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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2016
INTERVENTION: Trade Name: Silodyx Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: 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] PRIMARY OUTCOME: Main Objective: Improves the alpha blocker Silodosin the bladder emptying in patients with MS? Primary end point(s): Residual urine, measured within 10 minutes after a voluntary void at t=0 and t=6 weeks. Secondary Objective: Improves the alpha blocker Silodosin the quality of life of patients with MS? Timepoint(s) of evaluation of this end point: t=0 and t=6 weeks. SECONDARY OUTCOME: 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. 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
Epistemonikos ID: 13b0538f30345b06ac8c182421dc7130ac9f9361
First added on: Mar 31, 2022