Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis?

Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis? - Alpha blockers and Multiple Sclerosis (MS)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002820-20-NL

Enrollment

Registered

2016-01-21

Start date

2016-02-03

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder dysfunction in Multiple Sclerosis MedDRA version: 20.0 Level: PT Classification code 10069632 Term: Bladder dysfunction System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Silodyx Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Female - Age = 18 years - Any form of MS - Residual urine 60 ml - 250 ml - Adequate understanding of the Dutch language Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Main Objective: Improves the alpha blocker Silodosin the bladder emptying in patients with MS?;Secondary Objective: Improves the alpha blocker Silodosin the quality of life of patients with MS?;Primary end point(s): Residual urine, measured within 10 minutes after a voluntary void at t=0 and t=6 weeks.;Timepoint(s) of evaluation of this end point: t=0 and t=6 weeks.	—

Secondary

Measure	Time frame
Secondary end point(s): - 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.;Timepoint(s) of evaluation of this end point: t=0 and t=6 weeks.	—

Countries

Netherlands

Contacts

Public ContactPrincipal Investigator

Erasmus MC

j.scheepe@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026