Urology Database for Outcomes Research

Prostate Cancer Clinical Trial

Official title:

Urology Database for Outcomes Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444730
• Other study ID #: 2007-031
• Status: Completed
• Phase: N/A
• First received: March 6, 2007
• Last updated: August 26, 2014
• Start date: January 2007
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Incontinence
• Pelvic Pain
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Radical Prostatectomy
Surgical procedure for prostate cancer.
• InterStim Implantation
surgical placement of the interstim
• Pelvic organ prolapse repair
Surgical pelvic organ prolapse repair

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth Peters, MD	William Beaumont Hospitals

Country where clinical trial is conducted

United States,