1.1 Current evidence on the safety and efficacy of fetal vesico–amniotic shunt for lower urinary tract outflow obstruction does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.
1.2 Clinicians wishing to undertake insertion of a fetal vesico–amniotic shunt for lower urinary tract outflow obstruction should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that parents understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having fetal vesico–amniotic shunt for lower urinary tract outflow obstruction (see section 3.1).
1.3 This procedure should only be performed in centres specialising in invasive fetal medicine and in the context of a multidisciplinary team, which may include a consultant in fetal medicine, a paediatric urologist, a neonatologist and a specialist midwife.
1.4 Publication of safety and efficacy outcomes will be useful. A randomised trial (PLUTO) comparing fetal vesico–amniotic shunt with no treatment is in progress. Clinicians are encouraged to enter patients into this trial or the associated registry. The Institute may review the procedure upon publication of further evidence.