neurogenic detrusor overactivity MedDRA version: 16.0 Level: LLT Classification code 10012547 Term: Detrusor hyperreflexia System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Mictonorm Uno
Pharmaceutical Form: Modified-release capsule, hard
Other descriptive name: PROPIVERINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
APOGEPHA Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with stable neurogenic detrusor overactivity (NDO) due to spinal cord injuries. 2.Ability to understand the patient information and presence of a personally signed and dated informed consent to participate in the study before completing any study related procedures. 3.Female and male patients aged 18 years or older at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. 4.Primarily proven NDO with evidence of reflex detrusor contractions in previous pressure-flow-studies. 5.Ability to practice clean intermittent catheterization (by the patient himself or a nurse/relative) at least 4 to 6 times daily. 6.The patient is co-operative and without time-limit available for the entire study duration. 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1.Acute urinary tract infection (= 105 bacteria/ml urine) as defined by the investigator. 2.Multiple sclerosis and other systemic neurological disease under unstable conditions leading to voiding and/or bladder storage problems. 3.Botulinum toxin injections into the bladder within the last 12 month. 4.Bladder surgery (e.g. augmentation cystoplasty) or stomata for catheterization (e.g. Mitrofanoff, Mainz pouch). 5.Sacral nerve stimulation (neuromodulation) or electrostimulation therapy within the last 4 weeks before randomization into the study. 6.Presence of bladder or ureteral stones. 7.Surgeries of the lower genitourinary tract within the last 6 months before randomization (e.g. prostatectomy, hysterectomy, tumor surgery) that endanger the integrity of the study in the opinion of the investigator. 8.Medical history of previous radiotherapy of the bladder, prostate, or pelvis. 9.Medical history of cancer of the bladder, prostate, or pelvis that endanger the integrity of the study in the opinion of the investigator. 10.Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis) that endanger the integrity of the study in the opinion of the investigator. 11.Medical history of cardiac insufficiency (NYHA stage IV). 12.Evidence of severe renal, hepatic or metabolic disorders that endanger the integrity of the study in the opinion of the investigator and/or that are confirmed by clinical significant laboratory results. 13.Medical history of pre-existing medical contraindications for antimuscarinics (e.g. obstruction of the bowel, Barrett syndrome, toxic megacolon, severe colitis ulcerosa, bladder or intestinal atony, significant degree of bladder outflow obstruction where urinary retention may be anticipated, pollakiuria of cardiac or renal genesis, tachyarrhythmia, angle-closure glaucoma, myasthenia gravis). 14.Known hypersensitivity to propiverine hydrochloride or excipients contained in the trial medication (e.g. lactose monohydrate, coloring agent cochineal red), respectively. 15.Concomitant medication known to have a potential to interfere with the trial medication or the goals of the trial (see section 8.4.6). 16.Pregnant or breast-feeding women or women of childbearing potential without using any reliable contraceptive methods. 17.Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study. 18.Current or history of impaired renal function as indicated by clinically significantly abnormal creatinine or urea values and abnormal creatinine clearance calculated with the Larsson formula. 19.Participation in another clinical trial with an investigational medicinal product within the last month prior to randomization. 20.An inability to swallow all investigational medicinal products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy of propiverine hydrochloride ER 45 mg s.i.d. versus propiverine hydrochloride IR 15 mg t.i.d. in patients with NDO in terms of percent change of bladder volume at first detrusor contraction in relation to the baseline value measured after the run-in phase.;Primary end point(s): Relative change of bladder volume at first detrusor contraction (reflex volume) in relation to the baseline values determined by standardized cystometric measurements after the run-in phase;Timepoint(s) of evaluation of this end point: Day 35;Secondary Objective: The secondary objectives are to compare the efficacy of the study medication (Test vs. Reference) assessed by additional cystometric and clinical parameters and to assess the tolerability of propiverine hydrochloride ER 45 mg s.i.d. vs. propiverine hydrochloride IR 15 mg t.i.d. in patients with NDO. The secondary variables will also be reported in terms of relative change from baseline, if applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Maximum detrusor pressure, maximum cystometric capacity, bladder compliance, detrusor pressure at the time of the first detrusor contraction, occurrence of leakage, leak point volume and leak point pressure as determined by standardized cystometric measurement - Intake and voiding diary: number of voidings and/or clean intermittent catheterizations (CIC), voided and catheterized volume, incontinence episodes, number and size of pads used, fluid intake - Quality of Life (QoL) The secondary variables will be reported in terms of percent change from baseline as well, if applicable. ;Timepoint(s) of evaluation of this end point: Day 35 | — |
Countries
Germany
Contacts
Public ContactCornelia Feustel
APOGEPHA Arzneimittel GmbH
Outcome results
None listed