Comparison of Medical and Surgical Treatments of Benign Prostate Hyperplasia in Patients Who Have Low Grade Non Muscle Invasive Bladder Cancer for Tumour Recurrence and Progression

May 11, 2015 updated by: Nihat Karakoyunlu, Diskapi Teaching and Research Hospital
The purpose of this study is to compare medical and surgical treatments of benign prostate hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence and progression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Recruiting
        • Turkish Ministry of Health Dıskapı Yıldırım Beyazıt Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients who have non muscle invasive bladder cancer male patients patients between 40-80 years old

Exclusion Criteria:

  • Patients who have previous prostate surgery Patients who have muscle invasive bladder cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: First group
Patients taken tamsulosin for benign prostate hyperplasia who have non muscle invasive bladder cancer
Drug: Tamsulosin
Medical treatment for benign prostate hyperplasia
Other Names:
  • alfa blocker treatment
Active Comparator: Second Group
Patients taken transurethral resection prostatectomy for benign prostate hyperplasia who have non muscle invasive bladder cancer
Procedure: Transurethral Resection
Endoscopic treatment of bladder cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 3 years
Bladder cancer recurrence rate
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression
Time Frame: 3 years
Bladder cancer progression rate
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16.02.2015 20/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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