Randomized, double-blind, placebo-controlled, parallel group study of vardenafil 10 mg twice daily to assess the effect on urodynamics in patients with Overactive Bladder (detrusor overactivity).
- Conditions
- Overactive bladder (detrusor overactivity)MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder
- Registration Number
- EUCTR2006-005145-11-CZ
- Lead Sponsor
- Bayer Healthcare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
•Male and female patients aged > 18 years. Women must either be aged > 55 years being menopausal since at least 12 months, or must use an adequate birth control method (Note: as adequate method of birth control hormonal contraception, sterilization, spiral/IUD or sexual abstinence is recommended. Furthermore, double-barrier methods consisting of two of the following measures may be considered at the discretion of the investigator: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
•Diagnosis of Overactive Bladder (OAB), with and without urge incontinence, for at least six months prior to Visit 1
•At least one out of the three criteria below (to be assessed at Visit 2):
oEntire bladder capacity (= maximum cystometric bladder capacity) < 300 mL.
OR
oIn accordance with ICS-guidelines: Detrusor overactivity as defined as spontaneous involuntary detrusor contraction during filling phase
OR
oDetrusor contraction during filling phase leading to involuntarily initiated micturition before a normal bladder capacity is reached.
•Symptoms of OAB are to be assessed during the unmedicated run-in by a 7-day micturition diary (in-between Visits 1 and 2).
oEach patient must show on average over all days documented:
?at least 8 micturitions per day and
?at least 1 urgency episode per day
oEach patient must document a minimum of 3 consecutive days out of 7 days.
•Patients capable of understanding the given information and having signed and dated written Patient Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits
•Patients able to swallow the study medication in accordance with 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Concomitant Medication
•Drugs known to affect urinary bladder function (e.g. anticholinergics, antispasmodics, serotonin-noradrenalin-reuptake-inhibitors) 21 days prior to Visit 2 and during study
•Solifenacin 28 days prior to Visit 2 and during study
•Botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 2 and during study
•Cholinergic agonists and cholinesterase inhibitors, e.g. bethanecol, donepezil, rivastigmine
•Nitrates or nitric oxide donors
•PDE5 inhibitors within 7 days prior to Visit 1
•Alpha-blockers
•potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole and ketoconazole (topical forms allowed) or erythromycin or clarithromycin.
•Acenocumarol or heparin.
•Drugs known to prolong the QT interval, eg Class IA (eg quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics
•Androgens
Previous or Current Medical Conditions - General
•Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study
•Loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION)
•Hereditary degenerative retinal disorders such as retinitis pigmentosa
•Any severe cardiovascular condition including unstable angina pectoris and severe myocardial insufficiency defined as stages III or IV according to NYHA-classification
•History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
•Congenital QT prolongation
•Left ventricular outflow obstruction, e.g .due to Aortic valve disorder
•Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate = 100 bpm).
•Resting hypotension (resting systolic blood pressure of < 90 mm Hg) or hypertension (resting systolic blood pressure > 170 mm Hg or resting diastolic blood pressure > 110 mm Hg).
•Symptomatic postural hypotension within 6 months of Visit 1
•History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
•Significant active peptic ulceration
•Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
•In men: Clinically significant chronic haematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma and leukemia
•History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
•Bleeding disorder
Previous or Current Medical Conditions – Urinary Tract
•Bladder fibrosis (low compliance and detrusor hyporeflexia/hypocontractility), detrusor-sphincter-dyssynergia (DSD), detrusor hyporeflexia/areflexia and bradykinesia/tremor of the external urethral sphincter
•Males with post-void residual (PVR) urinary volume >150 mL at Baseline
•Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator
•History of secondary vesico-uretheral reflux
•Chronic persistent local pathology that in the opinion of the investigator may lead to urinary symptoms, such as one of the genito-urinary pain syndromes, interstitial cystitis
•Urolithiasis
•Unexplained macro- and micro-hematuria, as determined by the investigator
•Any urogenital surgery (includin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method