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

Asan Medical Center

Status and phase

Completed

Phase 4

Conditions

Urinary Bladder, Overactive

Overactive Bladder

Treatments

Drug: Solifenacin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00979472

VC-2009-0014

Details and patient eligibility

About

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

Enrollment

291 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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