MedTrace Logo

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

NCT06251336 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-02-12

No results posted yet for this study

Summary

Double-blind randomised interventional pilot study. To evaluate whether therapy with UroialTM Plus has a role in rebalancing homeostasis in ureteral stent patients, improving symptoms related to the presence of the ureteral stent in place.

Ureteral stent patients will be randomised into two groups:

* the experimental group will receive UroialTM Plus sachets, one sachet daily at bedtime after urinating, for 30 days
* the control group will receive a placebo, one sachet daily in the evening before going to bed after urinating, for 30 days.

At each visit, the investigator will assess the possible occurrence of urinary symptoms, their severity and their impact on quality of life by administering the following questionnaires: IPSS, USSQ, AIA, SF-36, VAS, EQ-5D-5L.

Conditions

Interventions

OTHER

UroialTM Plus

Nutraceutical

OTHER

Placebo

Placebo sachet

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Nazario Foschi, MD · Università Cattolica del Sacro Cuore, Policlinico Universitario Agostino Gemelli

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-09-01
Completion
2025-01-01

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06251336 on ClinicalTrials.gov