Prevention of Acute Radiation cystitis by using Intra-vesical chondroitin Sulphate.

Prevention of Acute Radiation cystitis by using Intra-vesical chondroitin Sulphate. - PARIS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36593

Enrollment

140

Registered

2011-06-14

Start date

2011-04-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

irradiationlesion of the bladder

Interventions

Weekly intravesical instillations with 0.2% chondroitin sulphate solution or physiologic sodium chloride solution during the time of radiotherapy (mostly six weeks). The intervention group will be i

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Women undergoing primary or adjuvant pelvic radiotherapy for cervical cancer - Aged 18 years or older - Able to complete a Dutch questionnaire - Written informed consent

Exclusion criteria

Exclusion criteria: - Previous surgery of the lower urinary tract - (Supra-pubic) catheter in situ - Intermittent catheterisation because of bladder retention - Intravesical treatment * 6 months prior to inclusion - Urinary tract infection * 60 days prior to inclusion

Design outcomes

Primary

Measure	Time frame
The difference in Overactive Bladder domain score of the Urogenital Distress Inventory (UDI), as measured 12 weeks after the patient received the first instillation, between the intervention and control group	—

Secondary

Measure	Time frame
Cost-efficiency of intravesical instillations with 0.2% chondroitin sulphate solution to patients undergoing pelvic radiotherapy for cervical cancer	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)