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

What this trial studies

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.

Conditions in scope

• Recurrent Urinary Tract Infection
• Genitourinary Syndrome of Menopause

Interventions

• Deka SmartXide Touch C60 (MonaLisa Touch) (Device) — Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch)
• Sham (Device) — Participants receiving sham treatment will have the probes advanced in the same manner without the use of a laser energy device.

Who can join

Women only · Adults (Child, Adult, Older Adult)

Inclusion criteria

• 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

Exclusion criteria

• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2023-10-01
• Primary completion: 2026-10-08
• Last update posted: 2025-03-10
• First posted: 2023-11-09

Sponsor & contact

Lead sponsor: King's College Hospital NHS Trust (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• To determine and compare the incidence of symptomatic antibiotic-treated UTI during the 6-month follow-up period after completion of allocated treatment (6 months)
  Determined from the UTI history diary and cross-referenced with hospital and GP records

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.