Uroial Plus in the Management of Infections and Urinary Symptoms Associated With Ureteral Stents

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called UroialTM Plus to see if it can help manage infections and urinary symptoms in patients with ureteral stents. Ureteral stents are small tubes placed in the urinary system to help with urine flow, but they can sometimes cause discomfort or lead to infections. In this study, participants will be divided into two groups: one will receive UroialTM Plus once a day for 30 days, and the other will receive a placebo (a dummy treatment that looks the same but has no active ingredients) for the same duration. Researchers will monitor symptoms and their impact on quality of life using questionnaires during the trial.

To participate, individuals must be over 18, have a ureteral stent placed after treatment for kidney stones or surgery, and be able to give consent. However, those with recent urinary infections, certain medical histories, or other specific conditions may not qualify. This trial is not yet recruiting participants, so those interested should keep an eye out for updates. Overall, this study aims to find out if UroialTM Plus can improve the experience of patients with ureteral stents.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age \> 18 years
• • patients with ureteral stents after endourological treatment for stone disease or abdominal surgery
• • ability to sign informed consent
• Exclusion Criteria:
• • positive urine culture 1 month before enrolment
• • recurrent urinary tract infections (3 episodes in the last 12 months, or 2 episodes in the last 6 months)
• • previous pelvic radiotherapy
• • history of transitional cell carcinoma (TCC)
• • history of painful bladder syndrome, actinic cystitis, chronic pelvic pain
• • symptomatic benign prostatic hypertrophy under treatment (for males)
• • presence of indwelling bladder catheter, suprapubic cystostomy, percutaneous nephrostomy, percutaneous cystostomy, urinary diversion
• • pregnancy or lactation
• • life expectancy \< 1 year
• • patients unable to give or refusing to sign informed consent
• • inability to follow protocol procedures
• • any condition that the investigator believes may be hazardous to the health of the Patient