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The FUTURE study

  • Research type

    Research Study

  • Full title

    Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study); 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.

  • IRAS ID

    223787

  • Contact name

    Mohamed S Abdel-fattah

  • Contact email

    m.abdelfattah@abdn.ac.uk

  • Sponsor organisation

    University of Aberdeen

  • Duration of Study in the UK

    3 years, 11 months, 30 days

  • Research summary

    Overactive bladder (OAB) affects 12-14% of the adult female population in the UK. Symptoms include urgency (being unable to hold-on); urgency incontinence (UUI); increased urinary frequency during day and night. The cause of OAB may be uncontrollable contractions of the bladder called detrusor overactivity. OAB can have considerable impact on quality of life, restricting social life, ability to work, and social isolation in severe cases. OAB is treated first with lifestyle changes; pelvic floor exercises; bladder training and certain medications. These treatments do not work for 25-40% of patients (i.e. refractory OAB). These patients can be offered second line treatments such as injections of BOTOX into the bladder wall or SNM (an implant in the buttock which stimulates 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 thin tubes into the bladder and the back passage to measure the bladder activity and episodes of urinary incontinence (UI). Patients can 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, for 1/3 of patients, Urodynamics may not show the cause of the OAB/UI and patients may not be offered treatments, which may otherwise improve their condition. \nWe propose a study to evaluate whether Urodynamics in patients with refractory OAB improves their treatment outcomes. Patients who fit the criteria for the study and who agree to take part will be randomly allocated to have Urodynamics plus comprehensive clinical assessment or comprehensive clinical assessment only. In both groups, women will be offered standard treatments for refractory OAB as per defined treatment pathways and in accordance with the national guideline. \nWe aim to recruit 1096 participants across 40 hospitals. The main outcome of the study will be participant reported treatment success measured 15 months post randomisation.\n

  • REC name

    North of Scotland Research Ethics Committee 2

  • REC reference

    17/NS/0018

  • Date of REC Opinion

    27 Mar 2017

  • REC opinion

    Further Information Favourable Opinion