Plain English Summary
Background and study aims
Fetal bladder outflow obstruction is a rare condition where an unborn baby (fetus) is unable to pass urine due to a blockage of the tube called the urethra. This may cause permanent damage to the baby's kidneys and can lead to poor lung development and physical deformities such as clubfoot. About half of the babies diagnosed with this problem before birth will die either before birth or in the newborn period. For several years, vesico-amniotic shunting has been offered as a treatment to relieve the obstruction. A vesico–amniotic shunt is a tube that it is inserted into the unborn baby’s bladder to drain the excess fluid. However, there is only weak evidence that it improves survival and kidney function in those treated. The aim of this study is to find out whether vesico-amniotic shunting improves outcomes for fetal bladder outflow obstruction.
Who can participate?
Fetuses with bladder outflow obstruction
What does the study involve?
Following an ultrasound diagnosis of fetal bladder outflow obstruction, the fetuses are randomly allocated to either receive a vesico-amniotic shunt or continue with conservative treatment without a shunt. Termination and miscarriage rates, survival, and bladder and kidney function are assessed at 4 - 6 weeks and 12 months, and continence is assessed at 5 years.
What are the possible benefits and risks of participating?
This study is a crucial step in establishing whether this procedure has a place in future fetal medicine practice.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
September 2005 to September 2018
Who is funding the study?
NIHR Health Technology Assessment Programme (UK)
Who is the main contact?
Prof. Mark Kilby
m.d.kilby@bham.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mark Kilby
ORCID ID
Contact details
University of Birmingham
Department of Fetal Medicine
Birmingham Women's Hospital
Metchley Park Road
Birmingham
B15 2TG
United Kingdom
+44 (0)121 627 2778
m.d.kilby@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/01/44; NN3007
Study information
Scientific title
A multi-centre randomised controlled trial comparing intra-uterine vesico-amniotic shunting versus not shunting in the treatment of congenital bladder outflow obstruction
Acronym
PLUTO
Study hypothesis
Does intra-uterine vesico-amniotic shunting for fetal bladder outflow obstruction improve perinatal morbidity and mortality in fetuses, compared to conservative management?
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/070144
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/51741/PRO-07-01-44.pdf
Ethics approval
Nottingham Research Ethics Committee 2, January 2005, ref: 04/Q2404/89
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information material can be found at http://www.pluto.bham.ac.uk/trial/Patient.htm.
Condition
Congenital bladder outflow obstruction
Intervention
Fetal vesico-amniotic shunt versus no shunt.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Perinatal mortality rates and renal function at 4 - 6 weeks and 12 months measured via:
1. Serum creatinine
2. Renal ultrasound
3. Need for dialysis/transplant
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2005
Overall trial end date
30/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Mother:
1. Written informed consent given
2. Able to understand information provided (use of interpreter may be required)
3. Singleton pregnancy
Foetus:
1. Evidence of bladder outflow obstruction from ultrasound imaging
2. No major extra genitourinary anomalies present
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
200
Participant exclusion criteria
Additional major structural or chromosomal anomaly
Recruitment start date
01/09/2005
Recruitment end date
31/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TG
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
b.l.laverty@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Wellbeing of Women (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/01/1900
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17567421
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23953766
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24331029
Publication citations
-
Protocol
Kilby M, Khan K, Morris K, Daniels J, Gray R, Magill L, Martin B, Thompson P, Alfirevic Z, Kenny S, Bower S, Sturgiss S, Anumba D, Mason G, Tydeman G, Soothill P, Brackley K, Loughna P, Cameron A, Kumar S, Bullen P, PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial., BJOG, 2007, 114, 7, 904-5, e1-4, doi: 10.1111/j.1471-0528.2007.01382.x.
-
Results
Morris RK, Malin GL, Quinlan-Jones E, Middleton LJ, Hemming K, Burke D, Daniels JP, Khan KS, Deeks J, Kilby MD, , Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial., Lancet, 2013, 382, 9903, 1496-1506, doi: 10.1016/S0140-6736(13)60992-7.
-
Results
Morris RK1, Malin GL, Quinlan-Jones E, Middleton LJ, Diwakar L, Hemming K, Burke D, Daniels J, Denny E, Barton P, Roberts TE, Khan KS, Deeks JJ, Kilby MD, The Percutaneous shunting in Lower Urinary Tract Obstruction (PLUTO) study and randomised controlled trial: evaluation of the effectiveness, cost-effectiveness and acceptability of percutaneous vesicoamniotic shunting for lower urinary tract obstruction, Health Technol Assess, 2013, 17, 59, 1-232, doi: 10.3310/hta17590.