The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on insertion of biological slings for stress urinary incontinence.
October 2018: Following advice from its Clinical Advisory Group, NHS England and NHS Improvement have announced that a process of high vigilance scrutiny should apply to the use of a group of procedures, including this procedure, that are used to treat stress urinary incontinence and pelvic organ prolapse in England. For details, see the letter from NHS England and NHS Improvement to trust medical directors. We will work with NHS England to produce a shared decision making tool, to be available when our guideline on urinary incontinence and pelvic organ prolapse publishes early next year.
Stress urinary incontinence is the involuntary leakage of urine during exercise or certain movements such as coughing, sneezing and laughing. It is usually due to weak or damaged muscles in the pelvic floor or sphincter.
Conservative treatments include pelvic floor muscle training, electrical stimulation, biofeedback, and mechanical devices (urethral plugs and inserts). Surgery is usually used if conservative treatments fail. There are four main types of surgical intervention: colposuspension, insertion of a tension-free vaginal tape, traditional suburethral slings and injectable agents.
Sling procedures are performed partly through the vagina and partly through a small abdominal incision, usually under general anaesthesia. The sling may be made of a strip of tissue from the patient's own abdominal fascia, from human donor tissue or from animal tissue. A tunnel is created under the mid or proximal urethra, extending upwards through the endopelvic fascia on both sides towards the back of the rectus sheath. The sling of allograft or xenograft material is suspended from the rectus sheath or anterior abdominal wall by loose sutures, creating a supporting 'hammock' for the urethra. Bone screws may sometimes be used to hold the sutures in place and anchor the sling to the pubis.
Guidance development process
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.