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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT03981458
Eligibility Criteria:
Inclusion Criteria:
* • Postmenopausal women not receiving hormonal supplementation.
* Women with atrophic vaginitis and rUTI who, in consultation with a clinician, have decided that either hyaluronate treatment (intravesical or vaginal) is an appropriate option.
* Women who have suffered at least three episodes of symptomatic UTI within the preceding 12 months or two episodes in the last 6 months.
* Able to attend a urology clinic for catheterisation on a regular basis (initially weekly) to initiate intravesical bladder instillation treatment.
* Able to apply vaginal hyaluronate gel at home every 3 days.
* Able to give informed consent for participation in study.
* Able and willing to adhere to a 9-month study period.
Exclusion Criteria:
* • Postmenopausal women receiving hormonal supplementation (e.g. HRT or oestrogen creams).
* Women unable to use hyaluronate e.g. due to previous sensitivity issues.
* Women with urinary tract abnormalities that are considered to be contributory to the occurrence of rUTI.
* Presence of symptomatic UTI - this will be treated and symptoms resolved prior to randomisation.
* Women currently using hyaluronate for either treatment of atrophic vaginitis or prevention of recurrent UTI or women who have used either study treatment in the preceding 12 months.
* Women receiving prophylactic antibiotics.
* Catheter usage.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
90 Years
Study:
NCT03981458
Study Brief:
Protocol Section:
NCT03981458