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

Phase 4

Completed

• Conditions: Urinary Bladder, Overactive; Overactive Bladder
• Interventions: Drug: Solifenacin

• Registration Number: NCT00979472
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with urgency	Solifenacin	-
without urgency	Solifenacin	-

Primary Outcome Measures

Name	Time	Method
change of micturition frequency on a 3-day voiding diary	after 12-week treatment

Secondary Outcome Measures

Name	Time	Method
change in patient's perception of bladder condition	after 12-week treatment
change in OAB symptom scores	after 12-week treatment
patient's satisfaction with the treatment	after 12-week treatment