Prenatal treatment of Lower Urinary Tract Obstruction

ISRCTN	ISRCTN53328556
DOI	https://doi.org/10.1186/ISRCTN53328556
Secondary identifying numbers	HTA 07/01/44; NN3007

Submission date: 28/04/2005
Registration date: 21/09/2005
Last edited: 02/08/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Prof Mark Kilby
Scientific

University of Birmingham
Department of Fetal Medicine
Birmingham Women's Hospital
Metchley Park Road
Birmingham
B15 2TG
United Kingdom

Phone	+44 (0)121 627 2778
Email	m.d.kilby@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information material can be found at http://www.pluto.bham.ac.uk/trial/Patient.htm.
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
Study acronym	PLUTO
Study objectives	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(s)	Nottingham Research Ethics Committee 2, January 2005, ref: 04/Q2404/89
Health condition(s) or problem(s) studied	Congenital bladder outflow obstruction
Intervention	Fetal vesico-amniotic shunt versus no shunt.
Intervention type	Other
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 study start date	01/09/2005
Completion date	30/09/2018

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	200
Key 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
Key exclusion criteria	Additional major structural or chromosomal anomaly
Date of first enrolment	01/09/2005
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Birmingham

Birmingham
B15 2TG
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Email	b.l.laverty@bham.ac.uk
Website	http://www.bham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Wellbeing of Women (UK)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date	01/01/1900
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/07/2007	Yes	No
Results article	results	02/11/2013	Yes	No
Results article	results	01/12/2013	Yes	No

Editorial Notes

02/08/2017: Recruitment end date changed to 31/12/2011 (estimation as main results published in 2013).
04/03/2016: Plain English summary added.
11/02/2009: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/09/2010 to 30/09/2018.
2. Health Technology Assessment Programme was added to the list of funders (initiated in September 2008)