Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Solifenacin Succinate

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