Objective: A Comparative study on Uroflowmetry Index Improvement after Open Prostatectomy and Trans-Urethral Resection of Prostate (TURP)
Material & methods: 70 patients with BPH, candidate for surgery, will randomly divided into two groups and each group will be operated by one of two methods. Uroflowmetry Before surgery and one month after the surgery will be performed and maximum and average urinary flow rate of each patient will be compared with himself and the whole groups will be compared.
Inclusion criteria:
1 - BPH patients candidate for surgery
2 - All patients should allow for open surgery or TUR-P. Exclusion criteria: 1 - Prostate weight greater than 100 g or less than 40 grams
2 - Contraindications for TURP and open prostatectomy
3 – Urinary retention (Urethral catheterized patients).
Intervention: Surgery will be performed with one of two methods. Outcome of study:
1 - Determination of mean urinary flow rate before and after attempting to open prostatectomy
2 - Determination of mean urinary flow rate before and after TUR-P
3 - Comparison of mean urinary flow rate changes in both groups
4 - Determination of prostate weight based on ultrasound before surgery
5 - Determination of sample weight removed by surgery
6 – Determination of Uroflowmetry improvement based on prostate weight before surgery and weight of prostate tissue removed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101185641N1
Registration date:2011-05-31, 1390/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-31, 1390/03/10
Registrant information
Name
Seyed Habibollah Mousavi-bahar
Name of organization / entity
Hamedan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 0829
Email address
shmbahar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study on Uroflowmetry Index Improvement after Open Prostatectomy and Trans Urethral Resection of Prostate (TURP)
Public title
Comparing two surgical methods for Benign Prostatic Hyperplasia (BPH) treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients with BPH candidated for surgery
2- All patients should be able to treat by both of TURP or Open prostatectomy. Exclusion criteria:
1- Prostate with more than 100 or less than 40 gr weight in ultrasonography
2- Contraindication for TURP or Open prostatectomy
3- Unability for lithotomy positioning
4- Small and fibrosed prostate
5- History of previous surgery for prostate
6- Prostatic carcinoma
7- Big bladder stone( more than 2 cm)
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Fahmideh St.
City
Hamedan
Postal code
518/65178
Approval date
2011-04-06, 1390/01/17
Ethics committee reference number
6/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Benign Prostatic Hypertrophy
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
Mean urine flow rate
Timepoint
1 month
Method of measurement
Uroflowmetry
Secondary outcomes
empty
Intervention groups
1
Description
TURP
Category
Treatment - Surgery
2
Description
Open prostatectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Ghaleiha
Street address
Fahmideh St.
City
Hemedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Habibollah Mousavi-bahar
Position
Chief of Urology Department, Associated Professor
Other areas of specialty/work
Street address
Urology ward, Shahid Beheshti hospital, Eram Blvd
City
Hamedan
Postal code
Phone
+98 81 1838 0283
Fax
+98 81 1838 1035
Email
shmbahar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Habibollah Mousavi-bahar
Position
Chief of Urology Department, Associated Professor
Other areas of specialty/work
Street address
Urology ward, Shahid Beheshti hospital, Eram Blvd
City
Hamedan
Postal code
Phone
+98 81 1823 0829
Fax
+98 81 1838 1035
Email
shmbahar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Habibollah Mousavi-bahar
Position
Chief of Urology Department, Associated Professor
Other areas of specialty/work
Street address
Urology Ward, Shahid Beheshti Hospital, Eram Blvd
City
Hamedan
Postal code
Phone
+98 81 1838 0283
Fax
+98 81 1838 1035
Email
shmbahar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)