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Urology Database for Outcomes Research

This study is currently recruiting participants.
Verified by William Beaumont Hospitals, November 2008

Sponsored by: William Beaumont Hospitals
Information provided by: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00444730
  Purpose

The purpose of initiating the urology database is to collect relevant retrospective data via chart review related to patients undergoing radical prostatectomy via the retropubic, perineal, laparoscopic, and robotic assisted laparoscopic approaches and InterStim implantation. This data will be utilized to evaluate the health benefits and outcomes of each of these procedures to enhance care and treatment.


Condition Intervention
Prostate Cancer
Pelvic Pain
Incontinence
Procedure: Radical Prostatectomy
Procedure: InterStim Implantation

MedlinePlus related topics:   Cancer    Pelvic Pain    Prostate Cancer    Urinary Incontinence   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   Urology Database for Outcomes Research

Further study details as provided by William Beaumont Hospitals:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   3000
Study Start Date:   January 2007
Estimated Study Completion Date:   October 2029

Intervention Details:
    Procedure: Radical Prostatectomy
    Surgical procedure for prostate cancer.
    Procedure: InterStim Implantation
    surgical placement of the interstim
Detailed Description:

The objective of this study is to initiate and maintain a patient information database that will be used to study the impact of each surgical procedure on patients' overall health, quality of life, and bowel/bladder/sexual function.

The study coordinator will, on an ongoing basis, abstract needed medical information from inpatient hospital and physician office records for inclusion into the database.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

patients undergoing radical prostatectomy or InterStim implantation at William Beaumont Hospital.


Criteria

Inclusion Criteria:

  • All patients undergoing radical prostatectomy or InterStim implantation at William Beaumont Hospital.

Exclusion Criteria:

  • None
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444730

Contacts
Contact: Kaylyn Petzel, RN     248-551-3565    

Locations
United States, Michigan
William Beaumont Hospital     Recruiting
      Royal Oak, Michigan, United States, 48073
      Contact: Kaylyn Petzel, RN     248-551-3565        

Sponsors and Collaborators
William Beaumont Hospitals

Investigators
Principal Investigator:     Kenneth Peters, M.D.     William Beaumont Hospitals    
  More Information


Responsible Party:   William Beaumont Hospital ( Kenneth Peters )
Study ID Numbers:   2007-031
First Received:   March 6, 2007
Last Updated:   November 3, 2008
ClinicalTrials.gov Identifier:   NCT00444730
Health Authority:   United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Prostate Cancer  
Prostatectomy  
Pelvic pain  
urgency
incontinence
frequency

Study placed in the following topic categories:
Signs and Symptoms
Pelvic Pain
Prostatic Diseases
Genital Neoplasms, Male
Urologic Diseases
Urination Disorders
Urogenital Neoplasms
Urinary Incontinence
Pain
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Urological Manifestations
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008




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