Retrospective Analysis of Ialuril vs. Standard of Care in Recurrent Urinary Tract Infections

NCT02016118 | Unknown

• 1 other identifier: RAISC-RUTI
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness and costs associated with the intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS) compared to the current standard management of recurrent urinary tract infections in adult women diagnosed with recurrent urinary tract infections (RUTI).

Conditions

Recurrent Urinary Tract Infections

Keywords

RUTI

Outcome Measures

Primary Outcomes (1)

• Occurrence of Urinary tract infection recurrence

  At least one bacteriologically confirmed urinary tract infection experienced within 12 months after the treatment initiation.

  within 12 months after treatment initiation

Secondary Outcomes (1)

• Occurrence of symptomatic urinary tract infection recurrence

  within 12 months after treatment initiation

Other Outcomes (3)

• Mean direct overall costs

  within 12 months after treatment initiation

• Number of days absent from work

  within 12 months after treatment initiation

• Time-to-recurrence

  12 months after treatment initiation

Study Arms (2)

Ialuril

Intravesical administration of combined hyaluronic acid (HA) 1.6% and chondroitin sulphate (CS) 2.0% once per week for the first month, followed by one instillation every two weeks for the second month and one instillation per month until stable remission of the symptoms.

Device: Ialuril

Standard of care

Antimicrobial prophylaxis (continuous or postcoital), as described in the Guidelines on Urological Infections of the European Association of Urology or Immunoactive prophylaxis or Prophylaxis with probiotics or Prophylaxis with cranberry, or combination of these.

Interventions

Ialuril DEVICE

The treatment is an intravesical administration of combined hyaluronic acid (HA) 1.6% and chondroitin sulphate (CS) 2.0% once per week for the first month, followed by one instillation every two weeks for the second month and one instillation per month until stable remission of the symptoms.

Ialuril

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will consider women with recurrent urinary tract infections who started their treatments at the Urology Departments at the enrolling centres.

You may qualify if:

• Women aged 18-75 years old.
• Women diagnosed with recurrent urinary tract infections, defined as at least three episodes of uncomplicated urinary tract infections accompanied by clinical symptoms and documented by urine culture with the isolation of \>103 CFU/ml of an identified pathogen in the last year. Uncomplicated or 'simple' UTI is defined as an infection in a person with normal urinary tract and function.

You may not qualify if:

• \- Women with complicated urinary tract infections. Complicated urinary tract infection occurs in individuals with functional or structural abnormalities of the genitourinary tract.

Sponsors & Collaborators

• Study Group for Urogenital Diseases, Italy: lead

Study Sites (1)

Ospedale S. Maria della Misericordia

Perugia, Perugia, 06156, Italy

RECRUITING

Related Publications (2)

• Naber KG, Bergman B, Bishop MC, Bjerklund-Johansen TE, Botto H, Lobel B, Jinenez Cruz F, Selvaggi FP; Urinary Tract Infection (UTI) Working Group of the Health Care Office (HCO) of the European Association of Urology (EAU). EAU guidelines for the management of urinary and male genital tract infections. Urinary Tract Infection (UTI) Working Group of the Health Care Office (HCO) of the European Association of Urology (EAU). Eur Urol. 2001 Nov;40(5):576-88. doi: 10.1159/000049840.

  PMID: 11752870 BACKGROUND

• Ciani O, Arendsen E, Romancik M, Lunik R, Costantini E, Di Biase M, Morgia G, Fragala E, Roman T, Bernat M, Guazzoni G, Tarricone R, Lazzeri M. Intravesical administration of combined hyaluronic acid (HA) and chondroitin sulfate (CS) for the treatment of female recurrent urinary tract infections: a European multicentre nested case-control study. BMJ Open. 2016 Mar 31;6(3):e009669. doi: 10.1136/bmjopen-2015-009669.

  PMID: 27033958 DERIVED

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

• Massimo Lazzeri, PhD

  Università Vita-Salute San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Lazzeri, PhD

CONTACT

+393391072211; lazzeri.maximus@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Consultant

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

IT (1)