Compliance with Uresta (CURE) study
Research type
Research Study
Full title
Compliance with Uresta (CURE) study
IRAS ID
254704
Contact name
Patrick Campbell
Contact email
Sponsor organisation
Imedicare
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Stress urinary incontinence (SUI) is accidental leakage of urine with laugh, cough, sneeze or physical exertion. SUI is a common condition affecting almost 1 in 3 women. Management options include pelvic floor muscle training (pelvic floor exercises), temporary vaginal support devices or surgery. In recent years many women underwent a surgical procedure using a plastic mesh tape to treat incontinence. These operations have recently been suspended due to concerns about mesh complications. Traditional non-mesh operations are still available but are bigger operations with longer recovery time. Women who only leak urine during exercise may not wish to embark on such major surgical intervention. Non-surgical, low-risk treatment options, such as vaginal support devices, are becoming increasingly popular. These devices are inserted into the vagina by women prior to physical activity and removed afterwards. They represent a very effective treatment option for this group of patients.
Unfortunately many of the new non-surgical treatment options are not available on NHS prescription and women have to purchase these themselves. In the UK, only one device is available on prescription - the Contiform device. A new device called Uresta has been shown to be effective in clinical studies and claims to be more effective and better tolerated than the existing intra-vaginal devices. Anecdotal reports from patients suggest the device is easier to insert and remove than the Contiform device and this was supported by a recent study where physiotherapists tried using the device themselves. In order for the Uresta device to become available to women on the NHS, a UK based study is required to confirm the effectiveness of the device and that women will continue to use it for at least 1 year.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0446
Date of REC Opinion
28 Aug 2019
REC opinion
Favourable Opinion