The goal of the study is to find out whether micturition complaints are prevented or reducted by the bladder instillations with Uracyst and secondly if it has a positive effect on painscores and micturition related quality of life.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are micturition frequency and bladdervolume
Secondary outcome
secondary outcomes are the burden of instillation, painscores and micturition
related quality of life
Background summary
Women with a gynaecologic malignancy, who are treated with external and
internal radiotherapy can suffer from side-effects of the treatment. All
patients will have complaints of acute radiation cystitis and around 25% more
severely. This is in most cases a self-limiting condition, and apart from
painkilling there is no treatment.
Whether quality of life is diminished by these symptoms in this group of
patients undergoing a heavy treatment-regimen is unknown. In literature however
there is evidence that over-active bladder complaints have a negative influence
on the quality of life.
For reduction of symptoms in interstitial cystitis intravesical chondroitin
sulphate solution has been effective. In this condition the glucosaminoglycan
(GAG) layer in the bladder has been damaged. This makes the urothelium more
permeable, which causes overstimulation of the afferent innervation of the
bladder and following that symptoms of cystitis occur. This etiology seems also
probable in acute radiation cystitis, where the urothelium, which produces the
GAG-layer, is damaged by the radiotherapy.
Study objective
The goal of the study is to find out whether micturition complaints are
prevented or reducted by the bladder instillations with Uracyst and secondly if
it has a positive effect on painscores and micturition related quality of life.
Study design
an open-label pilot study
Intervention
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 life-characteristics and burden
of treatment are filled in before the start of the radiotherapy and during 8
weeks after that. The treatment takes 5 to 7 weeks of radiotherapy in total.
Ten patients who refuse to undergo the instillation, but agree to fill in the
questionnaires, complete them at the same moments during the treatment.
Study burden and risks
extra visit on the gynaecologic department: only applicable for patients not
receiving chemotherapy: 12 hours in total
catheterisation: patient dependent: low to moderate burden; low risk of urinary
tract infection
postpone micturition during instillation: low to moderate burden
allergic reaction: very low risk
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2007-002622-30-NL |
| CCMO | NL17735.018.07 |