Back to resultsComparison 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
Primary Purpose
Bladder Cancer
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Transurethral Resection
Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring BPH, bladder cancer, treatment, recurrence, progression
Eligibility 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
Sites / Locations
- Turkish Ministry of Health Dıskapı Yıldırım Beyazıt Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
First group
Second Group
Arm Description
Patients taken tamsulosin for benign prostate hyperplasia who have non muscle invasive bladder cancer
Patients taken transurethral resection prostatectomy for benign prostate hyperplasia who have non muscle invasive bladder cancer
Outcomes
Primary Outcome Measures
Recurrence
Bladder cancer recurrence rate
Secondary Outcome Measures
Progression
Bladder cancer progression rate
Full Information
NCT ID
NCT02443844
First Posted
April 28, 2015
Last Updated
May 11, 2015
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02443844
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
BPH, bladder cancer, treatment, recurrence, progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
First group
Arm Type
Active Comparator
Arm Description
Patients taken tamsulosin for benign prostate hyperplasia who have non muscle invasive bladder cancer
Arm Title
Second Group
Arm Type
Active Comparator
Arm Description
Patients taken transurethral resection prostatectomy for benign prostate hyperplasia who have non muscle invasive bladder cancer
Intervention Type
Procedure
Intervention Name(s)
Transurethral Resection
Intervention Description
Endoscopic treatment of bladder cancer
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
alfa blocker treatment
Intervention Description
Medical treatment for benign prostate hyperplasia
Primary Outcome Measure Information:
Title
Recurrence
Description
Bladder cancer recurrence rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression
Description
Bladder cancer progression rate
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nihat Karakoyunlu, MD
Phone
00905324747134
Email
nkarakoyunlu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
Organizational Affiliation
Dıskapı TRH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turkish Ministry of Health Dıskapı Yıldırım Beyazıt Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
Phone
00905324747134
Email
nkarakoyunlu@gmail.com
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23170127
Citation
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.
Results Reference
result
Learn more about this trial
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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