PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial*

Objectives  The primary objective is to determine whether intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction, compared with conservative, noninterventional care, improves prenatal and perinatal mortality and renal function. The secondary objectives are to determine if shunting for fetal bladder outflow obstruction improves perinatal morbidity, to determine if improvement in outcomes is related to prognostic assessment at diagnosis and, if possible, derive a prognostic risk index and to determine the safety and long‐term efficacy of shunting.Design  A multicentre randomised controlled trial (RCT).Setting  Fetal medicine units.Population  Pregnant women with singleton, male fetus with isolated lower urinary tract obstruction (LUTO).Methods  Following ultrasound diagnosis of LUTO in a male fetus and exclusion of other structural and chromosomal anomalies, participation in the trial will be discussed with the mother and written information given. Consent for participation in the trial will be taken and the mother randomised via the internet to either insertion of a vesicoamniotic shunt or expectant management. During pregnancy, both groups will be followed with regular ultrasound scans looking at viability, renal measurements and amniotic fluid volume. Following delivery, babies will be followed up by paediatric nephrologists/urologists at 4–6 weeks, 12 months and 3 and 5 years to assess renal function via serum creatinine, renal ultrasound and need for dialysis/transplant.Main outcome measures  The main outcome measures will be perinatal mortality rates and renal function at 4–6 weeks and 12 months measured via serum creatinine, renal ultrasound and need for dialysis/transplant.Funding  Wellbeing of Women.Estimated completion date  September 2010.Trial algorithm  Principal investigators from PLUTO trial sites with Local Research Ethics Committee and Research and Development approval to be named as co‐authors   The PLUTO trial management group includes Prof Mark Kilby (chief investigator), Prof Khalid Khan, Dr Katie Morris, Jane Daniels, Prof Richard Gray and Laura Magill.At the time of submitting this protocol, the following clinicians have obtained approval for randomisation: Prof Mark Kilby, Prof Khalid Khan, Mr Bill Martin and Mr Peter Thompson—Birmingham Women’s Hospital NHS Trust;Prof Zarko Alfirevic—Liverpool Women’s Hospital NHS Trust;Mr Simon Kenny—Royal Liverpool Children’s NHS Trust;Dr Sarah Bower—King’s College Hospital NHS Trust;Dr Stephen Sturgiss—The Royal Victoria Infirmary, Newcastle Upon Tyne Hospitals NHS Trust;Mr Dilly Anumba—Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Trust;Mr Gerald Mason—The Leeds Teaching Hospitals NHS Trust;Dr Graham Tydeman—Forth Park Hospital, Fife NHS Board;Prof Peter Soothill—St Michael’s Hospital, Bristol;Dr Karen Brackley—Princess Anne Hospital, Southampton University Hospitals NHS Trust;Dr Pamela Loughna—Nottingham City Hospital NHS Trust;Dr Alan Cameron—Queen Mother’s Hospital, Greater Glasgow NHS Trust Board;Dr Sailesh Kumar—Queen Charlotte’s Hospital, Hammersmith Hospital NHS Trust and Dr Phil Bullen—St Mary’s Hospital Manchester.