Condition category
Urological and Genital Diseases
Date applied
03/11/2009
Date assigned
03/03/2010
Last edited
02/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rocco Damiano

ORCID ID

Contact details

Unità Operativa e Scuola Specializzazione in Urologia
Università Magna Graecia di Catanzaro
Campus di Germaneto
viale Europa
Catanzaro
88100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UROLUMG11/09

Study information

Scientific title

Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin: an interventional prospective randomised placebo-controlled trial

Acronym

Study hypothesis

Study drug induces a 70% decrease in the rate of urinary tract infections (UTIs) per patient/year in this study population.

Ethics approval

Institutional Review Board (IRB) of Magna Graecia University, Italy, approved on the 17th September 2009 (ref: CE/441/09)

Study design

Interventional prospective randomised double-blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urinary tract infections (UTIs)

Intervention

Patients will be randomised to receive:
1. Intravesical instillations of sodium HA (high molecular weight) 1.6% and CS 2.0% dose 50 ml of saline
2. Intravesical instillations of 50 ml saline (controls)

Both groups will be given therapy once weekly for 4 weeks and then once week or monthly for 5 months. Total follow-up: 12 months.

Intervention type

Drug

Phase

Phase II

Drug names

Hyaluronic acid, chondroitin

Primary outcome measures

Rate of UTIs per patient per year. Outcome assessment at 1, 3, 6, 9 and 12 months.

Secondary outcome measures

Outcome assessment at 1, 3, 6, 9 and 12 months:
1. Time to UTI recurrence
2. Rate of adverse events

Overall trial start date

01/12/2009

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 18 - 80 years old
2. Spontaneous urination
3. Greater than three uncomplicated UTIs/previous year
4. Free from UTIs at the beginning of study
5. No ongoing prophylactic antibiotic treatment
6. Able to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Greater than 50 ml residual urine
2. Neurological bladder disease
3. Known neoplasia, urinary stone or urinary tract abnormality
4. Use of indwelling catheter
5. Renal insufficiency
6. Diabetes
7. Current corticosteroid use
8. Pregnancy
9. Immunosuppressive disease

Recruitment start date

01/12/2009

Recruitment end date

31/05/2010

Locations

Countries of recruitment

Italy

Trial participating centre

Unità Operativa e Scuola Specializzazione in Urologia
Catanzaro
88100
Italy

Sponsor information

Organisation

Magna Graecia University (Italy)

Sponsor details

Department of Urology
Policlinico Mater Domini
Germaneto
Viale Europa
Catanzaro
88100
Italy

Sponsor type

University/education

Website

http://www.unicz.it/urologia

Funders

Funder type

University/education

Funder name

Magna Graecia University (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21272992

Publication citations

  1. Results

    Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R, Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial., Eur. Urol., 2011, 59, 4, 645-651, doi: 10.1016/j.eururo.2010.12.039.

Additional files

Editorial Notes