2016-2017 - FUTURE: A new research study for women with Overactive Bladder (OAB)
What is the FUTURE study?
FUTURE is a research study looking at how useful a special bladder test called ‘Urodynamics’ is at improving the treatment results for women affected by overactive bladder (OAB).
Why is this research important?
OAB affects 12-14% of the adult female population in the UK. Symptoms include increased frequency (going to pass urine more frequently); urgency (being unable to hold-on); urgency incontinence (UUI); and waking up at night to pass urine. Although rarely life-threatening, OAB can have a considerable negative impact on patients’ quality of life, restricting their social life and ability to work, and up-to social isolation in severe cases.
OAB is first treated with lifestyle changes (such as reducing caffeine intake); pelvic floor exercises; bladder training and certain medications. Unfortunately these treatments do not work in 25-40% of patients (i.e. refractory OAB). These patients may be offered second line treatments such as injections of BOTOX into the bladder wall or SNM (an implant in the buttock which aim to regulate the bladder nerves in the lower spine).
Before recommending second line treatments, doctors are advised to perform a diagnostic invasive test called “Urodynamics” to confirm the diagnosis. The test involves passing a thin tube into the bladder and another one into the back passage to measure the bladder activity and episodes of urinary incontinence (UI).
Patients often find Urodynamics embarrassing and uncomfortable and some get cystitis after the test. When asked, patients felt the test could be justified if it improves the treatment outcomes. However, in almost 40% of patients, Urodynamics does not show the underlying cause of the bladder problem and therefore is unable to guide doctors and patients in their decision making.
The FUTURE study therefore aims to assess whether routinely performing Urodynamics, in addition to the standard comprehensive clinical assessment, improves the outcome of treatments in women with refractory OAB compared to comprehensive clinical assessment only. We also want to assess whether doing the test on everybody makes the best use of NHS resources.
What is involved for study participants?
The decision whether women receive the Urodynamics test over and above comprehensive clinical assessment, will be decided by a computer in random fashion (i.e. with no input from the patient or doctor). Patients in the “Comprehensive Clinical Assessment Only” group will receive the standard clinical assessment as per local NHS practice. Patients in the “Urodynamics and Comprehensive Clinical Assessment” group will receive the Urodynamics test in addition to the comprehensive clinic assessment.
Postal questionnaires will be sent to all participants at 3, 6 and 15 months after being allocated to one of the two groups. These questionnaires ask about bladder symptoms, how they impact on quality of life, and participants views and experience with the treatment pathways received.
Are there any possible benefits or disadvantages to taking part?
Participants may not benefit personally from taking part in the FUTURE study. However, they will be directly helping clinicians, future patients and decision-makers within the NHS to decide on the most effective assessment and treatment pathway for women with refractory OAB.
In addition, we do not think that there are disadvantages or risks to participants in taking part in this study. Whichever group they are allocated to, the tests and assessments will be performed by competent and trained clinicians. However it is important to note that there are risks associated with every test or treatment, and as part of routine clinical care, participants will be well informed of these potential risks. Steps are always taken to ensure that these risks are minimised.
Want to know more?
To find out more about the FUTURE study, please visit the website at https://w3.abdn.ac.uk/hsru/FUTURE/Public/Public/index.cshtml
10/12/15. Check out this article on Examiner.com :
Here is a new research study http://www.examiner.com/article/panic-disorder-linked-with-interstitial-cystitis-research-suggests
"Research suggests a potential genetic linkage between interstitial cystitis and panic disorder in certain families. In general, there is the possibility of a broad syndrome including bladder problems, chronic headachces/migraines, thyroid disorders and/or mitral valve prolapse. In 19 families with panic disorder, one genetic marker, namely, D13S779 on chromosome 13 was correlated with such a group of symptoms. Indeed, those with interstitial cystitis had a significantly higher lifetime prevalence of panic disorder, even when controlling for age and sex. First-degree relatives of those with interstitial cystitis were likewise more likely to have thyroid disorder, urologic problems, and panic disorder. The correlation between these otherwise disparate disorders suggest the possibility of a genetic linkage"
BHUK Members are asked to take part in the following studies in 2015:-
1. ALTAR study.
Full title of project: 13/88/21 ALternatives To prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women (ALTAR study); a pragmatic randomised trial of urinary antiseptic versus prophylactic antibiotic.
Chris Harding - I am a Urologist in Newcastle-u-Tyne with an interest in clinical research. I have recently been awarded £980K by the NIHR HTA scheme to carry out some research into female UTI’s – the ALTAR study. I am making initial contact to enquire whether you would like to be involved with this study as PPI rep on the trial steering committee. I am keen for a big patient organisation such as yourselves to be represented and would like to offer BHUK first refusal. You will probably want to know a bit more about the trial and so if you are keen I can send you the detailed project plan – alternatively if you want to have a chat over the phone.
Mr C K Harding, Consultant Urological Surgeon, Freeman Hospital
BHUK Member Jane Staplford is the patient representative on the ALTAR study group. More information to follow in 2016.
2. Uromune Steering Group.
BHUK have been asked to represent the Patient at an Advisory Board Meeting to discuss recent developments in the management of Recurrent UTI.
'We shall happily welcome 2 BHUK Foundation members but ideally these should possess very good understanding of Urinary tract infections, it management, antibiotics resistance etc. and are able to contribute well in the meeting'
The first meeting was attended in September by Suzanne Evans and Susan Yates. BHUK views were well recieved. More meetings due in 2016.