Estudo aleatorizado, em dupla ocultação, controlado por placebo, em grupo paralelo com vardenafil 10 mg duas vezes por dia para avaliar o efeito nas urodinâmicas em doentes com Bexiga Hiperactiva (hiperactividade do detrusor)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: Bexiga Hiperactiva (hiperactividade do detrusor)Overactive bladder (detrusor overactivity)
MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder

Registration Number: EUCTR2006-005145-11-PT

Lead Sponsor: Bayer Healthcare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 481

Inclusion Criteria

•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, doublebarrier
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):
* Entire bladder capacity (= maximum cystometric bladder capacity) = 300 mL.
OR
* In accordance with ICS-guidelines: Detrusor overactivity as defined as
spontaneous involuntary detrusor contraction during filling phase
OR
*Detrusor 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).
* Each patient must show on average over all days documented:
- at least 8 micturitions per day and
-at least 1 urgency episode per day
* Each 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

Exclusion Criteria

Conc. Medic.
•Treat. with drugs known to affect urinary bladder function (e.g. anticholinergics, antispasmodics, serotonin-noradrenalin-reuptake-inhibitors) 21 d. prior to V.2 and at any time during study
•Treat. with solifenacin 28 d. prior to V. 2 and at any time during study
•Treat. with botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to V. 2 and at any time during study
•Use of cholinergic agonists and cholinesterase inhibitors, e.g. bethanecol, donepezil, rivastigmine
•Subj. who are taking nitrates or nitric oxide donors
•Use of PDE5 inhibitors within 7 d. prior to V.1
•Pts on alpha-blockers
•Subj. who are taking the following potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin or clarithromycin.
• Treat. with acenocumarol or heparin.
• Treat. with drugs known to prolong the QT interval, eg Class IA (eg quinidine,
procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications
• Treat. with androgens
Previous or Current Med.Cond. - General
•Any unstable med., psychiatric, or substance abuse disorder that in the opinion of the Inv. 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 CV condition including unstable angina pectoris and severe
myocardial insufficiency defined as stages III or IV according to the classification of
the NY Heart Association (NYHA)
•History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
•Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate = 100 bpm).
•Resting hypotension (a resting systolic blood pressure of < 90 mmHg) or hypertension (a resting systolic blood pressure > 170 mmHg or a resting diastolic blood pressure > 110 mmHg).
•Symptomatic postural hypotension within 6 months of V.1
•History of positive test for Hep. B surface antigen (HBsAg) or Hep. C.
•Significant active peptic ulceration
•Severe chronic or acute liver disease, history of moderate (Child-PughB) 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
Pts with congenital QT prolongation
• Pts with left ventricular outflow obstruction, e.g.due to an Aortic valve disorder
Prev. or Current Medical Condit. – Urinary Tract
•Bladder fibrosis (low compliance and detru. hyporeflexia/hypocontractility), detru.-sphincter-dyssynergia, detru. 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
•Chronic persistent local pathology that in the opinion of the inv. may lead to urinary symptoms, such as one of the genito-urinary pain syndromes, interstitial cystitis
•Unexplained