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WELCOME TO THE FUTURE STUDY

Female Urgency, Trial of Urodynamics as Routine Evaluation; a superiority randomised clinical trial to evaluate the effectiveness and cost effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms

What is FUTURE?

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 refractory overactive bladder (OAB).

OAB affects 12-14% (12 in every 100 women) 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 (Urinary Leakage being unable to hold-on); 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 sacral nerve modulation/ stimulation (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.

The FUTURE study is funded by the National Institute for Health Research HTA programme. You can find out more about taking part in research here: http://www.nihr.ac.uk/get-involved/ok-to-ask.htm.

You can find out more information about OAB and options of treatments on the NICE website https://www.nice.org.uk/guidance/cg171.
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Can I take part?

You may be eligible to take part in FUTURE if:

  • you are female and aged 18 or over,
  • you have symptoms of overactive bladder for which conservative treatments (e.g. pelvic floor exercises and/or bladder training) and drug therapy have failed or have not been tolerated,
  • and you are being considered for second line treatment.

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If you would like to know more about FUTURE, including information about taking part please contact the study office at the University of Aberdeen on 01224 438405 or email future@abdn.ac.uk.

If you are interested in taking part, or have any questions?

Where can I take part?

NHS Grampian

Key people:

Investigator:

  • Dr Mohamed Abdel-fattah

Address:

Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
NHS Fife

Key people:

Investigator:

  • Dr Chu Chin Lim

Address:

Victoria Hospital
Hayfield Road
Kirkaldy
KY2 5AH
NHS Borders

Key people:

Investigator:

  • Dr Kate Darlow

Address:

Borders General Hospital
Melrose
Roxburghshire
TD6 9BS
North Bristol NHS Trust - coming soon

Key people:

Investigator:

  • Mr Hashim Hashim

Address:

Southmead Hospital
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
East Sussex Healthcase NHS Trust

Key people:

Investigator:

  • Mr Hosam Elhalwagy

Address:

Eastbourne District General Hospital
Kings Drive
Eastbourne
East Sussex
BN21 2UD
NHS Greater Glasgow & Clyde

Key people:

Investigator:

  • Dr Karen Guerrero

Address:

Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
Countess of Chester Hospital NHS Foundation Trust

Key people:

Investigator:

  • Dr Lorraine Dinardo

Address:

The Pennine Acute Hospitals NHS Trust

Key people:

Investigator:

  • Mr Zahid Hussain

Address:

Salford Royal NHS Foundation Trust

Key people:

Investigator:

  • Mr Chris Betts

Address:

Liverpool Women's NHS Foundation Trust - coming soon

Key people:

Investigator:

  • Miss Gillian Fowler

Address:

The Newcastle upon Tyne Hospitals NHS Foundation Trust - coming soon

Key people:

Investigator:

  • Dr Karen Brown

Address:

City Hospitals Sunderland NHS Foundation Trust - coming soon

Key people:

Investigator:

  • Miss Vivienne Kirchin

Address:

The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust

Key people:

Investigator:

  • Miss Ruth Doherty

Address:

South Tyneside NHS Foundation Trust

Key people:

Investigator:

  • Mr James Nwabineli

Address:

City Hospitals Sunderland NHS Foundation Trust - coming soon

Key people:

Investigator:

  • Miss Vivienne Kirchin

Address:

South Tees Hospital NHS Foundation Trust

Key people:

Investigator:

  • Mr Aethele Khunda

Address:

South Tees Hospital NHS Foundation Trust

Key people:

Investigator:

  • Mr Aethele Khunda

Address:

South Tees Hospital NHS Foundation Trust

Key people:

Investigator:

  • Mr Aethele Khunda

Address:

Sheffield Teaching Hospitals NHS Foundation Trust

Key people:

Investigator:

  • Mr Christopher Chapple

Address:

University College London Hospitals NHS Foundation Trust - coming soon

Key people:

Investigator:

  • Mr Jeremy Ockrim

Address:

Northampton General Hospital NHS Trust - coming soon

Key people:

Investigator:

  • Mrs Ami Shukla

Address:

Maidstone and Tunbridge Wells NHS Trust - coming soon

Key people:

Investigator:

  • Mr Rowan Connell

Address:

Northern Health & Social Care Trust

Key people:

Investigator:

  • Mr Turlough Maguire

Address:

Plymouth Hospitals NHS Trust

Key people:

Investigator:

  • Dr Anu Dua

Address:

NHS Lothian - coming soon

Key people:

Investigator:

  • Miss Voula Granitsiotis

Address:

Manchester University NHS Foundation Trust

Key people:

Investigator:

  • Dr Karen Ward

Address:

University Hospital Southampton NHS Foundation Trust

Key people:

Investigator:

  • Mr Ash Monga

Address:

Guy's and St Thomas' NHS Foundation Trust - coming soon

Key people:

Investigator:

  • Mr Arun Sahai

Address:

Hampshire Hospitals NHS Foundation Trust - coming soon

Key people:

Investigator:

  • Mr Christian Phillips

Address:

Bolton NHS Foundation Trust - coming soon

Key people:

Investigator:

  • Dr Bim Williams

Address:

Study news

Recruitment

10/500

Trial sites

Latest addition to sites:

University Hospital Southampton NHS Foundation Trust
Manchester University NHS Foundation Trust
Plymouth Hospitals NHS Trust
Northern Health & Social Care Trust

Key facts about the study and documents

What is this study about?

If you are eligible and would like to part in the FUTURE study, you will discuss the study with your consultant as well as the local research nurse. (please see ‘Where can I take part?’ to check if your local hospital is participating).

If, after reading the participant information sheet and receiving satisfactory answers to all your questions, you would like to take part, you will be asked to sign the study consent form and answer some questions about your health.


You will then complete the study questionnaire and bladder diary in the privacy of your own home. After this, your research nurse will randomise you into the study i.e. you will be allocated (in random) to receive Urodynamics or not.

We will follow your progress for 15 months and we will send you the study questionnaire through the post (or email if you prefer) at 3, 6 and 15 months. The questionnaires are returned to the study office in a prepaid envelope which we provide.

You can find out more information on OAB/Urodynamics here: http://www.baus.org.uk/_userfiles/pages/files/Patients/Leaflets/Urodynamics14.pdf

Key contacts

Click on cards to find out more

Organisation

This project was funded by the National Institute for Health Research Health Technology Assessment (HTA) programme and is run by the University of Aberdeen, in conjunction NHS-Grampian. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of National Institute for Health Research, NHS Grampian or University of Aberdeen. Please visit each organisation's website for more information.