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

NCT06251336 | Not Yet Recruiting

• 1 other identifier: 6184
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ureteral Stent-Related Symptom; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Improvement rate

  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

  30 days after recruitment

Secondary Outcomes (3)

• Recruitment feasibility

  30 days after recruitment

• Complications

  30 days after recruitment

• Impact on employment

  30 days after recruitment

Study Arms (2)

Uroial Plus Arm

EXPERIMENTAL

UroialTM Plus sachets one sachet daily at night before going to bed after urinating for 30 days

Other: UroialTM Plus

Placebo Arm

PLACEBO COMPARATOR

one placebo sachet daily at night before going to bed after urinating for 30 days

Other: Placebo

Interventions

UroialTM Plus OTHER

Nutraceutical

Also known as: UroialTM Plus S&R Pharmaceutics S.p.A.

Uroial Plus Arm

Placebo OTHER

Placebo sachet

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• patients with ureteral stents after endourological treatment for stone disease or abdominal surgery
• ability to sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nazario Foschi, MD

  Università Cattolica del Sacro Cuore, Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazario Foschi, MD

CONTACT

+393491002858; nazario.foschi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 1:1

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: February 9, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share