
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.
The UK study is the world’s first randomised controlled trial of the clinical and cost-effectiveness of invasive urodynamics testing.
Lead researcher Professor Mohamed Abdel-Fattah is Director of the Aberdeen Centre for Women’s Health Research, University of Aberdeen.
Abdel-Fattah 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.”
The study focused 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 per cent of women reporting their symptoms were ‘very much’ and ‘much’ improved in the urodynamics group versus 22.7 per cent 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 per cent 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.
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.
Professor Benoit Peyronnet is Professor at the Rennes University Department of Urology, France, and member of the EAU Scientific Congress Office.
The researcher 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.”
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