The National Institute for Clinical Excellence is examining extracorporeal shockwave therapy (ESWT) for Peyronie's disease and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about extracorporeal shockwave therapy (ESWT) for Peyronie's disease.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow, after the consultation period ends, is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendation, in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 2 September 2003

Target date for publication of guidance: 26 November 2003

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety of extracorporeal shockwave therapy (ESWT) for Peyronie's disease appears adequate. However, the evidence on the efficacy does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake ESWT for Peyronie's disease should inform the clinical governance leads in their trusts. They should ensure that patients offered the procedure understand the uncertainty about its efficacy, and that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

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 forcing the penis to bend or arc during erection.

For many patients, Peyronie's disease results in sexual problems due to the difficulty in attaining and/or maintaining erections.

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. Numerous surgical techniques have been developed for patients with more severe symptoms and those who have been refractory to conservative treatment.

The procedure involves the use of shockwave lithotripsy technology to treat Peyronie's disease. 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 these shockwaves, and it is generally localised using an ultrasound scanner. The procedure can be performed with or without sedation.

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 Overview (see Appendix A).

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, interpatient variability, and the natural history of the disease were potential problems when evaluating the evidence.

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 Overview (see Appendix A).

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.

The Advisory Committee commented that good comparative data would be useful in establishing the efficacy of this procedure.

The following source of evidence was considered by the Interventional Procedures Advisory Committee.

• Interventional Procedure Overview of Extracorporeal Shockwave Therapy for Peyronie's Disease, March 2003