GAG Layer replacement VS Urethral Dilatation. GUARDIAN
Research type
Research Study
Full title
To investigate and compare the efficacy of Urethral Dilatation versus Glycosaminoglycan layer replacement in the management of women with recurrent UTI.
IRAS ID
240855
Contact name
Christian Phillips
Contact email
Sponsor organisation
Hampshire Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 4 months, 13 days
Research summary
Recurrence of a Urinary Tract Infection (UTI) is defined as infection, following complete resolution of a previous UTI. Recurrent UTI (rUTI) is defined as 3 or more microbiologically confirmed UTI within 12 months. rUTI is an economic problem for healthcare services. rUTI is also detrimental to the quality of life (QoL) of women who suffer the disease. 61% of women who suffer rUTI report symptoms of depression and an associated decrease in their reported QoL scores. QoL was found to improve significantly with successful treatment.
E-coli is the most common bacteria causing UTI and 10% are thought to be antibiotic resistant. Consequently, new treatment strategies are required.
The Glycosaminoglycans (GAG) layer is thought to be instrumental as a defence mechanism against uro-pathogens. GAG’s are polysaccharides forming a gel like substance on the apical surface of the bladder wall and act as a barrier to uro-pathogens. There is now strong evidence that a reduction in the impermeability of the GAG layer is linked to rUTI.
Urethral dilatation is an alternative treatment to GAG replacement in the management of rUTI. It is a treatment option more widely adopted by Urologists, although there is a paucity of data to support its use (Rutherford 1988).
Currently there is no standardised strategy for the management of women with rUTI. Treatments vary between GAG layer replacement (intravessical therapy with hyaluronic acid and chondroitin sulphate) or a cystoscopy and urethral dilatation. Evidence for each regime varies greatly and is of poor quality.
This is a randomised study comparing GAG layer replacement with cystoscopy and urethral dilatation.REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0343
Date of REC Opinion
2 Jul 2018
REC opinion
Favourable Opinion