Cervical cancer, endometrial cancer, pelvic radiotherapy, cystitis, quality of life, chondroitin sulphate Cervix carcinoom, endometrium carcinoom, bekkenbestraling, cystitis, kwaliteit van leven, chondroitine sulfaat
Conditions
Interventions
Once weekly profylactic instillation with chondroitin sulphate solution or placebo (sodium chloride solution) during the period of pelvic radiotherapy.
Sponsors
Academic Medical Centre (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Indicated to undergo primary or adjuvant pelvic radiotherapy for gynaecologic malignancy; 2. Aged 18 years or older; 3. Able to complete a Dutch questionnaire; 4. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous surgery of the lower urinary tract; 2. (Supra-pubic) catheter in situ; 3. Intermittent catheterisation because of bladder retention; 4. Intravesical treatment ≤ 6 months prior to inclusion; 5. Urinary tract infection (positive culture) ≤ 60 days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| 1. Voiding frequency in daytime and night time as assessed by a voiding diary; 2. Maximum bladder capacity as assessed by a voiding diary; 3. Pain domain, obstructive micturition domain, and incontinence domain of the UDI; 4. Generic quality of life as assessed by the SF36 Health Survey; 5. Cost-effectiveness; 6. Cost-utility (see economic evaluation); 7. Number of adverse events. | — |
Contacts
Public ContactJan-Paul W.R. Roovers
PO Box 22660
Outcome results
None listed