•Male or female (18 – 80 years) suffering from OAB. •Symptoms of OAB as defined by: Urgency frequency =7 /week,•Urinary urgency incontinence (= 7 UIE/week),•Urodynamically proven detrusor instability MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Trade Name: Oxybutynin-ratiopharm 5 mg Tabletten
Product Name: Oxybutynin-ratiopharm 5mg
Product Code: 39432.00.00
Pharmaceutical Form: Tablet
INN or Proposed INN: Oxybutyninhydrochlorid
CAS Number: 1
Sponsors
Johannes Gutenberg-Universität Mainz, Urologische Klinik (ausführende Stelle), Prof. Dr. med. Thürof
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female (18 – 80 years) suffering from OAB. •Symptoms of OAB as defined by: •Urgency frequency =7 /week •Urinary urgency incontinence (= 7 UIE/week) •Urodynamically proven detrusor instability •Women must be surgically sterile or •Women must be postmenopausal (postmenopausal means a period after menopause, thus the time of the last menstruation, which follows retrospectively two years long no further ovariell controlled uterine bleeding) or •Women mus be older than 55 years and received in the last 5 months no hormone substitution therapy or •Women must agree to use effective contraception during treatment phases (i.e. contraceptions with a failure ratio of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following criteria as according to their history will not be included in the trial: •Pregnancy and lactation. •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. •Subjects with uncontrolled arterial hypertension (systolic blood pressure > 160 mmHg and diastolic blood pressure > 100 mmHg) •Subjects with clinically relevant arrhythmic changes in ECG (e.g. AV-block grade II or III, QT-prolongations, Long QT syndrome) •Subjects with factors of risk for Torsade de Pointes •Subjects with cardiac insufficiency (NYHA II – NYHA IV) •Subjects with hypokalaemia •Subjects with drugs which have prolongation potential •Subjects with coronary heart disease (CHD) •Subjects with hyperthyroidism •Subjects being treated with CYP3A4-inhibitors like azole antifungals (e.g. ketoconasole) or macrolid antibiotics (e.g. erythromycin). •Subjects with uncontrolled narrow-angle glaucoma. •Subjects with myasthenia gravis. •Subjects with significant urinary obstruction as measured during cystometry (e.g. prostatic hyperplasia, stricture of urethra). •Subjects with significant obstructions in the area of the residual urinary tract and the gastrointestinal tract. •Subjects with intestinal atony or bowel obstruction. •Subjects with severe gastro-intestinal condition (e.g. severe ulcerative colitis or toxic megacolon). •Subjects with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption. •Subjects with urinary frequency or nocturia due to cardiac or renal insufficiency and without urgency. •Subjects with severe liver insufficiency (e.g. cirrhosis, CHILD-Pugh B and C ). •Subjects with severe kidney insufficiency (Creatinin-Clearance 100/min). •Subjects with Parkinson`s disease or Alzheimer`s disease or other cerebral diseases. •Subjects being treated with other anticholinergics or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones), quinidine, tricyclic antidepressants, atropine and related compounds. •Subjects with cognitive impairment, not able to understand content and aim of the trial. •Refractory to antimuscarine treatment: Subjects having experienced no benefit from previous treatment with oral or transdermal oxybutynin. •Medical or psychological condition that would not permit completion of the trial or signing of informed consent. •Participation in other clinical trials and observation period of competing trials, respectively. •Subjects who have previously been enrolled in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial will be the treatment preference of subjects who will be asked at the end of the 2nd treatment period after both treatment phases. The preference will be checked for its plausibility in an end-of-period satisfaction rating (total of scores on 4 items of final list of questions: 6=very satisfied, 0= very dissatisfied). Treatment satisfaction will be assessed at the end of each period of the cross over. The total score on the satisfaction questionnaire of the two treatment periods will be compared to express preference.;Secondary Objective: ? Assessment of cognitive abilities during treatment with orally administered oxybutynin verus transdermal applicated Oxybutynin ? Quality of life ? Reports of AE/SAE. ? Frequency of micturition ? Frequency of urinary incontinence episodes ? Severity of urinary incontinence episodes ? Urgency frequency ? Treatment satisfaction ;Primary end point(s): Primary end point is treatment preference of the subjects who will be asked at the end of the 2nd treatment period. The preference will be checked for its plausibility in an end-of-period satisfaction rating. Treatment satisfaction will be assessed at the end of each period of the cross over. The total score on the satisfaction questionnaire of the two treatment periods will be compared to express preference. | — |
Countries
Germany
Outcome results
None listed