Patient decision aids have been launched by the National Institute for Health and Care Excellence to help women choose a surgical option for stress urinary incontinence or pelvic organ prolapse.
It comes in the wake of the national “pause” on the use by the NHS of surgical mesh or tape to treat stress urinary incontinence and for urogynaecological prolapse, and an ongoing independent review.
“The patient decision-making aids developed by NICE in association with patients, clinicians and professional bodies”
NICE’s new clinical guideline for urinary incontinence and pelvic organ prolapse recommends that women should use decision aids to reach an “informed decision” about their care.
Three patient decision aids will be launched alongside the final publication of the guideline today, said the institute. They cover surgery for stress urinary incontinence, surgery for vaginal vault prolapse and surgery for uterine prolapse.
The aids “place the woman at the heart of the decision”, said NICE, so they can work alongside their clinician to “pick the best course of treatment for her”.
The decision aids “detail every surgical option” NICE recommends women should be offered, using the “best available evidence”, said the institute.
They also “make clear” what non-surgical options NICE recommends as alternatives for stress urinary incontinence, vaginal vault prolapse and uterine prolapse.
The benefits and risks of each type of treatment are laid out to ensure every woman is “fully informed”, said NICE, including highlighting where evidence was limited.
“Surgeons must also record any intervention using surgical mesh/tape in a national database”
Patients, clinical experts and professional bodies were involved in the development of the patient decision aids, which are endorsed by NHS England and organisations representing surgeons.
There are a number of non-surgical options to treat both urinary incontinence and pelvic organ prolapse, which should be considered before surgery.
Non-surgical options for urinary incontinence include lifestyle interventions, such as caffeine reduction; physical therapies, such as pelvic floor muscle training; behavioural therapies, such as bladder training; and medicines.
Meanwhile, non-surgical options for pelvic organ prolapse include lifestyle modification, such as losing weight if the woman is overweight and minimising heavy lifting; topical oestrogen; pelvic floor muscle training; and pessary management.
If non-surgical options have not worked or if the woman decides against them, she may wish to discuss a surgical option with her clinician, noted NICE.
If alternative surgical procedures are not suitable for or acceptable to the woman to manage stress urinary incontinence, it said clinicians should consider intramural bulking agents.
There are a number of procedures recommended by NICE, including mesh procedures. While there was evidence of benefit, there was limited evidence on possible long-term harms of all surgical options, stated NICE.
In particular, the true prevalence of long-term complications following surgery with mesh was “unknown”, it highlighted.
If a woman’s chosen intervention was not available from the consulting surgeon, she should be referred to an alternative surgeon, the NICE guideline recommended.
In cases where it was agreed to use surgical mesh or tape, women must be fully informed of the risks, for example, dyspareunia – painful sexual intercourse – and other problems, said the guideline.
A follow-up appointment should be offered within six months to all women who have had urinary incontinence or prolapse surgery.
Complications related to the device should be reported to the Medicines and Healthcare products Regulatory Agency and details of the complications should be collected in a national database.
In July 2018 a national “pause” was announced by the government on the use by the NHS of surgical mesh or tape to treat stress urinary incontinence and for urogynaecological prolapse where the mesh was inserted through the vaginal wall.
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This “pause” takes the form of a high vigilance restriction period during which certain conditions apply.
It will remain in place until a number of conditions are met including registering all operations and any complications on a national database, and that surgery be performed by specialist surgeons based at specialist centres.
At the time of publication of this updated guideline, the high vigilance restriction was still in place and, until it is ends, professionals should continue to follow its requirements, said NICE.
Baroness Julia Cumberlege is also leading the Independent Medicines and Medical Devices Safety Review, which was initiated by the Department of Health and Social Care in February 2018.
The review is looking into the use of abdominal and vaginal pelvic mesh procedures. The review is still in progress and at present there is no date set for publication.
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NICE said its clinical guideline was completely independent of the Cumberlege review and was being published now within its “normal timeframe”.
This is the first national guideline to comprehensively cover the assessment and conservative treatment of pelvic organ prolapse, it noted.
Dr Paul Chrisp, director for the centre for guidelines at NICE, said: “The patient decision-making aids developed by NICE in association with patients, clinicians and professional bodies
“[They] will ensure every woman who is considering surgery for urinary incontinence or pelvic organ prolapse has the best evidence currently available to inform her of the benefits and risks of each type of procedure,” he said.
“It will ensure each woman is able to decide, with the help of her clinician, which option is best for her,” he said. “This might include the decision not to have surgery at all.
“Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape,” he noted.
“If a surgeon cannot provide a full range of choices to the woman, then she should be referred to one who can,” he said. “Surgeons must also record any intervention using surgical mesh/tape in a national database.”