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ISRCTN
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ISRCTN37534393
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DOI
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10.1186/ISRCTN37534393
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Intravesical hyaluronic acid (HA) and chondroitin sulphate (CS) for treatment of signs and symptoms of patients with late radiation tissue cystitis (LRTC): an investigative pilot study
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Scientific title
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Acronym
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N/A
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Serial number at source
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001/Magenta
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Study hypothesis
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To test the hypothesis that a combined solution containing high concentration of HA and CS may improve LRTC symptoms and signs.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Institutional Review Board (001/Magenta)
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Study design
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Prospective longitudinal non-randomized investigative pilot study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Late radiation tissue cystitis with or without haematuria
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Participants - inclusion criteria
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Eligible patients with symptomatic LRTC after receiving primary or adjuvant radiotherapy for pelvic neoplasms
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Participants - exclusion criteria
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1. Patients (male and female, age range: 40-80 years) undergoing chemotherapy
2. Those with a life expectancy of less than 24 months
3. Those with radiological confirmed metastasis
4. Patients receiving radiotherapy for bladder cancer
5. Patients with documented urethral strictures
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Anticipated start date
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01/05/2010
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Anticipated end date
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31/12/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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30
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Interventions
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Enrolled patients were treated with intravesical instillations of Ialuril®, a 50 ml/vial solution containing HA 800 mg and CS 1 mg. Patients with severe haematuria (daily) received instillations 5 days/week in the 1st month, 3 days/week in the 2nd month, 2 days/week in the 3rd month, once weekly in months 4-6, every two weeks in months 7-8, every three weeks in months 9-10, and monthly/bimonthly for one year.
Patients without or with occasional haematuria received instillations 3 days/week in the 1st month, 2 days/week in the 2nd
month, 1 day/week in months 3-4, every two weeks in months 5-6, every three weeks in months 7-8, and monthly/bimonthly for one year. The solution was retained in the bladder for 45-60 minutes in the 1st month, with rotation in four positions (supine, prone, left and right flank), and for ≥ 80 minutes thereafter.
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Primary outcome measure(s)
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To investigate the tolerability, safety and efficacy of the treatment in reducing the symptoms and signs of LRTC at 3 and 12 months
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Secondary outcome measure(s)
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To assess changes in quality of Life (QoL) resulting from the treatment, measured at 3 and 12 months
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Sources of funding
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Regional Health System (Italy)
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Trial website
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Publications
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Contact name
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Dr
Massimo
Lazzeri
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Address
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Department of Urology
San Raffaele Turro
Vita-Salute San Raffaele University
Via Stamira d’Ancona 20
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City/town
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Milan
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Zip/Postcode
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20127
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Country
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Italy
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Sponsor
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Institut Biochimique SA (IBSA) (Italy)
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Address
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Via Emilia
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City/town
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Lodi
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Zip/Postcode
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26900
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Country
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Italy
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Sponsor website:
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http://www.ibsa-international.com/
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Date applied
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05/03/2013
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Last edited
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20/03/2013
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Date ISRCTN assigned
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20/03/2013
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