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Urology Database for Outcomes Research

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00444730
First received: March 6, 2007
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  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
Procedure: Pelvic organ prolapse repair

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Urology Database for Outcomes Research

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Estimated Enrollment: 3000
Study Start Date: January 2007
Estimated Study Completion Date: October 2029
Intervention Details:
    Procedure: Radical Prostatectomy
    Surgical procedure for prostate cancer.
    Other Name: radical prostatectomy
    Procedure: InterStim Implantation
    surgical placement of the interstim
    Other Name: interstim
    Procedure: Pelvic organ prolapse repair
    Surgical pelvic organ prolapse repair
    Other Name: prolapse repair
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

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth Peters, M.D. William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00444730     History of Changes
Other Study ID Numbers: 2007-031
Study First Received: March 6, 2007
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pelvic Pain
Prostatic Neoplasms
Pain
Signs and Symptoms
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013