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

NCT02443844 | Unknown Phase 4

• 1 other identifier: 16.02.2015 20/03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

BPH; bladder cancer; treatment; recurrence; progression

Outcome Measures

Primary Outcomes (1)

• Recurrence

  Bladder cancer recurrence rate

  3 years

Secondary Outcomes (1)

• Progression

  3 years

Study Arms (2)

First group

ACTIVE COMPARATOR

Patients taken tamsulosin for benign prostate hyperplasia who have non muscle invasive bladder cancer

Drug: Tamsulosin

Second Group

ACTIVE COMPARATOR

Patients taken transurethral resection prostatectomy for benign prostate hyperplasia who have non muscle invasive bladder cancer

Procedure: Transurethral Resection

Interventions

Transurethral Resection PROCEDURE

Endoscopic treatment of bladder cancer

Second Group

Tamsulosin DRUG

Medical treatment for benign prostate hyperplasia

Also known as: alfa blocker treatment

First group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Turkish Ministry of Health Dıskapı Yıldırım Beyazıt Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Li S, Zeng XT, Ruan XL, Wang XH, Guo Y, Yang ZH. Simultaneous transurethral resection of bladder cancer and prostate may reduce recurrence rates: A systematic review and meta-analysis. Exp Ther Med. 2012 Oct;4(4):685-692. doi: 10.3892/etm.2012.660. Epub 2012 Aug 9.

  PMID: 23170127 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Recurrence; Disease Progression

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Nihat Karakoyunlu, MD

  Dıskapı TRH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nihat Karakoyunlu, MD

CONTACT

00905324747134; nkarakoyunlu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 14, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2020
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

TU (1)