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

Sponsor

Jeong Gu Lee (Other)

Overall Status

Completed

CT.gov ID

NCT01505439

Collaborator

Astellas Pharma Korea, Inc. (Industry)

311

Enrollment

Locations

Arm

Duration (Months)

51.8

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Urgency Urinary Incontinence	Drug: solifenacin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

311 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Open Label, Single Arm, Multicenter Study to Estimate the Efficacy and Safety of Solifenacin in Female With Clinically Significant Stress Urinary Incontinence and Urgency Urinary Incontinence

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Solifenacin group Once daily	Drug: solifenacin oral Other Names: Vesicare

Arm

Intervention/Treatment

Experimental: Solifenacin group

Once daily

Drug: solifenacin

oral

Other Names:

Vesicare

Outcome Measures

Primary Outcome Measures

Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12 [Baseline and week 12]

Secondary Outcome Measures

Percent change in the mean number of urge urinary incontinence episodes per 24 hours [Baseline, week 4 and week 12]
Change in the mean number of urge urinary incontinence episodes per 24 hours [Baseline, week 4 and week 12]
urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 3 in the voiding diary
Change in the mean frequency of urination per 24 hours [Baseline, week 4 and week 12]
Percent change in the mean frequency of urination [Baseline, week 4 and week 12]
Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours [Baseline, week 4 and week 12]
Change in the mean number of severe urgency episodes per 24 hours [Baseline, week 4 and week 12]
severe urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 4 in the voiding diary
Changes in overactive bladder symptom score (OABSS) questionnaire [Baseline, week 4 and week 12]
Change in total and each of OABSS items
Changes in short urogenital distress inventory (UDI-6) [Baseline, week 4 and week 12]
Change in total and each UDI-6 items
Changes in short incontinence impact questionnaire (IIQ-7) [Baseline, week 4 and week 12]
Change in total and each of IIQ-7 items
Safety assessed by the incidence and severity of side effects [For 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Site KR00001	Chonam	Korea, Republic of
2	Site KR00002	Chungnam	Korea, Republic of
3	Site KR00003	Daegu	Korea, Republic of
4	SIte KR00004	Incheon	Korea, Republic of
5	Site KR00005	Pusan	Korea, Republic of
6	Site KR00006	Seoul	Korea, Republic of