The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on extracorporeal shockwave therapy for Peyronie's disease.
As part of NICE's work programme, the current guidance was considered for review but did not meet the review criteria as set out in the IP process guide. The guidance below therefore remains current.
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 is generally localised using a ultrasound scanner.
Shockwaves per session range from 2000–3000, with the average patient receiving around 3-5 treatment sessions.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.