UTI-EXTERMINATE
Research type
Research Study
Full title
A Single-Blinded, Randomised Controlled Trial Comparing the Use of Intravaginal Laser Therapy to Sham in Post-Menopausal Women with Recurrent Urinary Tract Infections (rUTIs) and the Impact on the Microbiome. A Feasibility Study
IRAS ID
302037
Contact name
Ana Sofia Da Silva
Contact email
Sponsor organisation
King’s College London
Duration of Study in the UK
2 years, 0 months, 29 days
Research summary
Urinary tract infections (UTIs) are the most common outpatient infection with a prevalence of 20% in women over 65, compared with 11% in the overall population (Chu 2018). Intravaginal LASER therapy is an alternate non-hormonal treatment currently being used for the treatment of genitourinary syndrome of menopause (GSM). Intravaginal LASER functions by stimulating tissue repair and restoring normal vaginal function (Gambacciani 2017). Urogenital epithelial tissue thinning and changes to the vaginal and bladder microbiome that occurs following menopause can predispose to ascending UTIs, thus recurrent UTIs is a component of GSM. A recent network analysis of 29 randomised controlled trials (RCT), incorporating 8311 patients, found Laser to be safe and effective for the treatment of GSM (Li 2021). Provisional results using FemTouch®, fractional CO2 laser, appear promising with 9/12 (75%) of post-menopausal women UTI free at 12 months follow-up (Yang 2017).
Currently, to the best of our knowledge, there are no RCT studies assessing CO2-Laser on the incidence of UTI. This study aims to conduct a single-blinded RCT comparing the use of intravaginal CO2 laser therapy to sham in post-menopausal women with rUTIs and the impact on the microbiome. This is a single UK site study, based at King’s College Hospital. The research costs for the study have been supported by the British Society of Urogynaecology, Research Grant. The laser machine and consumables were donated by DEKA, some time ago and is now owned by the Trust and available for the duration of the study, with all safety checks carried out by the Trust.
Recurrent UTIs is a common and difficult to treat problem with limited treatment options, this study endeavours to expand the knowledge pool and provide alternative non-pharmacological options.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0238
Date of REC Opinion
16 Nov 2022
REC opinion
Further Information Favourable Opinion