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

NCT00581061 | Terminated Results DMC

• 1 other identifier: 2007-5720
• Study Type: interventional
• Target: 13
• 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.

Conditions

Incontinence

Keywords

Incontinence; Robotic Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Time to Continence

  Time in days to achieve pad free urinary continence

  12 months

Secondary Outcomes (2)

• Compliance

  3 months

• Side Effects

  3 months

Study Arms (1)

Vesicare Treatment

EXPERIMENTAL

Drug: Vesicare

Interventions

Vesicare DRUG

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

Also known as: Solifenacin

Vesicare Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men diagnosed with prostate cancer undergoing robotic radical prostatectomy
• Incontinence
• Obesity
• Large prostate weight
• Mild and severe AUA symptom scores
• Urinary Bother

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)

Sponsors & Collaborators

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

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Doug Skarecky
• Organization: University of California, Irvine

dwskarec@uci.edu

714-456-6744

Study Officials

• Thomas Ahlering, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Study Start: June 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2010
• Last Updated: October 7, 2010
• Results First Posted: September 30, 2010

Record last verified: 2010-10

Locations

US (1)