Detrusor hyperactivity caused by neurological dysfunction MedDRA version: 14.1 Level: PT Classification code 10061011 Term: Bladder disorder System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Oxybutynin 0.1% Grachtenhaus
Pharmaceutical Form: Solution for intravesical use
INN or Proposed INN: Oxybutynin hydrochloride
CAS Number: 1508-65-2
Concentration unit: % (W/W) percent we
Sponsors
Grachtenhaus-Apotheke, Inh. Klaus Stegemann e.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patient´s written informed consent - patients of both gender aged 18 to 70 years - patients, who are experienced in the performance of clean (or sterile) intermittent catheterization (CIC) and who perform regularly CIC for at least 6 weeks - patients with detrusor hyperactivity confirmed by urodynamic measurement within the last 24 months and associated with a known neurological deficit 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 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - patients under effective and compatible medication - diseases like polyuria or nycturia due to heart or renal failure, subvesical organic urinary output failure (e. g. prostataadenom, urethral stricture), constrictions (stenosis) in the area of the remaining urinary passage and gastrointestinal tract, acute angle-closure glaucoma (glaucoma) or complanate anterior chamber, fast and abnormal heartbeat (cardiac tachyarrhythmia), severe colon aneurysma (toxic megacolon), severe arteriosclerotic alteration of the celebral vessels (cerebrosclerosis), intestinal obstruction, hiatal hernia with reflux esophagitis, phlogistic colon ulcer, colon atresia - Myasthenia gravis - severe hydronephrosis greater than grade 3; a renal ultrasound performed within 3 months prior to entering the study will be accepted as a baseline measurement if this assessment was performed while the patient was on a stable medication regimen - severe vesical-renal reflux higher than grade 3 according to Parkkulainen based on urodynamic measurement for diagnosis - symptomatic (febrile) urinary tract infection - severe limitations in renal function according to laboratory chemical determination of renal function values (Kreatinin > 2,5 mg/dl) - pathological intraocular pressure – measured within 12 month prior to entering the study - clinically significant laboratory abnormalities (based on investigator judgment) or laboratory values greater than 2 times the upper limit of standard range - liver or renal insufficiency - intake of warfarin, ranitidine or cimetidine - intake of CYP3A4 inhibiting pharmaceuticals or substances like clomipramine, itraconazole, ketoconazole, testosterone, troleandomycin or CYP2D6 inhibiting pharmaceuticals like dextromethorphan - intake of anticholinergic or anticholinergic acting pharmaceuticals enhancing the function of oxybutynin, e. g. amantadin and other Anti-Parkinson’s pharmaceuticals, antihistamines, neuroleptics, chinidin, digitalis, trizyclic antidepressants, atropine and related compounds - intolerance to the active ingredient oxybutynin - medical history of allergy/hypersensitivity (including drug and sulfa drug allergy) which is deemed as relevant to the trial as judged by the investigator - treatment with Botulinum Toxin Type A (Botox) injections for urologic use within 6 months of randomization at screening visit - drug therapy, or non-drug therapy including electrostimulation for their neuropathic bladder initiated during the four weeks prior to screening or anticipated to initiate during the study - surgical procedure under general anaesthesia within 30 days prior to screening visit - participation in another trial with an investigational drug within 30 days prior to screening or during the trial - pregnant or lactating women; all female patients of child bearing potential, who are sexually active in the opinion of the investigator, have to use one accepted and highly effective agent of birth control with a Pearl Index = 1% - patients who cannot understand the terms of the informed consent form and/or subject information in the investigator's view - patients who are or have been committed to an institution by virtue of an order either by the judicial or the administrative authorities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the alteration of the maximal cystometric bladder capacity between visit 1 and visit 3 (urodynamic measurement);Secondary Objective: - alteration of the catheterized urine volume between the last 3 days before visit 1 and visit 3 (via patient´s diary) - alteration of the frequency of daily incontinences between the last 3 days before visit 1 and visit 3 (via patient´s diary) - alteration of the subjective assessment of quality of life and treatment satisfaction between the last 3 days before visit 1 and visit 3 (via IQoL) - alteration of urodynamic endpoints between visit 1 and 3 - a reduction of the number of daily catheterization between the last three days before visit 1 and visit 3 (via patient's diary) - local tolerability via registration of side effects, urine testing and questions concerning tolerability - local tolerability via cystocopy at end of 12-months follow-up study - safety (kind, frequency and severity of side effects, premature study discontinuation, physical examination, ECG, vital signs, laboratory blood and urine values) ;Primary end point(s): The primary endpoint is: • an alteration of the maximal cystometric bladder capacity between visit 1 and visit 3 (via urodynamic measurement);Timepoint(s) of evaluation of this end point: The primary endpoint is: • an alteration of the maximal cystometric bladder capacity between visit 1 and visit 3 (via urodynamic measurement) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • a change of the catherizated urine volume between the 3 untreated days before visit 1 and the last 3 days of treatment before visit 3 (via patient diary) • a change of the frequency of unvolentary loss of urine between the 3 untreated days before visit 1 and the last 3 days of treatment before visit 3 (via patient diary) • a change of the sujective evaluation of quality of life and satisfation with the treatment between the 3 untreated days before visit 1 and the last 3 days before visit 3 (via IQol questionaire) • a change of urodynamic end points (maximal pressure of detrusor during the filling phase, reflexvolume, detrusor compliance) between visit 1 and visit 3; additional will in patients with loss of urine the urodynamic end points "Leak Point Pressure" and bladder filling volume of loss of urine be recorded • a reduction of daily catheterization numbers between the last 3 days without treatment before visit 1 and the last 3 days of treatment before visit 3 (via patient diary) Tolerability: • local tolerability via registration of advers events, urine analysises, questions of tolerability • local tolerability via cystocopy at end of 12-months follow-up study Safety: • kind, frequency and severity of spontaneous reported adverse events • early stop of study medication because of adverse events • physical examination • ECG • laboratory values of blood and urine • vitalparameters ;Timepoint(s) of evaluation of this end point: Efficacy: • between 3 untreated days before v1 and last 3 days of treatment before v3 (via patient diary) • between 3 untreated days before v1 and last 3 days of treatment before v3 (via patient diary) • between 3 untreated days before v1 and last 3 days before v3 (via IQol questionaire) • between v1 and v3 • between 3 untreated days before v1 and last 3 days of treatment before v3 (via patient diary) Tolerability: • local tolerability via registration of advers events, uri | — |
Countries
Germany
Contacts
Public ContactCRO
Mediconomics GmbH
Outcome results
None listed