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


N/A
18 Years
80 Years
Not Enrolling
Male
Incontinence

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Continence

Outcome Description:

Time in days to achieve pad free urinary continence

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Thomas Ahlering, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine

Authority:

United States: Institutional Review Board

Study ID:

2007-5720

NCT ID:

NCT00581061

Start Date:

June 2008

Completion Date:

February 2010

Related Keywords:

  • Incontinence
  • Incontinence
  • Robotic Prostatectomy
  • Urinary Incontinence

Name

Location
University of California, Irvine Medical Center Orange, California  92868