HATPIN v1.0
Research type
Research Study
Full title
Hyaluronate for the Treatment and Prevention of Recurrent Urinary Tract Infection in Women suffering Atrophic Vaginitis
IRAS ID
257957
Contact name
Christopher Harding
Contact email
Sponsor organisation
Newcastle Joint Research Office
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
In post-menopausal women, atrophic vaginitis causes dyspareunia (pain during intercourse), vaginal dryness, and vaginal irritation. It is often implicated as a causative factor, and may increase susceptibility to recurrent urinary tract infections (rUTIs). Annually, UTI incidence is 3% and of those affected, 5% will suffer rUTI, rising to 13% in the over 60 population. This equates to over 300,000 of the adult female UK population annually affected by rUTI.
The most frequent treatment for rUTIs is low dose antibiotics, but this can cause bacteria to become antibiotic resistant which exacerbates the problem. Hence, alternative non-antibiotic based therapies that reduce the incidence of rUTI are needed. One treatment with this potential is hyaluronate, which is already in use clinically and
is common in products such as face creams. Hyaluronate is currently used in the form of a vaginal cream to treat vaginal atrophy, and as a bladder instillation to treat rUTI. However, each treatment has only been analysed for its specific clinical use, e.g. vaginal hyaluronate has been analysed for its effect on atrophy but not on rUTI.This study aims to recruit patients suffering from both vaginal atrophy and rUTI and split them into two groups – one receiving hyaluronate via a vaginal cream and the other via bladder instillation. Both groups will then be monitored for vaginal atrophy symptoms and UTI frequency. Alongside this, we will collect samples of urine and vaginal douches every 3 months to analyse the natural immune responses of the body, which naturally protect against infection. In addition, we will collect a blood sample and conduct DNA analysis of specific genes which are known to contribute to increased susceptibility to infection by bacteria. This study could potentially reduce antibiotic use whilst also treating two conditions simultaneously which cause significant detriment to quality of life.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0065
Date of REC Opinion
8 May 2019
REC opinion
Further Information Favourable Opinion