The primary objective of this study is to evaluate whether preventive intravesical instillations with 0.2% chondroitin sulphate solution reduce bother related to acute radiation cystitis symptoms patients undergoing pelvic radiotherapy.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Cost-efficiency of intravesical instillations with 0.2% chondroitin sulphate
solution to patients undergoing pelvic radiotherapy for cervical cancer
Background summary
About 20-25% of the female patients undergoing pelvic radiotherapy suffer from
symptoms related to acute radiation cystitis. These symptoms, involving
frequent micturition, urgency, nocturia, and urge-incontinence, are known to
negatively affect quality of life. Apart from that, treatment of these symptoms
carries considerable costs. Therefore we think it is important to try to
prevent this condition.
Study objective
The primary objective of this study is to evaluate whether preventive
intravesical instillations with 0.2% chondroitin sulphate solution reduce
bother related to acute radiation cystitis symptoms patients undergoing pelvic
radiotherapy.
Study design
Multi-centre double-blind randomised placebo controlled intervention study
Intervention
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 instilled with 0.2% chondroitin
sulphate solution and the control group with physiologic sodium chloride
solution.
Study burden and risks
Before randomisation patients fill in the questionnaire concerning micturition
symptoms and the effects on the quality of life. During the period of
radiotherapy patients will fill out a voiding diary (exept the days that they
might get chemotherapy).
Participating women will visit the (outpatient) gynaecology clinic weekly to
get the intravesical instillation. In week 4 and 12 after randomisation they
fill in the questionnaire.
The benefit of participating is that symptoms of radiation cystitis might be
prevented.
A pilotstudy showed that the instillations were well tolerated. No severe
adverse effects were reported.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35108.018.11 |