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van CCT (UK)

van CCT (UK)

Does the alpha blocker Silodosin improve the bladder emptying in patients with MS?

- candidate number23751
- NTR NumberNTR5666
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2016
- Secondary IDsNL54539.078.15 OZBS62.14078
- Public TitleDoes the alpha blocker Silodosin improve the bladder emptying in patients with MS?
- Scientific TitleAre alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis?
- ACRONYMAlpha blockers and MS
- hypothesisThe hypothesis is that the "uro-selective" alpha blocker Silodosin improves bladder emptying in women with MS
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS), Urinary retention, Alpha1-blockers
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-feb-2016
- planned closingdate
- Target number of participants30
- InterventionsThe 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.
- Primary outcome- Residual urine
- Secondary outcome- Quality of life (questionnaire: SF-Qualiveen)
- Symptom scores of voiding complaints (questionnaires: UDI-6 and IIQ-7)
- TimepointsAt t=0 and t=6 weeks.
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD candidate Sarah H.M. Reuvers
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Stichting Coolsingel
- Publications-
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD4-feb-2016 - 20-mrt-2016

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