solifenacin flexible dosing study in frequent micturition patients with and without urgency

Conditions: Urinary Bladder, Overactive; Overactive Bladder

Summary: the purpose of the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency.


Eligibility criteria:
inclusion criteria: * for the without-urgency group: * urinary frequency ≥ 8 micturitions per 24 hours no urgency on voiding diary (1 or 2 on a 5 urgency scale) * for the with-urgency group: * urinary frequency ≥ 8 micturitions per 24 hours symptoms of urinary urgency≥ 2/day on the voiding diary (3 to 5 on a 5 urgency scale) * symptoms lasting for more than 3 months exclusion criteria: * clinically significant stress incontinence as determined by the investigator; for female patients, clinically significant stress incontinence confirmed by a cough provocation test * total daily urine volume of \> 3000 ml as verified on the micturition diary before randomization * significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotra * any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention * symptomatic acute urinary tract infection (uti) during the run-in period * recurrent utis defined as having been treated for symptomatic utis \> 4 times in the last year * diagnosed or suspected of interstitial cystitis * uninvestigated hematuria or hematuria secondary to a malignant disease * clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care (residual urine\> 100ml of functional bladder capacity) * patients with marked cystocele or other clinically significant pelvic prolapse * treatment within 14 days preceding randomization, or expected to initiate treatment during the study with: * any anticholinergic drugs other than a randomized trial drug * any drug treatment for overactive bladder. estrogen treatment started more than 2 months prior to inclusion is allowed * on an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study * receipt of any electrostimulation or bladder training within 14 days before randomization, or expected to start such treatment during the study * an indwelling catheter or practicing intermittent self-catheterization * use of any investigational drug within 1 month prior to the start of the study * patients with chronic constipation or history of severe constipation * pregnant or nursing women * sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to the start of the study and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. reliable contraceptive methods are defined as intrauterine devices (iuds), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy) * patients who have bladder cancer or prostate cancer * treatment with potent cyp3a4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole) * patients who have neurological disease * patients who have psychological disease * any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Keywords: solifenacin overactive bladder micturition urinary urgency vesicare