Urology Database for Outcomes Research - Tabular View

Tracking Information

First Received Date ^ICMJE

March 6, 2007

Last Updated Date

May 4, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00444730 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Urology Database for Outcomes Research

Official Title ^ICMJE

Urology Database for Outcomes Research

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Prostate Cancer
Pelvic Pain
Incontinence

Intervention ^ICMJE

Procedure: Radical Prostatectomy
Procedure: InterStim Implantation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

3000

Estimated Completion Date

October 2029

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

None

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kaylyn Petzel, RN

248-551-3565

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00444730

Responsible Party

Kenneth Peters, William Beaumont Hospital

Study ID Numbers ^ICMJE

2007-031

Study Sponsor ^ICMJE

William Beaumont Hospitals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kenneth Peters, M.D.

William Beaumont Hospitals

Information Provided By

William Beaumont Hospitals

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP