Condition category
Neonatal Diseases
Date applied
28/04/2005
Date assigned
21/09/2005
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.pluto.bham.ac.uk/

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 measures

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

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

30/09/2018

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

http://www.bham.ac.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes

04/03/2016: Plain English summary added. On 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)