Women with ongoing urinary incontinence could avoid invasive bladder pressure tests, as new research shows that a range of non-invasive assessments work just as well in guiding treatment.
Led by researchers at the University of Aberdeen, the findings of the FUTURE Trial are presented today (Saturday 22 March 2025) at the European Association of Urology (EAU) Congress in Madrid and published in The Lancet.
The UK study is the world's first randomised controlled trial of the clinical and cost-effectiveness of invasive urodynamics testing. It focuses on a group of women with particular types of overactive bladder or urge urinary incontinence that do not respond well to initial treatments.
These first-line treatments include pelvic floor exercises, bladder retraining and drug treatments, and referral to invasive urodynamics testing can determine whether their condition is caused by an overactive detrusor muscle in the bladder. The tests are recommended by UK and European guidelines, before proceeding to invasive treatments like sacral nerve stimulation or Botulinum Toxin-A injection directly into the bladder wall.
For this group of women, invasive urodynamics testing has been commonly used in clinical practice for over 40 years. It assesses how well the bladder stores and releases urine and can be an uncomfortable test for many. The tests include filling the bladder with water through a catheter inserted into the bladder. Another catheter is inserted into the vagina or rectum to measure the pressures inside the bladder and abdomen.
Comprehensive Clinical Assessment (CCA) for female incontinence are thought to reveal equally useful information to guide treatment without the need for invasive testing. CCA includes a detailed medical questionnaire, a thorough physical examination, a bladder diary, and a "cough test" to assess for stress incontinence. It may also involve urinalysis and a test to measure the amount of urine left in the bladder after urination.
To determine whether urodynamics testing would lead to patients reporting successful outcomes from their treatment, compared to treatment plans guided by CCA, the FUTURE Trial recruited 1099 women across 63 UK hospitals.
Women were included in the trial if they had an overactive bladder or urinary incontinence, predominantly characterised by sudden urgency to urinate, that was not responding to first-line treatments. Participants were randomised to either undergo invasive urodynamics testing plus a CCA, or just a CCA.
During a 15–24-month follow-up period, participants were asked to report on the success of the treatment offered. The trial found no significant difference between the two forms of assessment, with 23.6% of women reporting their symptoms were 'very much' and 'much' improved in the urodynamics group versus 22.7% in the CCA only group – showing that both assessments deliver similar patient reported outcomes.
Women who only underwent CCA also reported earlier improvement in their symptoms. 13% of women undergoing urodynamics had their diagnosis changed to urodynamic stress incontinence and their treatment plan changed accordingly.
The researchers suggest that clinicians can now be more selective in determining who to refer to invasive urodynamics tests.
Lead researcher Professor Mohamed Abdel-Fattah, Director of the Aberdeen Centre for Women's Health Research, University of Aberdeen, said: "Invasive urodynamics tests can be embarrassing and uncomfortable procedures. For many women who are struggling with finding a treatment that works for this type of urinary incontinence, our trial shows they no longer have to go through that experience to achieve an improvement in their symptoms and quality of life.
"While women who underwent invasive urodynamics testing received more tailored treatments based on the test result, this did not translate to better patient reported success rates following treatments, better improvement in women's quality-of-life, or less adverse events.
"It's clear that in this cohort of women, comprehensive clinical assessments alone provide enough information to help design a successful treatment plan for those who aren't responding to first-line treatments, and so clinicians can be far more selective about who is referred for urodynamics."
A CCA can be carried out by a specialist nurse or hospital doctor and does not require specialist equipment. Invasive urodynamics tests, however, involve referral to a specialist clinic, involves several staff and dedicated equipment, and can mean waiting for many weeks or months to be seen.
Following an economic evaluation, the researchers concluded that urodynamics testing for this group of women was not value for money, based on the UK's National Institute for Health and Care Excellence cost-effectiveness threshold of £20,000 per extra year of good health.
Commenting on the results of the FUTURE Trial, Professor Benoit Peyronnet, Professor at the Rennes University Department of Urology, France, and member of the EAU Scientific Congress Office, said: "Many European countries have long waiting lists for urodynamics testing, and the invasive tests can be an unpleasant experience for women. The FUTURE Trial's findings are very important as they are the first to show that invasive urodynamics testing could be avoided in a subgroup of patients and the outcomes for women – based on their own reports of whether their treatment is successful – could be just as good.
"However, in busy clinical settings, there may not be time to undertake the series of comprehensive assessments carried out in the FUTURE trial, so invasive urodynamics tests may still be valuable and important in some settings - and especially in some groups of patients. We also need to be mindful that this is just a two-year study based on patient reported outcomes, so while the evidence is of high enough quality to influence practice, the results of a longer-term follow-up trial will be very interesting to see."
The FUTURE Trial was funded by the National Institute for Health and Care Research Health Technology Assessment Programme. A five-year follow-up trial assessing longer-term outcomes and cost-effectiveness of urodynamics is currently underway by the researchers.
