Evidence-based recommendations on intramural urethral bulking procedures for stress urinary incontinence in women. Intramural urethral bulking aims to augment the urethral wall and increase the urethral closure force.
In July 2018, the Government announced a period of ‘high vigilance restriction’ on the use of a group of procedures, including this procedure, to treat stress urinary incontinence and pelvic organ prolapse, in England. This followed a recommendation by Baroness Cumberlege, who is chairing an independent review of surgical mesh procedures and has heard from women and families affected by them. For details, see the letter from NHS England and NHS Improvement to trust medical directors. The high vigilance restriction period was extended in March 2019. In April 2019, we updated our guideline on urinary incontinence and pelvic organ prolapse and published patient decision aids to support people to make informed decisions about surgery for stress urinary incontinence, uterine prolapse and vaginal vault prolapse.
Guidance development process
M56.3 Endoscopic injection of inert substance into outlet of female bladder
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.