A Clinical Trial to see if a herbal medicine, Urox can prevent the recurrence of a urinary tract infections (UTIs) and cystitis.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: UROX® is a herbal therapeutic good, a proprietary combination of three herbal extracts, listed with the Australian Therapeutics Goods Administration, AUSTL400655. URO Xcontains Horsetail 150mg, Lindera 150mg and Crateva 120mg in one capsule. Dose: 2 capsules a day in the morning for 6 months Compliance: 4 weekly follow up (online) visits will be conducted to assess number of capsules left for each participant for the 6 months. Blood tests will be conducted at screening and at 6 months, urine tests will be conducted at each acute episode from a participant. CONDITION: Infection ‐ Studies of infection and infectious agents Recurrent Urinary tract infections;Recurrent Cystitis; ; Recurrent Urinary tract infections ; Recurrent Cystitis Renal and Urogenital ‐ Other renal and urogenital disorders PRIMARY OUTCOME: Incidence of UTIs, and/or cystitis at 6 months. This is a composite primary outcome as the acute episode won't be assessed for cystitis although the participant maybe experiencing it. ; ; At each acute episode, the participant is required to take a urine sample to be tested. They will then receive an automatic patient reported questionnaire (Urinary Tract Infection Symptom Assessment ‐ UTISA) via text to complete for the next 7 days. [From baseline to 6 months (24 weeks)] Severity of UTI symptoms via UTI symptom assessment (UTISA)[From baseline to 6 months (24 weeks)] INCLUSION CRITERIA: History of recurrent UTI or cystitis (self‐reported previous medical diagnosis) defined as at least two episodes of UTI and/or acute cystitis in the last 6 months and/or at least 3 episodes of UTI and/or acute cystitis in the last 12 months SECONDARY OUTCOME: 12 months incidence of UTIs/cystitis (participant self‐report) [Baseline and 12 months ] Burden of UTI via Recurrent UTI Impact Questionnaire (RUTIIQ)[From baseline to 12 months. Follow ups occurring monthly while on intervention ] Duration of UTI symptoms. This will be assessed by the patient‐reported outcome measure (UTISA) which will be automatically sent to the participant upon reporting and acute episode. The duration of the UTI will be measured by this questionnaire and recorded. [From baseline to 6 months. Follow ups occurring monthly while on intervention] Impairment via the Overactive Bladder questionnaire (OABq SF) [From baseline to 12 months. Follow ups occurring monthly while on intervention] Number of days of antibiotic use for cystitis and/or UTIs. This will be assessed by a phone call by the research assistant on day 7 after an acute episode. [From baseline to 6 months. Follow ups occurring monthly while on intervention ] Number of days of hospitalisation due to UTIs/cystitis. This will be assessed by a phone call by the research assistant on day 7 after an acute episode. [From baseline to 6 months. Follow ups occurring monthly while on intervention ] Quality of life via the SF‐36[From baseline to 12 months. Follow ups occurring monthly while on intervention ] Safety via adverse events via follow up visit questions on case report form. [From baseline to 6 months. Follow ups occurring monthly while on intervention ] Safety via kidney function via blood samples[From baseline to 6 months. Follow ups occurring monthly while on intervention.] Safety via liver enzymes via blood samples [From baseline to 6 months. Follow ups occurring monthly while on intervention.] Satisfaction via the Benefit, Satisfaction, Willingness (BSW)[From baseline to 12 months. Follow ups occurring monthly while on intervention ] The number of times they had to commence of prophylaxis medication via patient report at the follow up visit. [Baseline, 12 months ] Time to recurrence, i.e., time interval between UTI episodes. This will be assessed by the number of reported acute UTI episodes the patient reports which is recorded on REDCap and documented by the research assistant with the distance between episodes documented for analysis. [From baseline to 6 months. Follow ups occurring monthly while on intervention ]
Epistemonikos ID: 4c2d6d956d015b49793fdd0d2b7dd1ce890ad1ba
First added on: Aug 26, 2024