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

Sponsor

Diskapi Teaching and Research Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02443844

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Feb 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Recurrence [3 years]
Bladder cancer recurrence rate

Secondary Outcome Measures

Progression [3 years]
Bladder cancer progression rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turkish Ministry of Health Dıskapı Yıldırım Beyazıt Training and Research Hospital	Ankara		Turkey	06110

Sponsors and Collaborators

Diskapi Teaching and Research Hospital

Investigators

Principal Investigator: Nihat Karakoyunlu, MD, Dıskapı TRH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nihat Karakoyunlu, MD, Diskapi Teaching and Research Hospital

ClinicalTrials.gov Identifier:

NCT02443844

Other Study ID Numbers:

16.02.2015 20/03

First Posted:

May 14, 2015

Last Update Posted:

May 14, 2015

Last Verified:

May 1, 2015

Keywords provided by Nihat Karakoyunlu, MD, Diskapi Teaching and Research Hospital

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Tamsulosin

Study Results

No Results Posted as of May 14, 2015