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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

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ClinicalTrials.gov Identifier: NCT02443844
Recruitment Status : Recruiting
First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Nihat Karakoyunlu, Diskapi Teaching and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Transurethral Resection Drug: Tamsulosin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Recurrence [ Time Frame: 3 years ]
    Bladder cancer recurrence rate


Secondary Outcome Measures :
  1. Progression [ Time Frame: 3 years ]
    Bladder cancer progression rate



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02443844


Contacts
Contact: Nihat Karakoyunlu, MD 00905324747134 nkarakoyunlu@gmail.com

Locations
Turkey
Turkish Ministry of Health Dıskapı Yıldırım Beyazıt Training and Research Hospital Recruiting
Ankara, Turkey, 06110
Contact: Nihat Karakoyunlu, MD    00905324747134    nkarakoyunlu@gmail.com   
Principal Investigator: Nihat Karakoyunlu, MD         
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Principal Investigator: Nihat Karakoyunlu, MD Dıskapı TRH

Publications of Results:
Responsible Party: Nihat Karakoyunlu, MD, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT02443844     History of Changes
Other Study ID Numbers: 16.02.2015 20/03
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015

Keywords provided by Nihat Karakoyunlu, Diskapi Teaching and Research Hospital:
BPH
bladder cancer
treatment
recurrence
progression

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents