Status:
ACTIVE_NOT_RECRUITING
RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women with Recurrent Urinary Tract Infections
Lead Sponsor:
King's College Hospital NHS Trust
Conditions:
Recurrent Urinary Tract Infection
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
Phase:
NA
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 m...
Detailed Description
Urinary tract infections (UTIs) are the most common outpatient infection with a prevalence of 20% in women over 65, compared with 11% in the overall population (Chu and Lowder, 2018). The genitourina...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06124820
Start Date
October 1 2023
End Date
October 8 2026
Last Update
March 10 2025
Active Locations (1)
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1
King's College Hospital
London, United Kingdom, SE5 9RS