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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04096820
Eligibility Criteria:
Inclusion Criteria:
* Can provide written consent and willingness to comply with all aspects of study treatment and study requirements.
* Individuals who have had at least 3 episodes of a UTI in the past 12 months or 2 UTI episodes in the past 6 months. At least one of the UTI episodes must be associated with a positive urine culture with a traditional uropathogen including Escherichia coli, Proteus spp. Staphyloccous sp. Enterococcus sp. Klebsiella sp. or Pseudomonas aeruginosa.
* Post-menopausal for a minimum of 1 year or negative pregnancy test if participant is of child bearing potential and agreement to acceptable contraceptive use from Screening Visit 1 to final follow up visit if participant is sexually active. Medically acceptable methods of contraception include hormonal contraception (i.e. estrogen, and/or progesterone or preparations that contain a combination of these hormones), non-hormonal intrauterine device or double barrier method (i.e. condom with foam or vaginal spermicidal suppository, or diaphragm with spermicide) or vasectomy of sole sexual partner. Complete abstinence alone can be used as a method of contraception.
* Free of a urinary tract infection at the time of trial inclusion.
Exclusion Criteria:
* History of bladder tumours including uterine, cervical, vaginal or urethral cancer.
* Worrisome post-voiding residual (investigator's discretion).
* Infection related to urinary lithiasis.
* Any immunological disease requiring active therapy.
* Currently receiving Immunotherapy.
* Taking any prophylactic antibiotics at screening. Any prophylactic antibiotics must be stopped the day of the screening visit.
* Any known intolerance to the ingredients of the Uromune® Immunotherapy.
* Have any other condition or disease which, in the opinion of the investigator, could compromise participant safety or interfere with the participant's participation in the study or in the evaluation of the study results.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04096820
Study Brief:
Protocol Section:
NCT04096820