Loop Resectoscope in Treating Patients With Bladder Cancer or Benign Prostatic Hyperplasia Who Are Undergoing Transurethral Resection

This study has been completed.

First Received: March 15, 2006 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303654

Purpose

RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer or benign prostatic hyperplasia. Transurethral resection using a loop resectoscope may have fewer side effects and improve recovery.

PURPOSE: This clinical trial is studying how well the loop resectoscope works in treating patients with bladder cancer or benign prostatic hyperplasia who are undergoing transurethral resection.

Condition	Intervention
Bladder Cancer	Procedure: biopsy Procedure: therapeutic conventional surgery

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Quality Assessment of the Roei Loop Resectoscope for Transurethral Resection of Bladder Neoplasm and BPH

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Surgeon satisfaction with usage of Roei loop resectoscope measured by a questionnaire after the surgical procedure [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	August 2005

Detailed Description:

OBJECTIVES:

Determine the efficacy, in terms of mechanical capabilities, of the Roei loop resectoscope in patients with bladder cancer or benign prostatic hyperplasia undergoing transurethral resection of bladder tumor or benign prostatic adenoma.
Determine the quality of specimens submitted for histological analysis from patients undergoing this procedure.

OUTLINE: This is an open-label, pilot study.

Patients undergo transurethral resection using the Roei loop resectoscope. Surgeon satisfaction with the Roei loop resectoscope is measured by a self-assessment questionnaire. The quality of specimens submitted for histological study are also assessed.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of bladder cancer or benign prostatic hyperplasia

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303654

Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Allan Pantuck, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000446284, UCLA-0506127-01
Study First Received:	March 15, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00303654 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent bladder cancer
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer

Study placed in the following topic categories:

Urinary Tract Neoplasm
Cystocele
Prostatic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms

Genital Diseases, Male
Recurrence
Hyperplasia
Prostatic Hyperplasia
Urologic Diseases
Bladder Neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Urologic Diseases
Prostatic Hyperplasia

Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Genital Diseases, Male
Urologic Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009