Marys Medicine

Southcheshireccg.nhs.uk

BRIEFING:
Penile Prostheses for Erectile Dysfunction

Mr. John P Hampson
Public Health Specialist
Cheshire West & Chester Council
March 1st 2014
INTRODUCTION
Erectile dysfunction has been defined as the inability to achieve and maintain
a penile erection adequate for satisfactory sexual intercourse. It affects the
quality of life for both patients and partners and is associated with relationship
difficulties. Simple lifestyle measures such as regular exercise, smoking
cessation and weight loss are effective options in men with these risk factors
who have mild erectile dysfunction. Treatments include oral
phosphodiesterase (PDE) inhibitors, vacuum erection devices,
intracavernosal and intraurethral prostaglandins. 1
Two main types of penile prostheses are available – these are the semi-rigid
or malleable type and also an inflatable version. The latter is more
cosmetically acceptable. 2
This report is a rapid review of the literature which describes the effectiveness
and place in management of penile prostheses in erectile dysfunction.
METHOD
A literature search of Medline and Embase was conducted using the
keywords penile prosthesis, effectiveness and cost-effectiveness. In addition,
the websites and databases of Cochrane, SIGN, NHS Evidence, NICE,
Department of Health and the general internet were also searched.
PATIENT OUTCOMES & SATISFACTION
A retrospective study (2010) in Brazil analysed the effect of penile prostheses
and interviewed 139 men. Nearly two thirds (64%) returned to the same
sexual performance as they had before developing erectile dysfunction.
Follow-up was for 40 months. 3
In a separate study, 69 men (presenting after nerve sparing radical
prostatectomy) were given either tadalafil or a penile prosthesis. A significant
difference was observed in the International Index of Erectile Function (IIEF)
score. Follow-up was for up to 2 years. 4
Patient and partner satisfaction are generally high. One review recorded a
patient and partner satisfaction rate as over 90%. 5 In a different study, couple
satisfaction rate was 82% (n = 46 operations). No indication of the time period
was given. 6
Efficacy and satisfaction following penile prosthesis implants were assessed
using the IIEF score in 96 men. Significantly higher scores were obtained in
the prosthesis group which tended to maximise after 12 months. 7
Perhaps the largest study (n =224) was conducted in Chinese men over 10
years. After six months, satisfaction rates were reported to be 89%. 8
However, most of these studies are observational.
COST EFFECTIVENESS
A Canadian cost utility analysis of treatments for erectile dysfunction in spinal
cord injury found that sildenafil was much more cost-effective than a penile
prosthesis. 9 This appears to be the only published cost effectiveness paper to
appear in the literature.
ADVERSE EFFECTS
Perioperative complications include infections and later erosions of the
prosthesis and mechanical failure. These problems frequently require a
second operation. 2 In the Brazilian study mentioned above 3 25% of men had
immediate post-operative pain, 7.9% had local infection and 8.6% had other
complications.
The majority of revisions (65%) are performed because of mechanical failure.
Survival is around 96% at five years and 60% at 15 years. 10 In general, a
revision rate of 7% per year can be expected. 11
NATIONAL GUIDELINES
There is a good consensus that management of erectile dysfunction with a
penile prosthesis is a third line treatment. 11 5 1 Other authors have described
penile prosthesis use as a last resort if all first and second line treatments
have failed. 12
The National Institute for Health and Care Excellence (NICE) recommend the
use of penile prostheses as an option (amongst others) where oral therapy
has failed. However these recommendations are based on observational
studies. 13
The Department of Health in its circular on treatment for impotence 14 lists the
following medical conditions which are appropriate for treatment:-
 multiple sclerosis  Parkinson's disease  poliomyelitis  prostate cancer  prostatectomy  radical pelvic surgery  renal failure treated by dialysis or transplant  severe pelvic injury  single gene neurological disease  spinal cord injury  spina bifida However, the circular refers to oral therapy. It could be inferred that men requiring penile prostheses must come from one of the categories above because sildenafil (and others) is recommended as first line treatment. The British Society for Sexual Medicine guidelines on the management of erectile dysfunction 11 suggest that penile prostheses are particularly suitable for those with severe organic erectile dysfunction especially if the cause is Peyronie's disease or post-priapism. Others have stated that Peyronie's disease is characterised by a fibrous plaque leading to penile curvature which causes pain during an erection. Use of a prosthesis can correct this malformation and permit a normal sex life. 15 Most CCGs do not fund penile prostheses. This is based on the limited
amount of evidence of cost effectiveness, the unknown impact on general
quality of life and a high proportion of patients having major complications.
CONCLUSIONS/ SUMMARY
1. Data on the use of penile prostheses in the treatment of erectile dysfunction are limited. Numbers of participants are small and the trials are observational and uncontrolled. 2. Implant surgery is expensive (costing several thousand pounds) and is unlikely to be cost effective according to NICE criteria. 3. Penile prostheses are considered to be third line treatments. 4. There is a need for long term cost-effectiveness studies which also address the impact on general quality of life. 5. There may be a small cohort of men with an anatomical malformation or mechanical problem with the penis which is highly unlikely to respond to standard (oral) therapy. 6. Most CCGs do not fund this treatment.
RECOMMENDATIONS
1. Penile prostheses for erectile dysfunction should be assigned low 2. In rare circumstances, funding will be available for men who have failed to respond to the British Society for Sexual Medicine guidelines first and second line recommended treatments and who have one of the following conditions:-  Peyronie's disease.  Post – priapism.  Malformation of the penis. REFERENCES
(1) Munser, A., Kalsi, J., Nazareth, I., and Arya, M. Clinical Review: Erectile
dysfunction. BMJ 2014; 348.
(2) Bettocchi C, Palumbo F, Spilotros M, Palazzo S, Saracino GA, Martino P et al. Penile prostheses. Therapeutic Advances in Urology 2010; 2(1):35-40.
(3) Paranhos M, Andrade E, Antunes AA. Penile prosthesis implantation in an academic institution in Latin America. International Braz J 2010; 36(5):591-
601.
(4) Megas G, Papadopoulos G, Stathouros G, Moschonas D, Gkialas I, Ntoumas K. Comparison of efficacy and satisfaction profile, between penile prosthesis
implantation and oral PDE5 inhibitor tadalafil therapy, in men with nerve-
sparing radical prostatectomy erectile dysfunction. BJU International 2013;
112(2):E169-E176.
(5) Wespes E, Eardley F, Guiliano F, Hatzichristou D, Hatzimouratidis K, Moncada I et al. Guidelines on male sexual dysfunction: Erectile dysfunction and premature ejaculation. 1-53. 2013. European Association of Urology. (6) Porena M, Mearini L, Marzi M, Zucchi A. Penile prosthesis implantation and couple's satisfaction. Urologia Internationalis 1999; 63(3):185-187.
(7) Mulhall JP, Ahmed A, Branch J, Parker M. Serial assessment of efficacy and satisfaction profiles following penile prosthesis surgery. Journal of Urology
2003; 169(4):1429-1433.
(8) Song WD, Yuan YM, Cui WS, Wu AK. Penile prosthesis implantation in Chinese patients with severe erectile dysfunction: 10 year experience. Asian
Journal of Andrology 2013; 15(5):658-661.
(9) Mittmann N, Craven BC, Gordon M. Erectile dysfunction and spinal cord injury: A cost utility analysis. J Rehabil Med 2005; 37:358-364.
(10) Henry, G. D., Donatucci, C. F., and Conners, W. An outcome analysis of over 200 revision surgeries for penile prosthesis implantation: a multicenter study.
J Sex Med 2012; 9:309-315.
(11) Hackett G, Dean J, Kell P, Price D, Ralph D, Speakman M et al. British Society for Sexual Medicine Guielines on the Management of Erectile Dysfunction. 1-34. 2007. Staffordshire, British Society for Sexual Medicine. (12) Kendirci M, Tanriverdi O, Trost L, Hellstrom WJ. Management of sildenafil treatment failures. Current Opinion in Urology 2006; 16(6):449-459.
(13) Prostate cancer: diagnosis and management. 175, 1-45. 2014. London, National Institute for Health and Care Excellence. Clinical Guideline. (14) Treatment for impotence. 148, 1-7. 1999. London, Department of Health. Health Service Circular. (15) Ateia AH, Voinescu O, Geavlete R. Penile prosthesis in the surgical treatment of Peyronie's disease. Journal of Medicine & Life 2012; 5(3):280-282.

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