Oral Supplementation With Uroial Plus in the Management of Infections and Urinary Symptoms Associated With Ureteral Stents.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 78
- Primary Endpoint
- Improvement rate
Study Overview
Brief 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.
Detailed Description
Study design The study is a pilot, interventional, double-blind, randomised clinical trial for two parallel groups with an intervention allocation ratio of 1:1. In this way it will be possible to evaluate the role of UroialTM Plus in rebalancing homeostasis in patients with ureteral stents, compared to a group of subjects, also with ureteral stents, who will be given a placebo. Data will be collected by filling in specific questionnaires by patients. The evaluation of the results of the questionnaires will be carried out in blind by an external operator.
Duration The study will last 16 months including a 12-month enrolment period. The study will start after the ethics committee has given a favourable opinion.
Setting The study will be conducted at the U.O.C of the Urological Clinic of the Policlinic "A. Gemelli" in Rome.
METHODS Population Seventy-eight patients undergoing ureteral stent placement after endourological treatment for calculosis or abdominal surgery will be consecutively enrolled at the Urology Clinic of the same hospital.
Patients will be assessed at the time of recruitment and subsequently re-evaluated at 7 and 30 days after enrolment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Improvement rate
Time Frame: 30 days after recruitment
Improvement rate will be the main endpoint of the study, and is defined as improvement of symptoms related to the presence of the ureteral stent with evidence to the answers of the questionnaires
Secondary Outcomes
- Complications(30 days after recruitment)
- Recruitment feasibility(30 days after recruitment)
- Impact on employment(30 days after recruitment)
Investigators
Foschi Nazario
Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS