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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37534393
Enrollment
30
Registered
2013-03-20
Start date
2010-05-01
Completion date
Unknown
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late radiation tissue cystitis with or without haematuria Urological and Genital Diseases Irradiation cystitis

Interventions

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 day

Sponsors

Institut Biochimique SA (IBSA) (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients with symptomatic LRTC after receiving primary or adjuvant radiotherapy for pelvic neoplasms

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The tolerability, safety and efficacy of the treatment at reducing the symptoms and signs of LRTC at 3 and 12 months

Secondary

MeasureTime frame
Quality of Life (QoL), measured at 3 and 12 months

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026