AS for severe cases of urinary
incontinence.
Despite the AS and slings not be incorporated in the public health system, the National Health Agency
(ANS), which governs the private health system in Brazil, developed a clinical protocol11 for the use of
these materials for urinary incontinence post-prostatectomy subsidizing its introduction in the list of
procedures covered by private health insurance providers.
CONCLUSIONS
REFERENCES
1. Silva L, Andriolo R, Atallah A, da Silva E. Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate. Cochrane Database Syst Rev [Internet]. 2014;(6):1–
13. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21491408
2. Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu J-N. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic
incontinence. Eur Urol [Internet]. 2013 Apr;63(4):681–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23219375
3. Montague DK. Artificial urinary sphincter: long-term results and patient satisfaction. Adv Urol [Internet]. 2012 Jan [cited 2014 Aug 2];2012:835290. Available from:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3318201&tool=pmcentrez&rendertype=abstract
4. Brasil. Agência Nacional de Saúde Suplementar - ANS., Brasileira AM. Diretrizes Clínicas na Saúde Suplementar [Internet]. 2012. Available from: http://apsredes.org/site2012/wp-
content/uploads/2012/09/DIRETRIZES_SAUDE-SUPLEMENTAR2.pdf
5. Imamoglu MA, Tuygun C, Bakirtas H, Yigitbasi O, Kiper A. The comparison of artificial urinary sphincter implantation and endourethral macroplastique injection for the treatment of
postprostatectomy incontinence. Eur Urol 2005;47:209-13.
6. Sathianathen NJ, McGuigan SM, Moon D a. Outcomes of artificial urinary sphincter implantation in the irradiated patient. BJU Int [Internet]. 2014 Apr [cited 2014 Aug 2];113(4):636–41.
Available from: http://www.ncbi.nlm.nih.gov/pubmed/24131859
7. Léon P, Chartier-Kastler E, Rouprêt M, Ambrogi V, Mozer P, Phé V. Long-term functional outcomes after artificial urinary sphincter (AMS 800®) implantation in men with stress urinary
incontinence. BJU Int [Internet]. 2014 Jun 23 [cited 2014 Aug 2];1–21. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24958004
8. Brasil, Ministério da Saúde. Secretaria de Ciência T e IED de C e T. PTC 05/2012. Eficácia e segurança de esfíncter urinário artificial no tratamento da incontinência urinária [Internet].
Brasília; 2012. Available from: http://portal2.saude.gov.br/rebrats/visao/estudo/detEstudo.cfm?codigo=388&evento=6&v=true
9. Brasil M da SCN de I de T no S-C. Esfíncter urinário artificial na incontinência urinária masculina grave pós - prostatectomia - Relatório de Recomendação [Internet]. 2013. Available
from: http://portalsaude.saude.gov.br/images/pdf/2014/janeiro/28/EsfincterUrinario-final.pdf
10. Brasil, Ministério da Saúde. Secretaria de Ciência T e IED de C e T. Custo-efetividade do Esfíncter Urinário Artificial e Sling Urinário no tratamento de incontinência urinária no
tratamento de incontinência urinária pós-prostatectomia [Internet]. Brasília; 2012 p. 1–32. Available from:
http://portal2.saude.gov.br/rebrats/visao/estudo/detEstudo.cfm?codigo=412&evento=6&v=tru
11. Brasil. Agência Nacional de Saúde Suplementar - ANS., Brasileira AM. Diretrizes Clínicas na Saúde Suplementar [Internet]. 2012. Available from: http://apsredes.org/site2012/wp-
content/uploads/2012/09/DIRETRIZES_SAUDE-SUPLEMENTAR2.pdf
EFFICIENCY OF THE ARTIFICIAL URINARY SPHINCTER IN THE TREATMENT OF
POST PROSTATECTOMY URINARY INCONTINENCE
Eliane Molina Psaltikidis - MSc. RN. HTA center; Joaquim Murray Bustorff-Silva - MD. Ph.D. pediatric surgeon;
Mariângela Ribeiro Resende - MD. Ph.D. infectious diseases
Clinical Hospital of State University of Campinas - UNICAMP
The AS has been used for decades in the treatment of moderate to severe urinary incontinence, having
the support only several observational studies with continence results or significant improvement of
incontinence. The literature also reports complications requiring surgical revision of the device over the
years and possible replacement or withdrawal.
In the search for evidence, we met several systematic reviews and recent technology assessments that
highlight the lack of randomized controlled trials comparing the AS to other surgical treatments for
urinary incontinence.
The Brazilian public health system did not incorporate the AS, considering the lack of solid evidence
about its benefits, costs and the absence of a clinical protocol nationwide to assist patients with urinary
incontinence. In contrast, the use of AS has been financed by the private health system, pressing public
health services and professionals for the widespread introduction of technology. It is therefore essential
and necessary to perform new studies comparing surgical alternative treatment of urinary incontinence,
especially moderate and severe, with greater methodological rigor.