A Study to Assess Efficacy and Safety With VESIcare® to Improve Urinary Continence in Subjects After Robotic Assisted Radical Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01371994
First received: June 10, 2011
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of VESIcare® versus placebo in subjects who are incontinent after Robotic Assisted Radical Prostatectomy.

This study will also assess the effect of 12 weeks of treatment with VESIcare versus placebo on quality of life (QOL) as measured by questionnaires.


Condition Intervention Phase
Urinary Incontinence
Drug: solifenacin succinate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The time from the date of first dose to the date of urinary continence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Urinary continence will be defined as the first of three consecutive 24 hour days which subject uses 0 pads, or a pad for security which remains completely dry, during the 12 week study


Secondary Outcome Measures:
  • Proportion of subjects who gain urinary continence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to each month in average daily pad usage [ Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life (QOL) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    QOL as measured by the American Urology Association Symptom Score (AUASS)

  • Change from baseline in quality of life (QOL) [ Time Frame: Bsaeleine and 12 weeks ] [ Designated as safety issue: No ]
    QOL as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

  • Change from baseline to end of study on work productivity [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Work productivity will be measured by the Work Productivity and Activity Impairment Questionnaire (WPAI)

  • Time from baseline to first day of returning to work [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 629
Study Start Date: August 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: solifenacin succinate Drug: solifenacin succinate
oral
Other Names:
  • Vesicare
  • YM905
Placebo Comparator: Placebo Drug: Placebo
oral

Detailed Description:

The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits.

Subjects will complete an electronic daily pad use diary during the study duration. Subjects will also be asked to complete several questionnaires during the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is ambulatory
  • Subject is willing and able to complete the daily pad use diary, American Urology Association Symptom Score (AUASS) with Bother Score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and the Work Productivity and Activity Impairment Questionnaire (WPAI)
  • Subject has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment
  • Subject has been diagnosed with prostate cancer, treated by Robotic Assisted Radical Prostatectomy, is voiding spontaneously and has urinary incontinence one week after removal of the indwelling catheter which requires management with 2 to 10 pads inclusive per day (24 hour days) for 7 consecutive days

Exclusion Criteria:

  • Subject has evidence of severe neurologic damage post-prostatectomy
  • Subject has evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder
  • Subject is symptomatic for urinary tract infection or has a urine culture result which requires treatment as determined by the investigator.
  • Subject has a clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in ALT, AST or creatinine clearance < 30 ml/min)
  • Subject has history of diagnosed gastrointestinal obstruction disease
  • Subject has any prior history of local radiation therapy to the prostate or rectum or any prior hormonal therapy or has planned such therapy during study conduct
  • Subject has known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
  • Subject has been treated with any investigational drug within last 30 days
  • Subject has a history of a clinically significant illness or medical condition that would preclude participation in the study
  • Subject has been diagnosed with New York Heart Association Class III and IV heart failure
  • Subject has the following peri-operative laboratory results: ALT > 2.0 ULN, AST > 2.0 ULN, serum creatinine > 1.5 mg/L, blood glucose > 130 mg/dL, BUN > 23 mg/dL.
  • Subject has severe hypertension on peri-operative evaluation which is defined as a sitting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, and which is not corrected
  • Subject has electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Subject can be eligible if electrolytes are corrected to within normal range prior to randomization
  • Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of Screening
  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: NCT01371994

  Show 60 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01371994     History of Changes
Other Study ID Numbers: 905-UC-050
Study First Received: June 10, 2011
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Radical Robotic Arm
Post Prostatectomy Incontinence
Vesicare
YM905

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014