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Study to Determine Effects of Vesicare on Return to Continence Post- Radical Prostatectomy

This study has been terminated.
(Study subjects were not compliant with study protocols.)
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581061
First received: December 21, 2007
Last updated: October 5, 2010
Last verified: October 2010
  Purpose

Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men. Radical prostatectomy is one of the treatment options available for organ-confined disease. Over 100,000 radical prostatectomies cases (total removal of the cancerous prostate by surgery) are performed in the United States yearly. Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life (QOL) scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day. Many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients symptoms may persist for longer periods.

Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability results in excess contractions of the urinary bladder ('urgency to urinate'), and can result in the feeling of needing to urinate more frequently. Consistent with this hypothesis of detrusor muscle instability, men with postoperative dribbling had more complaints with urgency, frequency and bother scores when queried with validated questionnaires. We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patient's dribbling of urine.

By treating the bladder muscle instability, we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate. This pilot study will assess the statistical requirements for the number of subjects needed for a fully 'powered' randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients' quality of urinary life and improve postoperative urinary incontinence after surgery.


Condition Intervention
Incontinence
Drug: Vesicare

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Time to Continence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time in days to achieve pad free urinary continence


Secondary Outcome Measures:
  • Compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of subjects that were in compliance with the study protocol and took medication for at least one month.

  • Side Effects [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of people who experienced side effects while taking Vesicare, per study protocol.


Enrollment: 13
Study Start Date: June 2008
Study Completion Date: February 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vesicare Treatment Drug: Vesicare
Vesicare will be taken daily for one or three months, depending on symptoms of subject.
Other Name: Solifenacin

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men diagnosed with prostate cancer undergoing robotic radical prostatectomy
  • Incontinence
  • Obesity
  • Large prostate weight
  • Mild and severe AUA symptom scores
  • Urinary Bother

Exclusion Criteria:

  • Contra-indication to Solifenacin
  • Narrow angle glaucoma
  • Hepatic impairment
  • Renal impairment
  • CYP3A4 inhibitors (e.g. Ketoconazole)
  • Gastric Retention (delayed or slow emptying of the stomach)
  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: NCT00581061

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Astellas Pharma Inc
Investigators
Principal Investigator: Thomas Ahlering, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Thomas Ahlering, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581061     History of Changes
Other Study ID Numbers: 2007-5720
Study First Received: December 21, 2007
Results First Received: March 11, 2010
Last Updated: October 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Incontinence
Robotic Prostatectomy

Additional relevant MeSH terms:
Solifenacin
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014