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The Children’s Network provides expert support for both medicinal (CTIMP) and non-medicinal (Non-CTIMP)trials, which are funded by an NHS Research Scotland Eligible Funder list. All Scottish research ongoing within the network is registered on the UK Clinical Research Network portfolio database. If you would like to find out more about our portfolio or are interested in recruiting to any of our studies please contact email@example.com.
BOTOX in the treatment of urinary incontinence in young adults
Daytime urinary incontinence in children and young adults is a common problem with which can negatively impact on an individual’s quality of life. Adverse effects can include feelings of social isolation, depression and disturbed sleep.
Causes and standard treatment
The most frequent cause of daytime urinary incontinence, which predominately but not exclusively affects girls, is overactivity of the bladder detrusor muscle (OAB). Standard treatment consists of identifying and eliminating risk factors (poor fluid intake, poor toileting habits, constipation, stimulant intake e.g. caffeine), followed by anticholinergic medication if simple measures fail. In addition, Posterior Tibial Nerve Stimulation (Neuromodulation) is a useful alternative option. While this is often successful, some children are unresponsive to all options or have significant side effects from medication.
In adult practice a standard approach would be to use an intravesical injection of Botulinum toxin (Botox A). While this is a very effective treatment, there is a risk of temporary urinary retention that requires a period of intermittent catheterisation until it resolves. Botox A is licensed for treating OAB in adults but not currently in children.
The OAB study is looking at young adults aged 12-17 with OAB who have tried conventional treatment without success. After appropriate consent and screening the study randomises patients to receive either 25, 50 or 100 IU of Botox A injected directly into the bladder wall. The primary end point is number of wetting episodes with a secondary end point of voiding episodes. Quantifying the risk of urinary retention is also an important end point.
The OAB study is a multinational randomised trial with the patient and surgeon blinded to the dose of Botox A administered. The research is being co-ordinated in Aberdeen by the ScotCRN and is funded by Allergan, the manufacturer of Botox A, as part of their licencing agreement, and is a multinational randomised trial with the patient and surgeon blinded to the dose of Botox A administered.
It is thought that obesity in mothers preceding pregnancy, and the consequently altered maternal mood during pregnancy through hormonal changes, may affect a child’s early cognitive and behavioural development. The HAPPY study (Hormone and Inflammation in Pregnancy Study- Parents and Young) will follow up around 300 mothers and babies who took part in a longitudinal, case-cohort HIP study between 2008 and 2013 in order to understand whether changes in body weight, hormones and inflammatory markers in pregnancy can influence the current health of the mother and child.
Consenting mothers and their children will attend The Children’s Clinical Research Facility at the Royal Hospital for Sick Children, Edinburgh where they will complete lifestyle and wellbeing questionnaires and participate in cognitive /developmental assessments: the Marshmallow Test which analyses a child’s self-control, and Head-Toe-Knee-Shoulder (HTSK) tasks which test behavioural self-regulation. Buccal swab samples will be taken from the children in order to test cortisol (stress hormone) and glucose levels. DNA will also be extracted from blood samples for analysis of epigenetic modifications (changes in the gene ‘signature’) in candidate genes which are thought to be important in growth.
For a look behind the scenes of the HAPPY study drop an email to Theresia Mina, the PhD student running this study on T.H.Mina@sms.ed.ac.uk.
The HAPPY study is funded by Tommy's the Baby Charity and NHS Lothian.
What is TrialNet
Type 1 Diabetes TrialNet comprises a network of 18 clinical centres throughout the United States, Canada, Finland, United Kingdom, Italy, Australia, and New Zealand and is dedicated to the study, prevention, and early treatment of Type 1 diabetes. In the UK TrialNet is led from the coordinating centre in Bristol with 11 affiliate sites nationwide, including Aberdeen, with a further 6 new sites currently in set up.
TrialNet is currently conducting 3 types of research:
- Natural History Study: looking at how type 1 diabetes develops in those individuals identified as being at risk of contracting the disease.
- Diabetes Prevention Studies: testing therapies that may delay or prevent the onset of type 1 diabetes.
- Diabetes Intervention Studies: testing therapies to preserve insulin secretion in people recently diagnosed with type 1 diabetes.
Research staff at the Royal Aberdeen Children’s Hospital (RACH) are currently involved in the Natural History Study (TN01) and the Oral Insulin Study (TN07).
Natural History Study (TN01)
TrialNet screens relatives of people with type 1 diabetes as they have about 15 times greater risk for developing the disease than people with no family history. Type 1 diabetes develops when the body creates proteins called autoantibodies which destroy insulin producing cells in the pancreas. These autoantibodies can be found in the blood up to 10 years before someone is diagnosed with diabetes and can be detected by a blood test.
Oral Insulin Study (TN07)
A previous study called DPT-1 has suggested that oral insulin might delay or prevent type 1 diabetes in some people found to be at risk. TrialNet is now testing oral insulin (insulin taken by mouth) to see if this is the case in individuals who tested positive in the blood test.
The Natural History Study has now recruited 118,235 people worldwide. Of these, 3427 have continued to monitoring (2.9%). UK recruitment in April 2013 reached a new high of 152 with Aberdeen recruiting 10 new participants! 324 participants worldwide have now fulfilled the eligibility requirements for entry into the Oral Insulin study, with 4 of those coming from the UK.
There are plans to expand the Natural History study to compare blood collection by venous (obtained by puncturing a vein) and capillary routes (from the heel or fingertip) in Natural History Study participants. A new prevention study is also being designed which plans to look at using Trichuris suis (whipworm) to normalize the immune system of those with autoimmune disorders.
For more information about the TrialNet studies being conducted in Aberdeen please email Victoria Thomson at firstname.lastname@example.org.