Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT06124820
Eligibility Criteria:
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
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT06124820
Study Brief:
Protocol Section:
NCT06124820