No registrations found.
ID
Source
Brief title
Health condition
Multiple Sclerosis
MS
neurogene blaas
neurogenic bladder
residual urine
urine residu
bladder residual volume
blaasresidu
alpha blockers
alpha blokkers
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Residual urine
Secondary outcome
- Quality of life (questionnaire: SF-Qualiveen)
- Symptom scores of voiding complaints (questionnaires: UDI-6 and IIQ-7)
Background summary
This study is a prospective, placebo-controlled, double-blind, randomized study.
The objective of the study is to investigate if the alpha blocker Silodosin improves the bladder emptying and the quality of life in patients with MS.
30 female patients (18 years or older) with relapsing-remitting MS and bladder emptying dysfunction will be recruited and divided into 2 groups of 15 patients. One group receives Silodosine for 6 weeks and one group receives placebo. Residual urine and quality of life and symptom score questionnaires will be measured at t = 0 en t = 6 weeks.
Study objective
The hypothesis is that the "uro-selective" alpha blocker Silodosin improves bladder emptying in women with MS
Study design
At t=0 and t=6 weeks.
Intervention
The investigational product is Silodosin, a "uro-selective" alpha blockers. The dosage is 8 mg once daily per os. One group receives Silodosin for 6 weeks while the second group is treated with a placebo during the same period.
Sarah H.M. Reuvers
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
Tel: +31 (0) 10 – 703 10 39
s.reuvers@erasmusmc.nl
Sarah H.M. Reuvers
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
Tel: +31 (0) 10 – 703 10 39
s.reuvers@erasmusmc.nl
Inclusion criteria
- Female
- Age 18 years or older
- Relapsing-remitting MS
- Residual urine 80 ml ¡§C 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
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5545 |
| NTR-old | NTR5666 |
| CCMO | NL54539.078.15 |
| OMON | NL-OMON47090 |