Prevention of Acute Radiation cystitis by using Intra-vesical chondroitin Sulphate.
Completed
- Conditions
- Cervical cancer, endometrial cancer, pelvic radiotherapy, cystitis, quality of life, chondroitin sulphateCervix carcinoom, endometrium carcinoom, bekkenbestraling, cystitis, kwaliteit van leven, chondroitine sulfaat
- Registration Number
- NL-OMON28986
- Lead Sponsor
- Academic Medical Centre (AMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
1. Indicated to undergo primary or adjuvant pelvic radiotherapy for gynaecologic malignancy;
2. Aged 18 years or older;
Exclusion Criteria
1. Previous surgery of the lower urinary tract;
2. (Supra-pubic) catheter in situ;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Voiding frequency in daytime and night time as assessed by a voiding diary;<br /><br>2. Maximum bladder capacity as assessed by a voiding diary;<br /><br>3. Pain domain, obstructive micturition domain, and incontinence domain of the UDI;<br /><br>4. Generic quality of life as assessed by the SF36 Health Survey;<br /><br>5. Cost-effectiveness;<br /><br>6. Cost-utility (see economic evaluation);<br /><br>7. Number of adverse events.