The National Institute for Clinical Excellence is examining photodynamic endometrial ablation 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 a provisional recommendation about photodynamic endometrial ablation.

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

Note that this document is not the Institute's formal guidance on this procedure. The recommendation is 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: 23 December 2003

Target date for publication of guidance: March 2004

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

Current evidence on the safety and efficacy of photodynamic endometrial ablation does not appear adequate to support the use of this procedure outside formal research. It is suitable for use only as part of a research study approved by a research ethics committee, with explanation to patients of the uncertainty about its safety and efficacy. Use of the Institute's Information for the Public is recommended. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

Photodynamic endometrial ablation is used to treat heavy menstrual periods, also known as menorrhagia.

Menorrhagia is a very common problem. Hysterectomy has been the standard treatment for women with menorrhagia who have not responded to medical treatment. Minimally invasive procedures to destroy the lining of the uterus (the endometrium) are alternatives to hysterectomy. They include using lasers, radiofrequency waves, electrocautery, microwaves, heated saline or a heated balloon. Photodynamic endometrial ablation is one of these minimally invasive procedures.

Photodynamic endometrial ablation involves injecting a photosensitive chemical into the uterine cavity through a hysterosalpingography catheter. A probe inserted through the cervix uses a laser to activate the photosensitive chemical, which destroys the endometrium. It can often be carried out under local anaesthetic on a day-case basis.

The evidence relating to this procedure was extremely limited and was based on one very small case series that included two women with menorrhagia and one woman with prolonged postmenstrual bleeding. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered photodynamic endometrial ablation to be an experimental procedure not yet ready for routine clinical use.

The evidence considered by the Advisory Committee was limited - the single study offered no assessment of pain or discomfort during the operation. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that the photosensitive chemical used in the procedure may cause skin photosensitivity. They commented that the evidence available was too limited to allow accurate assessment of the safety of the procedure.

NICE has issued safety and efficacy guidance on microwave endometrial ablation and balloon thermal endometrial ablation, and will issue interventional procedures guidance on free fluid thermal endometrial ablation in the future.

Fluid-filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding have been appraised as part of the Institute's technology appraisal work programme. Guidance is being prepared.

NICE is in the process of developing a clinical guideline on hysterectomy and alternative surgical treatments for menorrhagia and other conditions. The expected date of issue of this guideline is September 2005.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making it's provisional recommendations.

• Interventional Procedure Overview of Photodynamic endometrial ablation, November 2002

Available from: www.nice.org.uk/ip078overview