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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Jeong Gu Lee, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01505439
First received: January 4, 2012
Last updated: June 13, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Stress Urinary Incontinence
Urgency Urinary Incontinence
Drug: solifenacin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in the mean number of urge urinary incontinence episodes per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  • Change in the mean number of urge urinary incontinence episodes per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  • Percent change in the mean frequency of urination [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  • Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
  • Change in the mean number of severe urgency episodes per 24 hours [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
    Change in total and each of OABSS items

  • Changes in short urogenital distress inventory (UDI-6) [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
    Change in total and each UDI-6 items

  • Changes in short incontinence impact questionnaire (IIQ-7) [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
    Change in total and each of IIQ-7 items

  • Safety assessed by the incidence and severity of side effects [ Time Frame: For 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 311
Study Start Date: June 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solifenacin group
Once daily
Drug: solifenacin
oral
Other Name: Vesicare

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505439

Locations
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, Korea, Republic of
Sponsors and Collaborators
Jeong Gu Lee
Astellas Pharma Korea, Inc.
  More Information

Responsible Party: Jeong Gu Lee, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT01505439     History of Changes
Other Study ID Numbers: VENUS-MUI 
Study First Received: January 4, 2012
Last Updated: June 13, 2016
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:
solifenacin
bladder symptom

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on December 06, 2016