National Institute for Health and Clinical Excellence (NICE)
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NICE urges further research on the safety and efficacy of two procedures to treat conditions affecting women

The long-term safety and efficacy is inadequate on two procedures NICE is calling for further evidence on

NICE is calling for more evidence to be gathered on the safety and efficacy of two procedures carried out to treat conditions effecting women.

The evidence on transvaginal laser therapy for stress urinary incontinence, and for transvaginal laser therapy for urogenital atrophy, does not show any short-term safety concerns. However, the evidence on their long-term safety and efficacy is inadequate.

Therefore NICE’s independent interventional procedures advisory committee has issued guidance that both procedures should only be used in the context of research.

Stress urinary incontinence is involuntary urine leakage on effort, exertion, sneezing or coughing.

Urogenital atrophy most often occurs during and after the menopause when the lack of the female hormone oestrogen affects the vagina, urethra and bladder trigone. The vagina can become shorted, less elastic and dryer with less lubricating mucus; the genital skin also looks paler.

Both conditions affect millions of people.

During the procedures a laser-probe device is inserted into the vagina to apply laser energy to the vaginal wall. The laser causes a controlled heating of the tissues, which claims to promote tissue remodelling. Treatment typically consists of three sessions at four to six weeks apart. They are used in the private sector but there does not appear to be evidence recorded of the long-term safety and efficacy of either procedure.

For both conditions NICE already has guidelines which make recommendations for non-surgical treatment. NICE's guideline on urinary incontinence and pelvic organ prolapse makes recommendations for the management of urinary incontinence in women, accompanied by a patient decision aid to promote shared decision making. First line treatment is conservative and includes lifestyle changes such as weight loss and pelvic floor muscle training. Surgical options are only offered if conservative measures do not help.

NICE's guideline on diagnosis and management of menopause describes the management of menopausal symptoms. The main treatments for urogenital atrophy are vaginal oestrogen, and non-hormonal lubricants and moisturisers.

Professor Kevin Harris, programme director and clinical advisor of NICE’s Interventional Procedures Programme, said: “These two conditions can have a huge impact on the quality of life of the women affected by them.

“If surgical options are required, women deserve safe and effective procedures to treat them.

“The lasers used for these conditions destroy or reshape vaginal tissue. This has the potential for serious risks and there is not adequate evidence that this is safe in the long term.

“Despite being carried out on a large number of women, it is disappointing that there is a lack of published evidence on the long-term efficacy of these procedures.

“Carefully conducted research is required to properly understand the risks so that women are not harmed by these procedures and to ensure their long-term safety and efficacy can be established.”

NICE interventional procedures guidance looks at procedures used for diagnosis or treatment. It considers if they are safe and work well enough for wider use in the NHS. An NHS organisation is not required to offer a procedure NICE has published guidance on.

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