Details of HTA project
Last updated: 21 May 2013 - Next update due: 28 May 2013
Research type: |
Primary Research (e.g. trial) |
Project title: |
The PLUTO Trial: Percutaneous shunting in Lower Urinary Tract Obstruction |
 Outputs in journals arising from this project
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Project ref: |
07/01/44 |
Cost: |
£440,865 |
Chief Investigator : |
Professor Mark David Kilby, Prof of Fetal Medicine & Deputy Head of School, Division of Fetal Medicine, University of Birmingham |
Project Website |
http://www.pluto.bham.ac.uk |
Start Date: |
September 2008 |
Estimated date of publication in HTA journal series: |
September 2013. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed. |
Plain English Summary |
01/01/03 |
Project Abstract: |
DESIGN: Multi-centre randomised controlled trial (RCT) embedded within a comprehensive cohort study, including evaluation of patient acceptability and cost effectiveness analysis. We aim to randomise 200 pregnancies to either percutaneous vesico-amniotic shunting or conservative management and a prospective registry of all non-randomised patients will be maintained. To confirm diagnosis of bladder obstruction using ultrasound and assess renal function, a number of anatomical and biochemical markers will be recorded at diagnosis and at each 4 weekly antenatal visit. These will enable a prognostic risk index to be constructed from the emerging data, which will be used to identify sub-groups of pregnancies that are most likely to benefit from shunting. Bayesian prior (and later, posterior) beliefs will be collected from a sample of clinicians, including both obstetricians and paediatricians, the data will be used in both data monitoring and analysis. This will be particularly useful given the rarity of lower urinary tract obstruction ( LUTO) and will be able to determine whether clinicians revise their beliefs in line with Bayes rule on completion of the trial. Qualitative research using semi-focused interviews will be undertaken to ascertain the influences on participants decision making and acceptability of the trial. Questionnaires will be used to assess acceptability of treatment once effectiveness is knwon . Resource use and cost data will be collected on all mothers/pregnancies in the trial. SETTING: Tertiary referral units for fetal medicine in the UK and international, in an outpatient setting. Already 13 centres have obtained ethics and research governance approval, a further 10 centres are undergoing this process. Furthermore many International centres have expressed willingness to take part in the study. HTA funds will be used to support UK centres. TARGET POPULATION: Pregnant women with a singleton pregnancy, ultrasound evidence of isolated bladder outflow obstruction and a male fetus. Female fetuses are excluded due to the differing aetiology of their disease. Fetuses with additional major structural or chromosomal anomaly will be excluded. HEALTH TECHNOLOGIES: The trial will assess safety, acceptability, effectiveness and cost-effectiveness of vesio-amniotic shunting (insertion of a pig-tail catheter into the bladder of the fetus to allow drainage of urine, monitoring with fortnightly ultrasound) compared to conservative management (fortnightly monitoring with ultrasound). A systematic review by our team on the effectiveness of vesico-amniotic shunting (Clark et al 2003) showed a lack of high quality evidence in this area with no existing randomised controlled studies. NICE issued guidance on this interventional procedure (no. 202) in December 2006 and encouraged entry to the PLUTO trial. MEASUREMENT OF COSTS AND OUTCOMES: Primary outcome measures will be perinatal mortality up to 28 days of delivery and renal function measured by serum creatinine at 6 weeks of age. Secondary outcome measures will include assessment of bladder and renal function via degree of reflux on MCUG (micturating cystourethrogram) and ultrasound appearances (ureteric dilatation, renal pelvis dilatation, bladder wall thickness) in the neonatal period. Other outcome measures will include termination and miscarriage rates, and resource use and cost. These outcome measures are obtained as part of standard practice. Results will be abstracted from the clinical records and entered onto a trial specific database. All outcomes will be collected again at 12 months and serum creatinine and cognitive development at 2 years. In addition, death, chronic renal failure and the need for dialysis or transplantation will reported spontaneously up to the age of 5 years. Bladder function and continence and quality of life will be assessed at 5 years through clinical examination and validated questionnaires to assess a composite outcome measure, disability free life year. The material costs of the intervention are small (cost of the shunt) compared to the costs of paediatric care for renal failure it is important however that when looking at cost-effectiveness all outcomes are considered. We will collect cost data on all key resources used in provision of care and will perform a cost-effectiveness analysis using short and long-term outcomes, including perinatal mortality. |
ISRCTN* number: | ISRCTN 53328556 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN53328556 |
Project Protocol: |
Project protocol (pdf format, 661 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1732 |
Outputs from this project
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