Is Uracyst effective to prevent or reduce acute radiation cystitis in patients who are treated with radiotherapy for gynaecologic malignancy?

Is Uracyst effective to prevent or reduce acute radiation cystitis in patients who are treated with radiotherapy for gynaecologic malignancy? - Uracyst-RC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31418

Enrollment

Registered

2007-07-12

Start date

2007-06-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

acute radiation cystitis inflammatory disease of the bladder caused by radiotherapy

Interventions

It is our intention to perform bladder instillations, with intravesical chondroitin sulphate 0.2% solution, Uracyst®-s, in 10 patients. Questionnaires concerning micturition-, pain- and quality of l

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female * 18 years of age; Cervical cancer FIGO stage IIB-IIIB/ cervical cancer FIGO stage IB-IIA needing adjuvant (chemo-) radiotherapy/ endometrial cancer with (adjuvant) radiotherapy; Must provide a signed informed consent.

Exclusion criteria

Exclusion criteria: History of previous procedure(s) (e.g., augmentation cystoplasty, cystectomy or cystolysis), diseases or infections of the bladder or urethra that has affected bladder function; Urinary tract infection * 90 days prior to baseline; Participated in another clinical study with an investigational drug or device * 30 days prior to baseline.

Design outcomes

Primary

Measure	Time frame
The primary outcomes are micturition frequency and bladdervolume	—

Secondary

Measure	Time frame
secondary outcomes are the burden of instillation, painscores and micturition related quality of life	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)