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

Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00581061
• Other study ID #: 2007-5720
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: October 5, 2010
• Start date: June 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incontinence

Intervention

Drug:
• Vesicare
Vesicare will be taken daily for one or three months, depending on symptoms of subject.

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Continence	Time in days to achieve pad free urinary continence	12 months	No
Secondary	Compliance	Number of subjects that were in compliance with the study protocol and took medication for at least one month.	3 months	No
Secondary	Side Effects	Number of people who experienced side effects while taking Vesicare, per study protocol.	3 months	No