Prenatal treatment of Lower Urinary Tract Obstruction
| ISRCTN | ISRCTN53328556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53328556 |
| Protocol serial number | HTA 07/01/44; NN3007 |
| Sponsor | University of Birmingham (UK) |
| Funders | Health Technology Assessment Programme, Wellbeing of Women (UK) |
- 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
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
Contact information
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 |
|---|---|
| m.d.kilby@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
Perinatal mortality rates and renal function at 4 - 6 weeks and 12 months measured via: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
B15 2TG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/11/2013 | Yes | No | |
| Results article | results | 01/12/2013 | Yes | No | |
| Protocol article | protocol | 01/07/2007 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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)
