Condition category
Neonatal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

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

Trial website

Contact information



Primary contact

Prof Mark Kilby


Contact details

University of Birmingham
Department of Fetal Medicine
Birmingham Women's Hospital
Metchley Park Road
B15 2TG
United Kingdom
+44 (0)121 627 2778

Additional identifiers

EudraCT number 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



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:
Protocol can be found at:

Ethics approval

Nottingham Research Ethics Committee 2, January 2005, ref: 04/Q2404/89

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Patient information material can be found at


Congenital bladder outflow obstruction


Fetal vesico-amniotic shunt versus no shunt.

Intervention type



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


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Written informed consent given
2. Able to understand information provided (use of interpreter may be required)
3. Singleton pregnancy

1. Evidence of bladder outflow obstruction from ultrasound imaging
2. No major extra genitourinary anomalies present

Participant type


Age group




Target number of participants


Participant exclusion criteria

Additional major structural or chromosomal anomaly

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
B15 2TG
United Kingdom

Sponsor information


University of Birmingham (UK)

Sponsor details

B15 2TT
United Kingdom

Sponsor type




Funder type


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


United Kingdom

Funder name

Wellbeing of Women (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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:
2013 results in:
2013 results in:

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)