A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

Jeong Gu Lee

Status and phase

Completed

Phase 4

Conditions

Stress Urinary Incontinence

Urgency Urinary Incontinence

Treatments

Drug: solifenacin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01505439

VENUS-MUI

Details and patient eligibility

About

This study is to investigate the effects of solifenacin on urgency urinary incontinence symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically significant stress urinary incontinence accompanied by urgency urinary incontinence.

Enrollment

311 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients are selected from those who meets one of criteria
Patients with a positive cough provocation test
Based on 3-day voiding diary, patients with:
- Urinary frequency (eight or more micturitions per day or 24 hours)
- Urinary urgency (two or more episodes per day or 24 hours)
- Urge incontinence (three or more episodes for 3 days)

Exclusion criteria

Breast-feeding women or females of childbearing potential with the intention to become pregnant during the study
Post-void residual urine volume (PRV) of 150 cc or more
Patients who experienced acute ureteral obstruction requiring an indwelling catheter
Patients who experienced clinically significant pelvic organ prolapse or lower urinary tract surgery within 6 months prior to the initiation of the present study
Patients who underwent a urinary incontinence operation within 1 year
Any condition that, in the opinion of the investigator, is a contraindication for anticholinergic treatment, including severe narrow-angled glaucoma, urinary retention, gastric retention, severe myasthenia, severe hepatic insufficiency or severe ulcerative colitis
Significant hepatic or renal disease, defined as having greater than twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine
Patients who have any of neurological disorders such as stroke, multiple sclerosis, spinal cord injury, and Parkinson's disease
Patients who use an indwelling catheter or practice intermittent self-catheterization
Recurrent UTIs defined as having been treated for symptomatic UTIs 3 times or more in the last year
Symptomatic acute urinary tract infection (UTI) during the run-in period
Patients who received any of the following prohibited concomitant drugs within 14 days prior to randomization: Treatment performed within the 14 days preceding randomization, or expected to initiate treatment during the study with:
- Any anticholinergics other than the trial drug
- Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed
Patients taking an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
Patients with chronic constipation or history of severe constipation
Treatment with any of potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole)
Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study initiation 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, surgical procedures (tubal ligation or vasectomy), or continence
Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion