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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Other diseases of urinary system
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Device;
You can take part if:
You may not be able to take part if:
• Not willing to abstain from vaginal intercourse for one week following laser-therapy • Use of vaginal hormonal therapy in the three months before study start • History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during physical screening exam (e.g., deficient perineal body) • Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection • Active or history of genital herpes • History of lichen sclerosis • History of radiotherapy for cervical or uterine cancer • A medical condition that may interfere with participants’ compliance with the protocol • Women with correctable urinary tract abnormalities that are considered to be contributory to the occurrence of rUTI • Women taking Methenamine Hippurate and unable to undergo a three-month washout period • Undiagnosed genital bleeding • Women who self-catheterise, or have an indwelling/suprapubic catheter • Unable to give informed consent • Inability to speak or read English
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by King's College London and funded by THE UROLOGY FOUNDATION .
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for Trial ID: CPMS 54222
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