PURSUIT
Research type
Research Study
Full title
Proper Understanding of Recurrent Stress Urinary Incontinence Treatment in Women: A Randomised Controlled Trial of Endoscopic and Surgical Treatment
IRAS ID
257547
Contact name
Marcus Drake
Contact email
Sponsor organisation
North Bristol NHS Trust, Research & Innovation
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
Research Summary
Proper Understanding of Recurrent Stress Urinary Incontinence Treatment in Women (PURSUIT): A Randomised Controlled Trial of Endoscopic and Surgical Treatment.
Women with recurrent stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently the interventions for recurrent SUI are surgical, or endoscopic bulking injection, procedures. These procedures are not always successful and there are longstanding symptoms and distress associated with a failed treatment. The current research in this field is not conclusive about the best therapy for recurrent SUI.
The NIHR-HTA funded PURSUIT trial will investigate whether the surgical operations of colposuspension, autologus urethral sling, midurethral tape or artificial urinary sphincter are a better treatment in terms of symptom severity than the endoscopic therapy of urethral bulking injections in women with recurrent SUI at one year after randomisation. In the surgery arm of the study the participants will receive one of the four operations mentioned above. Which operation they receive will depend on the underlying mechanism which caused their SUI (as determined by urodynamic/cystoscopy assessment) and the patient's preference following discussion with their surgeon. In the endoscopy arm, participants will receive injections of bulking agents.
Adult women with bothersome stress urinary incontinence symptoms after failed primary SUI surgery or bulking injections, where recurrent SUI is confirmed by urodynamic/cystoscopy testing will be recruited. Women will be recruited from urology and urogynaecology secondary/tertiary units in the UK. The study duration is 6 years, comprising 6 months set-up/site initiation, 2 years recruitment, 3 years follow-up, 6 months analysis/dissemination. The 6 month internal pilot phase at the start of recruitment will test ability to recruit/randomise (trial sites and women), with clear progression criteria to the main trial. The project started on 1st of April 2019 and the expected end date is 31st March 2025.Summary of Results
Urinary leakage with physical activity or stress urinary incontinence (SUI), affects about a quarter of women after pregnancy and at other times. Treatment options include surgery or a bulking injection into the bladder, but symptoms can continue after treatment, known as recurrent, or persistent, SUI. It is not known which treatment is best for women who have already had a treatment. This study aimed to establish whether an operation or endoscopic bulking injections are better for treating recurrent or persistent SUI.
The study aim was for 250 women across the UK with recurrent SUI to take part and recruitment started in January 2020. Fifty-five women from 15 hospitals were identified as suitable and 23 women consented to take part and were randomly allocated (by chance) to a treatment group (surgery or bulking injection). Women in the surgery group decided which operation to have in consultation with their doctor. Women were asked to complete questionnaires at the start of the study, and again later, covering general health, urinary symptoms, and the effect of those symptoms on everyday life. Some women were interviewed to explore their attitudes to the treatments and understand how they manage after having treatment. The most common reason women gave for not wanting to take part was that they had a treatment preference. Eleven women received their allocated treatment.
However, the COVID-pandemic and wider issues within the NHS made it impossible to identify enough suitable women and treatments were prevented for a long period so the study closed early in March 2023. Unfortunately, it is not possible to make conclusions from the results collected due to the low numbers of women in the study. When healthcare services return to normal it may be possible to re-start the study as women still encounter the problem of recurrent SUI.
REC name
South West - Frenchay Research Ethics Committee
REC reference
19/SW/0209
Date of REC Opinion
24 Oct 2019
REC opinion
Favourable Opinion