2 The procedure

2.1 Indications

2.1.1 Peyronie's disease is a localised connective tissue disorder of unknown cause. It is characterised by the formation of inelastic fibrous plaques within the erectile tissue of the penis. The hardened plaque reduces flexibility, causing pain and causing the penis to bend or arc during erection.

2.1.2 For many patients, Peyronie's disease results in sexual problems because there is difficulty in attaining and/or maintaining erections.

2.1.3 Treatment options for Peyronie's disease include pharmacological interventions, radiation and surgery. They are designed to alleviate the symptoms rather than to cure the disease. A number of surgical techniques have been developed for patients with more severe symptoms and for patients who have been refractory to conservative treatment.

2.2 Outline of the procedure

2.2.1 The procedure involves the use of shockwave lithotripsy technology. Extracorporeal shockwaves are high-pressure, low-frequency sound waves, generated by a device outside the body and applied to the affected tissue in a site-specific manner. In Peyronie's disease, the penile plaque is the target of the shockwaves, and it is generally localised using an ultrasound scanner. The procedure can be performed with or without sedation.

2.3 Efficacy

2.3.1 From comparative studies, the main benefits of ESWT were the alleviation of pain and reduction of angulation of the penis. In one comparative study, 50% of patients (10/20) receiving ESWT experienced a decrease in curvature of at least 30%. Case series evidence also suggested some improvement of sexual performance. For more details refer to the sources of evidence section.

2.3.2 The Specialist Advisors commented on the difficulty of evaluating efficacy, given the lack of controlled data and agreement regarding relevant endpoints. The Advisors also noted that placebo response, inter-patient variability, and the natural history of the disease were potential problems when evaluating the evidence.

2.4 Safety

2.4.1 In the studies identified, relatively few complications were reported. Complications were mostly of a transient nature and included urethral bleeding, bruising, skin discoloration due to petechiae, and haematoma. The relationship between the energy level used in the treatment and the reported complications is unclear. For more details refer to the sources of evidence section.

2.4.2 The Specialist Advisors did not note any particular safety concerns about this procedure. Superficial bruising and moderate local pain were noted as potential adverse events.

2.5 Other comments

2.5.1 Good comparative data would be useful in establishing the efficacy of this procedure.

Andrew Dillon
Chief Executive
December 2003