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

NCT06124820 | Active Not Recruiting

• 1 other identifier: 302037
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Urinary Tract Infection; Genitourinary Syndrome of Menopause

Keywords

UTI; Recurrent Urinary Tract Infection; Genitourinary Syndrome of Menopause; Laser; CO2 Laser; Microbiome

Outcome Measures

Primary Outcomes (1)

• To determine and compare the incidence of symptomatic antibiotic-treated UTI during the 6-month follow-up period after completion of allocated treatment

  Determined from the UTI history diary and cross-referenced with hospital and GP records

  6 months

Secondary Outcomes (17)

• UTI history diary

  18 months

• Vaginal Health Index Score (VHIS)

  18 months

• King's Health Questionnaire (KHQ)

  18 months

• International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)

  18 months

• International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)

  18 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch) will be administered intravaginally over a course of 5 cycles

Device: Deka SmartXide Touch C60 (MonaLisa Touch)

Control Arm

SHAM COMPARATOR

Sham treatment -Participants receiving sham treatment will have the probes advanced in the same manner without the use of a laser energy device.

Device: Sham

Interventions

Deka SmartXide Touch C60 (MonaLisa Touch) DEVICE

Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch)

Treatment Arm

Sham DEVICE

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

Control Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not willing to abstain from vaginal intercourse for 48 hours 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
• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monalisa Touch (SmartXide2 V2LR, DEKA, Florence, Italy)

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: November 9, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): October 8, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

GB (1)