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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505439
• Other study ID #: VENUS-MUI
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2012
• Last updated: June 13, 2016
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2016
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urgency Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• solifenacin
oral

Locations

Country	Name	City	State
Korea, Republic of	Site KR00001	Chonam
Korea, Republic of	Site KR00002	Chungnam
Korea, Republic of	Site KR00003	Daegu
Korea, Republic of	SIte KR00004	Incheon
Korea, Republic of	Site KR00005	Pusan
Korea, Republic of	Site KR00006	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Jeong Gu Lee	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12		Baseline and week 12	No
Secondary	Percent change in the mean number of urge urinary incontinence episodes per 24 hours		Baseline, week 4 and week 12	No
Secondary	Change in the mean number of urge urinary incontinence episodes per 24 hours	urgency episodes: defined as those with a Bladder Sensation Scale rating of = 3 in the voiding diary	Baseline, week 4 and week 12	No
Secondary	Change in the mean frequency of urination per 24 hours		Baseline, week 4 and week 12	No
Secondary	Percent change in the mean frequency of urination		Baseline, week 4 and week 12	No
Secondary	Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours		Baseline, week 4 and week 12	No
Secondary	Change in the mean number of severe urgency episodes per 24 hours	severe urgency episodes: defined as those with a Bladder Sensation Scale rating of = 4 in the voiding diary	Baseline, week 4 and week 12	No
Secondary	Changes in overactive bladder symptom score (OABSS) questionnaire	Change in total and each of OABSS items	Baseline, week 4 and week 12	No
Secondary	Changes in short urogenital distress inventory (UDI-6)	Change in total and each UDI-6 items	Baseline, week 4 and week 12	No
Secondary	Changes in short incontinence impact questionnaire (IIQ-7)	Change in total and each of IIQ-7 items	Baseline, week 4 and week 12	No
Secondary	Safety assessed by the incidence and severity of side effects		For 12 weeks	No