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

NCT ID: NCT01215721

Last Updated: 2014-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-05-31

Brief Summary

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vesicare

Vesicare 5mg daily for 90 days was prescribed for men presenting with post-Robotic Assisted Radical Prostatectomy (RARP) severe incontinence.

Group Type: EXPERIMENTAL

Vesicare

Intervention Type: DRUG

5 mg daily

Interventions

Vesicare

5 mg daily

Intervention Type: DRUG

Other Intervention Names

Vesicare (Solifenacin)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Thomas E. Ahlering

Urology Account Contact

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Ahlering, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

Related Links

http://www.urology.uci.edu

Department of Urology \| University of California, Irvine

Other Identifiers

2007-5720-2

Identifier Type: -

Identifier Source: org_study_id