A Single-blinded, Randomised Controlled Trial Comparing the Use of Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections (rUTI) and the Impact on the Vaginal and Urinary Microbiome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Postmenopausal women

• History of recurrent UTI (Defined as women who have suffered at least three episodes of symptomatic UTI within the preceding 12 months or two episodes in the last six months, or at least one episode of UTI requiring hospitalisation, or if previously prescribed prophylactic antibiotics for UTI, have completed a 3-month washout period without antibiotic prophylaxis)

• Able to give informed consent for participation in the trial

• Able and willing to adhere to a 17-month study period

Locations
Other Locations
United Kingdom
King's College Hospital
RECRUITING
London
Contact Information
Primary
Ana Sofia Da Silva
anasofiadasilva@nhs.net
0203 299 3568
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 48
Treatments
Experimental: Treatment Arm
Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch) will be administered intravaginally over a course of 5 cycles
Sham_comparator: Control Arm
Sham treatment -Participants receiving sham treatment will have the probes advanced in the same manner without the use of a laser energy device.
Sponsors
Leads: King's College Hospital NHS Trust

This content was sourced from clinicaltrials.gov