Recurrent Urinary Tract InfectionsRAISC-RUTINCT02016118
Retrospective Analysis of Ialuril vs. Standard of Care in Recurrent Urinary Tract Infections
An observational study of Recurrent Urinary Tract Infections, run by Study Group for Urogenital Diseases, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Urinary Tract Infections
- What is being tested?
- Ialuril
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study will consider women with recurrent urinary tract infections who started their treatments at the Urology Departments at the enrolling centres.
Who may be able to join
- 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.
Who cannot join
- Women with complicated urinary tract infections. Complicated urinary tract infection occurs in individuals with functional or structural abnormalities of the genitourinary tract.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale S. Maria della Misericordia
Perugia, Perugia, 06156
Massimo Lazzeri, PhD, +393391072211, lazzeri.maximus@gmail.com
Elisabetta Costantini, MD
About this study
Official title: INTRAVESICAL ADMINISTRATION OF COMBINED HYALURONIC ACID (HA) AND CHONDROITIN SULPHATE (CS) vs. STANDARD OF CARE FOR THE TREATMENT OF RECURRENT URINARY TRACT INFECTIONS (RUTIs)
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).
Read the detailed description
RUTI is 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 colony forming units (CFU)/ml of an identified pathogen in the last year (M. Grabe, T.E. Bjerklund-Johansen, H. Botto, B. Wullt, M. Çek, K.G. Naber, R.S. Pickard, P. Tenke, F. Wagenlehner. Guidelines on Urological Infections. European Association of Urology 2012).
In order to do so, we will perform a retrospective analysis on prospectively collected patient data in nine European centres.
The treatment schedule for the intravesical administration of combined hyaluronic acid (HA) 1.6% and chondroitin sulphate (CS) 2.0% is one instillation 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.
The current standard management of RUTI in Europe is represented by the 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.
We will collect patient characteristics as age, BMI, sexual activity, employment status, severity of the disease, comorbidities.
Our primary clinical outcome will be the occurrence of objective (bacteriologically confirmed) recurrence within 12 months after the start of the treatment. Other outcomes will be the occurrence of clinical or symptoms based recurrence; the time to objective or symptoms based recurrence, evaluated from the start of the treatment until the first occurrence of an objective or symptoms based urinary tract infection, and the overall number of objective or symptoms based urinary tract infections experienced within 12 months after treatment initiation for RUTI.
Information about health related quality of life at baseline and 12 months will be recorded if available.
In terms of resource utilization, we will record the number of medical visits, number and types of laboratory, imaging and instrumental exams, hospitalization, consumption of pharmaceuticals or instrumental therapies (other than intervention and comparator) used within 12 months since treatment initiation. Number of days absent from work due to RUTI will be recorded when available. Costs will be attributed according to the perspective of the National Healthcare System searching for relevant data sources in each country.
Standard descriptive statistics, such as mean, median, range, and proportions, will be used to summarize patient characteristics and other collected variables. The Chi-Square test will be used to compare differences in proportions and the Mann-Whitney U test to compare continuous variables, with or without logarithmic transformation. The Kaplan-Meier method will be used to estimate time to recurrence outcomes.
- Conditions
- Recurrent Urinary Tract Infections
- Being tested
- Ialuril
- Keywords
- RUTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IalurilDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Urinary tract infection recurrence
At least one bacteriologically confirmed urinary tract infection experienced within 12 months after the treatment initiation.
Measured: within 12 months after treatment initiation
Secondary outcomes (1)
Occurrence of symptomatic urinary tract infection recurrence
At least one symptoms based urinary tract infection experienced within 12 months after the treatment initiation.
Measured: within 12 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Study Group for Urogenital Diseases, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Lazzeri, Study Group for Urogenital Diseases, Italy
- Investigators
- Massimo Lazzeri, PhD, Principal investigator, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016118
- Sponsor's protocol ID
- RAISC-RUTI
- Acronym
- RAISC-RUTI
- Status last verified
- Feb 2014
- First submitted
- 7 Oct 2013
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11752870Ciani 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.
PubMed 27033958
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRAVESICAL ADMINISTRATION OF COMBINED HYALURONIC ACID (HA) AND CHONDROITIN SULPHATE (CS) vs. STANDARD OF CARE FOR THE TREATMENT OF RECURRENT URINARY TRACT INFECTIONS (RUTIs)
- ClinicalTrials.gov ID
- NCT02016118
- Acronym / sponsor ID
- RAISC-RUTI / RAISC-RUTI
- Conditions
- Recurrent Urinary Tract Infections
- Keywords
- RUTI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Study Group for Urogenital Diseases, ItalyUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
RUTI is 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 colony forming units (CFU)/ml of an identified pathogen in the last year (M. Grabe, T.E. Bjerklund-Johansen, H. Botto, B. Wullt, M. Çek, K.G. Naber, R.S. Pickard, P. Tenke, F. Wagenlehner. Guidelines on Urological Infections. European Association of Urology 2012).
In order to do so, we will perform a retrospective analysis on prospectively collected patient data in nine European centres.
The treatment schedule for the intravesical administration of combined hyaluronic acid (HA) 1.6% and chondroitin sulphate (CS) 2.0% is one instillation 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.
The current standard management of RUTI in Europe is represented by the 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.
We will collect patient characteristics as age, BMI, sexual activity, employment status, severity of the disease, comorbidities.
Our primary clinical outcome will be the occurrence of objective (bacteriologically confirmed) recurrence within 12 months after the start of the treatment. Other outcomes will be the occurrence of clinical or symptoms based recurrence; the time to objective or symptoms based recurrence, evaluated from the start of the treatment until the first occurrence of an objective or symptoms based urinary tract infection, and the overall number of objective or symptoms based urinary tract infections experienced within 12 months after treatment initiation for RUTI.
Information about health related quality of life at baseline and 12 months will be recorded if available.
In terms of resource utilization, we will record the number of medical visits, number and types of laboratory, imaging and instrumental exams, hospitalization, consumption of pharmaceuticals or instrumental therapies (other than intervention and comparator) used within 12 months since treatment initiation. Number of days absent from work due to RUTI will be recorded when available. Costs will be attributed according to the perspective of the National Healthcare System searching for relevant data sources in each country.
Standard descriptive statistics, such as mean, median, range, and proportions, will be used to summarize patient characteristics and other collected variables. The Chi-Square test will be used to compare differences in proportions and the Mann-Whitney U test to compare continuous variables, with or without logarithmic transformation. The Kaplan-Meier method will be used to estimate time to recurrence outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ialuril | – | Device: IalurilIntravesical 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will consider women with recurrent urinary tract infections who started their treatments at the Urology Departments at the enrolling centres.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Women with complicated urinary tract infections. Complicated urinary tract infection occurs in individuals with functional or structural abnormalities of the genitourinary tract.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IalurilThe 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. | Device | Ialuril |
Primary outcome
Occurrence of Urinary tract infection recurrence
Time frame: within 12 months after treatment initiation
At least one bacteriologically confirmed urinary tract infection experienced within 12 months after the treatment initiation.
1 secondary outcome
Occurrence of symptomatic urinary tract infection recurrence
Time frame: within 12 months after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Background: PubMed 11752870Naber 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.
- Derived from this study: PubMed 27033958Ciani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Lazzeri, PhD principal investigator
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Urinary Tract Infections, run by Study Group for Urogenital Diseases, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Lazzeri, PhD (+393391072211, lazzeri.maximus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Urinary tract infection recurrence (time frame: within 12 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016118, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.