(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.

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

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 frequency (going to pass urine more frequently); and waking up at night to pass urine. The cause of OAB may be uncontrollable contractions of the bladder called detrusor overactivity. 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. The health-related costs for management of OAB/UUI poses a significant burden and were estimated at approximately 7 billion in 2005 for 6 European countries including the UK OAB is first treated with lifestyle changes (such as reducing caffeine intake); pelvic floor exercises; bladder training and certain medications; 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 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 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 about one third of the patients, Urodynamics may not show the cause of the OAB/UI and patients may not be offered treatments, which could otherwise improve their condition. We propose a study to evaluate Urodynamics in patients with refractory OAB who wish to receive further treatment. Patients who fit the criteria for the study, will be asked to take part at many hospitals in the UK to find out whether or not undergoing Urodynamics improve the subsequent treatment outcomes. We will also look at whether the tests provide value for money for the NHS. Patients who agree to take part will be randomly assigned to undergo Urodynamics or Clinical assessment only. In both groups, women will be offered standard treatments for refractory OAB as per clearly defined treatment pathways which were developed in line with the national guidelines. The outcomes of treatment will be measured up to 5-years after they joined the study. Patients will be asked to fill in questionnaires about their urinary symptoms; quality of life; further treatment received and any adverse events. We will compare the results of treatment for patients who received Urodynamics with those who did not. There are no perceived risks for the patients by participating in the study. Patients will not undergo any invasive tests, for research purposes, within the study. The study team includes experts in Urology & Gynaecology from all corners of the UK, working with an internationally renowned clinical trials unit, statisticians, medical engineer, qualitative researchers and health economists. The Bladder and Bowel Foundation (a large Patient support group) is a joint co-applicant and has participated in the development of the study. The Cystitis & OAB foundation will further advise on patients' perspective.