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

Phase 1

• Conditions: Bladder dysfunction in Multiple Sclerosis; MedDRA version: 20.0Level: PTClassification code 10069632Term: Bladder dysfunctionSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-002820-20-NL
• Lead Sponsor: Erasmus MC Dept. Urology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-21
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Secondary end point(s): - Quality of life (questionnaire: Qualiveen) at t=0 and t=6 weeks.<br>- 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.