Administration of Mirabegron 50mg in patients with neurogenic bladder

Phase 1

Conditions: Spinal cord injuryMultiple sclerosis
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-002592-29-CZ

Lead Sponsor: Fakultní nemocnice Ostrava

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 92

Inclusion Criteria

Patients with the proved neurogenic detrusor overactivity NDO with complete or incomplete spinal cord injury or multiple sclerosis
Symptoms of NDO stable of at least 6 month
Patient able and willing to take the study medication according to the protocol
Patient able and willing to attend all examinations according to the protocol

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 92
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with the NDO of other origin than studied
Patients with symptomatic infection of urinary tract
Patients with interstitial cystitis, stones
Patients with bladder cancer or after radiation therapy in pelvis
Patients with severe renal or hepatic impairement
Patients with severe or nontreated hypertension

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Change of maximal cystometric capacity;Timepoint(s) of evaluation of this end point: V3 visit compaired to the baseline investigation;Main Objective: Exploration of the mirabegron 50mg efficacy compaired to placebo in patients with NDO;Secondary Objective: To assess the safety of the mirabegron 50mg compairing with the placebo in patients with NDO<br>To assess the mirabegron 50mg effect against placebo on the quality of the life<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in the volume of the nonvoiding contraction<br>Change of the maximal detrusor pressure<br>Change of the detrusor compliance<br>Change in the 24hours pad-weight test<br>Change in the i-QOL score<br>Change in the PPBC score<br>Change in the VAS TS score<br>;Timepoint(s) of evaluation of this end point: V3 visit compaired to the baseline investigation