Objectives: comparison the results of monopolar TURP with bipolar TURP at 6 months follow-up.
Design: This study is a single blinded (patient is blinded) randomized controlled trial which is conducted amongst 94 patients candidate for TURP surgery who are referred to Golestan Hospital which is governed by Ahvaz Jundishapur University of Medical Sciences.
Inclusion criteria: patients with BPH without any previous procedure on the urethra or Prostate؛ patients with BPH without any history of urethral stricture.
Exclusion criteria: the existence of bladder stone; large bladder diverticula; diagnosis of Prostate cancer in final pathology.
the patients are randomly assigned to two groups; group B that undergo bipolar TURP and group M that undergo monopolar TURP. Before the study, the severity of Lower Urinary Tract Symptoms (LUTS) and erectile function are evaluated by using of IPSS questionnaire and IIEF-5 questionnaire. Catheterisation time and hospital stay are recorded postoperatively, and 3 and 6 months after surgery the LUTS and erectile function will be evaluated by using of IPSS and IEF-5 questionnaires. In addition, the incidence of urethral stricture and reoperation rate will be evaluated along 6 months follow-up.
General information
Acronym
Trans Urethral Resection of Prostate(TURP)
IRCT registration information
IRCT registration number:IRCT2017060234301N1
Registration date:2017-08-11, 1396/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-11, 1396/05/20
Registrant information
Name
Jahanbakhsh Rahimi zadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3335 6789
Email address
rahimizadeh.j@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision study of Bipolar versus Monopolar transurethral resection of prostate in patients with benign prostatic hyperplasia
Public title
Bipolar versus Monopolar technique in Transurethral resection of Prostate(TURP)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with BPH without any previous procedure on the urethra or Prostate؛ patients with BPH without any history of urethral stricture.
Exclusion criteria: the existence of Bladder stone; large bladder diverticula; diagnosis of Prostate cancer in final pathology.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
after enrollment of patients in the study by using inclusion and exclusion criteria, simple randomization was performed with Winpepi application
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ethics committee of Ahvaz Jundishapur University of Medical Sciences, Farvardin st., Golestan blv., Ahvaz
City
Ahvaz
Postal code
00986193673166
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.Ajums.REC.1396.181
Health conditions studied
1
Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N41
ICD-10 code description
HYPERPLASIA OF PROSTATE
Primary outcomes
1
Description
lower urinary tract symptoms
Timepoint
Before and, 3 and 6 month after surgery
Method of measurement
IPSS Questioneir
2
Description
Erectile function
Timepoint
Before surgery, 3 month and 6 month after surgery
Method of measurement
IIEF-5 Questioneir
3
Description
Urethral Stricture
Timepoint
Along 6 month after surgery
Method of measurement
Retrograde Urethragraphy(RUG)
4
Description
Reoperation
Timepoint
Along 6 month after surgery
Method of measurement
Cases
Secondary outcomes
1
Description
Hemoglobin(Hb)
Timepoint
Before and after surgery
Method of measurement
Laboratory
2
Description
Catheterisation Time
Timepoint
After surgery
Method of measurement
Dayes
3
Description
Hospital stay
Timepoint
After surgery
Method of measurement
Dayes
4
Description
Blood Na
Timepoint
befor and aftersurgery
Method of measurement
Laboratory
Intervention groups
1
Description
Transurethral resection of Prostate with bipolar technology: In this surgery, by using of a resectoscope the prostate is resected, transurethrally.In this surgical technique bipolar electrical source and bipolar loop are used and irrigation solution is Isotonic.
Category
Treatment - Surgery
2
Description
Transurethral resection of Prostate with Monopolar technology:
in this surgical technique by using of a resectoscope the prostate is resected, transurethrally.in this method , Monopolar loop and Monopolar electrical source are used and errigation solution is hypotonic.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Dr.Esmaeel Mosapour
Street address
Farvardin street, Golestan blv., Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur Universtlity of Medical Sciences
Full name of responsible person
Dr.behzad sharif makhmalzadeh
Street address
Vice chancellor for research, Jundishapur University of Medical sciences, Farvardin street, Golestan blv., Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur Universtlity 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Jahanbakhsh Rahimizadeh
Position
Urology Resident
Other areas of specialty/work
Street address
Urology ward of Golestan Hospital, Farvardin St., Golestan blv. Ahvaz
City
Ahvaz
Postal code
00986193673166
Phone
+98 61 3374 3011
Fax
Email
sam136570@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Esmaeel Musapour
Position
Urologist
Other areas of specialty/work
Street address
Urology ward of Golestan Hospital, Farvardin st. Golestan blv. Ahvaz
City
Ahvaz
Postal code
00986193673166
Phone
+98 61 3374 3011
Fax
Email
emosapour@yahoo.com; sam136570@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Jahanbakhsh Rahimizadeh
Position
Urology Resident
Other areas of specialty/work
Street address
Urology Ward of Golestan Hospital, Farvardin St. Golestan blv. Ahvaz
City
Ahvaz
Postal code
00986193673166
Phone
+98 61 3374 3011
Fax
Email
sam136570@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)