The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on bone-anchored cystourethropexy (using data from In-Tac and Vesica as specified by SERNIP).
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.
This procedure is used to treat stress urinary incontinence in women.
Stress incontinence is urine leakage that occurs when the pressure within the abdomen is raised, during, for example, lifting, coughing or laughing. It is often due to damage to the pelvic muscles during childbirth, which weakens the normal muscular mechanism of preventing flow of urine into the urethra.
Stress incontinence is a common problem; most women with the condition are treated without surgery. Standard surgical treatments in women with severe stress incontinence include hysterectomy, vaginal repair, or laparoscopic or open surgery to lift the uterus (colposuspension). Minimally invasive procedures that can be carried out under local anaesthetic or sedation have been developed recently. These include needle suspension procedures. During 2000/2001, about 10,000 operations on the outlet of the female bladder were carried out in England (Source: Hospital Episode Statistics, ungrossed for missing data, Department of Health). About 4000 were open abdominal operations, and about 3000 were transvaginal.
Bone-anchored cystourethropexy is a minimally invasive bladder neck needle suspension procedure. Bone anchors are screwed into the pubic bone and sutures are then passed either side of the bladder neck. These sutures are then elevated and tied to the bone anchors to suspend the bladder neck.
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.