Ask to take part

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.

Contact Information:

Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women with Recurrent Urinary Tract Infections

RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women with Recurrent Urinary Tract Infections

Not Recruiting

Open to: FEMALE

Age: All

Medical Conditions

Infections
Communicable Diseases
Urinary Tract Infections
Recurrence


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Recurrent urinary tract infection (rUTI) is a common and difficult to treat problem with limited treatment option; postmenopausal women are disproportionately affected. The genitourinary syndrome of menopause (GSM) describes the broad spectrum of signs and symptoms caused by the loss of endogenous sex steroids. The combined effects of urogenital epithelial tissue thinning and changes to the vaginal and bladder microbiome can predispose to ascending UTIs. Recurrent UTIs is a component of GSM.

Intravaginal laser therapy has been shown to be safe and effective for the treatment of GSM, however, the role of laser for treatment of recurrent UTIs is unknown. We hypothesis that the incidence of UTI will be reduced as CO2 laser restores vaginal epithelium to a state similar to that of a pre-menopausal woman, preventing microtrauma, and increases Lactobacillus and normal flora (Athanasiou et al., 2016). Lactobacillus is considered the bacteria that helps keep the vagina healthy and infection free through its production of lactic acid which lowers vaginal pH, this more acidic environment may be protective from uropathogens.

We therefore aim to conduct a single-blinded, multi-centre, randomised controlled trial comparing the use of intravaginal CO2 laser therapy to sham in post-menopausal women with rUTIs and to determine the impact on the microbiome.

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:

Oct 2023 Oct 2026

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch)

Intervention Arm Group : Treatment Arm;

Intervention Type : DEVICE
Intervention Description : Participants receiving sham treatment will have the probes advanced in the same manner without the use of a laser energy device.

Intervention Arm Group : Control Arm;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • King's College Hospital
    London
    SE5 9RS


The study is sponsored by King's College Hospital NHS Trust




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: NCT06124820
Last updated 05 March 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.