Proper understanding of recurrent stress urinary incontinence treatment in women

Plain English Summary

Background and study aims
Urinary leakage with physical activity is called stress urinary incontinence (SUI), and it affects about a quarter of women after pregnancy. Until recently, the most common treatment was a surgical operation which helps to support the tube which takes urine from the bladder to the outside (urethra), called midurethral (mesh) tape. Unfortunately, symptoms can come back after treatment, this is called recurrent SUI. In some cases, symptoms may never have gone away, this is called persistent SUI. Current treatment options for recurrent or persistent SUI include:
1. Injections into the urethra to help it to seal when leaks might happen called endoscopic bulking injections. The injections are done from a tube outside the body.
2. Surgical operations include:
- A medical mesh tape is placed in the vagina to support the urethra (midurethral tape)
- A strip of the patient’s own tissue (taken from the tummy area) is used to support the urethra (autologous fascial sling)
- Stitches are used to lift the vagina so that it supports the urethra (colposuspension)
- An implant device is placed around the urethra to gently squeeze it and prevent leaking (artificial urinary sphincter)
It is not known which of these treatments is best for women who have already had an operation or injections for SUI. The aim of this study is to find out whether surgical operations or endoscopic bulking injections are better for treating recurrent or persistent SUI.

Who can participate?
Adult (18 years or older) women with recurrent or persistent SUI who have already had an operation or bulking injection for it

What does the study involve?
250 women are recruited to the study. Equal numbers of women join an endoscopic bulking injection group or a surgical operation group. Which group women join will be decided by chance (in a process called randomisation). Women in the surgical operation group decide which operation to have with their doctor. Women receive their treatment and aftercare at hospital as they would during normal NHS care and are asked to complete a questionnaire booklet at the start of the study and again 6 months, 1, 2 and 3 years later. The questionnaires cover general health, urinary symptoms and the effect of those symptoms on everyday life and sex life. The researchers audio-record consultations where the study is discussed with women and interview some women to see how research is explained and understand how women manage after their treatment.

What are the possible benefits and risks of participating?
Some people enjoy being part of research studies because of the close contact with research staff and the opportunity to share their opinions and experiences of their condition and treatments. Women will be offered a £10 voucher for completing their questionnaire at 1 year and another £10 voucher for completing their questionnaire at 3 years. There is no additional risk to normal NHS practice of the endoscopic bulking injections or surgical operations, and neither are new or experimental. Women taking part will have the same risks as anyone having treatment for recurrent SUI. This includes the possibility that symptoms may not improve as much as women would like. The risks and benefits of each treatment will be explained by the doctors, and women will be provided with relevant hospital leaflets.

Where is the study run from?
This study is sponsored by North Bristol NHS Trust. The Bristol Randomised Trials Collaboration (as part of the Bristol Trials Centre) at the University of Bristol is responsible for managing the study. The researchers aim to run the study in 20 NHS hospitals across the UK.

When is the study starting and how long is it expected to run for?
April 2019 to October 2022

Who is funding the study?
National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Programme (UK)

Who is the main contact?
Dr Caroline Pope
pursuit-trial@bristol.ac.uk

Study website

Contact information

Dr Caroline Pope
Public

Bristol Trials Centre (BRTC)
Bristol Medical School
University of Bristol
Room 3.12, Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

ORCID ID	0000-0002-7856-6042
Phone	+44 (0)117 9287219
Email	pursuit-trial@bristol.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

24/11/2023: The study status was changed to 'Stopped'.
06/02/2023: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 31/07/2022 to 11/07/2022.
3. The overall end date was changed from 31/03/2025 to 04/10/2022.
4. The study closed early (early withdrawal of funding) on the basis of not being feasible.
04/08/2022: Publication reference added.
14/07/2022: The trial participating centres were added: Royal Cornwall Hospitals NHS Trust, East Lancashire Hospitals NHS Trust, Bradford Teaching Hospitals NHS Foundation Trust,
The Leeds Teaching Hospitals NHS Trust, Stockport NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, Liverpool Women's NHS Foundation Trust, Bedfordshire Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust
21/07/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2021 to 31/07/2022.
2. The trial participating centre "South Tees Hospitals NHS Foundation Trust" has been added.
01/02/2021: Cambridge University Hospitals NHS Foundation Trust was added as a trial participating centre.
30/10/2020: Recruitment for this study is no longer paused as of 22/09/2020.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
18/12/2019: Trial's existence confirmed by the NIHR.