Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II)

December 4, 2013 updated by: Thomas E. Ahlering, University of California, Irvine

Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy

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.

*This study has been modified from the original protocol with the clinicaltrials.gov ID: NCT00581061.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients that have been diagnosed with prostate cancer and will undergo treatment for the disease as part of standard clinical care
  • Patients that have multiple pad use a few days after standard of care catheter removal

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)
  • Lives in a different country

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vesicare
Vesicare 5mg daily for 90 days was prescribed for men presenting with post-Robotic Assisted Radical Prostatectomy (RARP) severe incontinence.
Drug: Vesicare
5 mg daily
Other Names:
  • Vesicare (Solifenacin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Continence
Time Frame: 12 months
Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Thomas Ahlering, MD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2014

Last Update Submitted That Met QC Criteria

December 4, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-5720-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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