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

NCT01215721 | Completed Results DMC

• 1 other identifier: 2007-5720-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Incontinence; Robotic Prostatectomy; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Continence

  Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.

  12 months

Study Arms (1)

Vesicare

EXPERIMENTAL

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

Drug: Vesicare

Interventions

Vesicare DRUG

5 mg daily

Also known as: Vesicare (Solifenacin)

Vesicare

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Links

• Department of Urology \| University of California, Irvine

MeSH Terms

Conditions

Urinary Incontinence; Prostatic Neoplasms

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

One limitation of this study was finding a reasonable Control group. This is problematic as symptoms that definitively identify detrusor overactivity preoperatively don't exist; hence we used pad usage 7 dys post catheter removal as a surrogate.

Results Point of Contact

• Title: Thomas Ahlering, MD
• Organization: UC Irvine

tahlerin@uci.edu

714-456-6068

Study Officials

• Thomas Ahlering, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Account Contact

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 23, 2014
• Results First Posted: January 23, 2014

Record last verified: 2013-12

Locations

US (1)