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NCT06124820: UTIEXTERMINATE

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

Active, enrolled NA Last updated 10 March 2025
What this trial tests

NA trial testing Deka SmartXide Touch C60 (MonaLisa Touch) in Recurrent Urinary Tract Infection in 48 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 October 2023
Primary endpoint
8 October 2026
8 October 2026

Quick facts

Lead sponsorKing's College Hospital NHS Trust
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment48
Start date1 October 2023
Primary completion8 October 2026
Estimated completion8 October 2026
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

King's College Hospital NHS Trust

Who can join

Eligibility, female only, with Recurrent Urinary Tract Infection or Genitourinary Syndrome of Menopause. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Recurrent Urinary Tract Infection

Currently open trials in the same condition.

Other King's College Hospital NHS Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06124820.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing