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Urology Database for Outcomes Research

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444730
First Posted: March 8, 2007
Last Update Posted: August 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
  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:


Further study details as provided by Kenneth Peters, MD, William Beaumont Hospitals:

Enrollment: 860
Study Start Date: January 2007
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Radical Prostatectomy
    Surgical procedure for prostate cancer.
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00444730     History of Changes
Other Study ID Numbers: 2007-031
First Submitted: March 6, 2007
First Posted: March 8, 2007
Last Update Posted: August 28, 2014
Last Verified: August 2014

Keywords provided by Kenneth Peters, MD, William Beaumont Hospitals:
Prostate Cancer
Prostatectomy
Pelvic pain
urgency
incontinence
frequency

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