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

• Register: EUCTR
• Last refreshed on: 9 November 2020
• Main ID: EUCTR2015-002820-20-NL
• Date of registration: 21/01/2016
• Prospective Registration: Yes
• Primary sponsor: Erasmus MC Dept. Urology
• Public title: Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis?
• Scientific title: Are alpha blockers effective in the treatment of bladder elimination problems in female patients with Multiple Sclerosis? - Alpha blockers and Multiple Sclerosis (MS)
• Date of first enrolment: 03/02/2016
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002820-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: Principal Investigator
• Affiliation: Erasmus MC

• Name: Principal Investigator
• Affiliation: Erasmus MC

Key inclusion & exclusion 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:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

NL54539.078.15

OZBS62.14078

Source(s) of Monetary Support

Stichting Coolsingel

Ethics review

Status: Approved
Approval date: 03/02/2016
Contact: