Improves the alpha blocker Silodosin the bladder emptying in patients with MS? Improves the alpha blocker Silodosin the quality of life of patients with MS?
ID
Source
Brief title
Condition
- Demyelinating disorders
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Residual urine, measured within 10 minutes after a voluntary void at t=0 and
t=6 weeks.
Secondary outcome
- Quality of life (questionnaire: Qualiveen) at t=0 and t=6 weeks.
- Symptom scores of voiding complaints (questionnaires: UDI-6 and IIQ-7) at t=0
and t=6 weeks.
Background summary
On theoretical grounds, on the basis of clinical and pre-clinical studies, and
on personal experience it can be expected that "uro-selective" alpha blockers
greatly improve bladder emptying in MS patients. This results in a decrease of
the need for CISC/indwelling catheter with a consecutive decrease of UTI's and
incontinence episodes. The overall outcome is an improvement of the quality of
life of patients with MS.
Study objective
Improves the alpha blocker Silodosin the bladder emptying in patients with MS?
Improves the alpha blocker Silodosin the quality of life of patients with MS?
Study design
This study is a prospective, placebo-controlled, double-blind, randomized
study.
Intervention
One group receives the alpha blocker Silodosin during 6 weeks while the second
group is treated with placebo during the same period.
Study burden and risks
The burden and risks associated with the participation are minimal. The
subjects are asked to complete three short questionnaires two times during a 6
week period and two times residual urine measurements will be done. After 3
weeks an evaluation of side-effects will be performed by telephone.
Furthermore, the number of study visits is two, this is no extra visit compared
to standard treatment.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Female
- Age >= 18 years
- Any form of MS
- Residual urine 60 ml - 250 ml
- Adequate understanding of the Dutch language
Exclusion criteria
- Dependency of wheel chair
- Being bedridden
- Indwelling catheter
- Clean intermittent catheterization
- Acute attack of MS
- Current treatment with an alpha-blocker
- Pregnancy/breastfeeding
- Severe kidney dysfunction
- Orthostatic hypotension
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-002820-20-NL |
| CCMO | NL54539.078.15 |
| OMON | NL-OMON26059 |