Evaluation of the incidence of erectile dysfunction after TURP surgery by monopolar and bipolar methods
Design
Clinical trial with two parallel groups of monopolar and bipolar and double-blind and randomized with Excel software on 229 patients
Settings and conduct
The study was performed in Al-Zahra Hospital in Isfahan. Patients who were candidates for prostate surgery underwent turp under either monopolar or bipolar methods. Nesbit method was used for resection. Patients and patient data collector were blind to the patient group
Participants/Inclusion and exclusion criteria
Admission requirements: People over the age of 50 who need prostate resection surgery who are sexually active and have regular sex with a sexual partner
Conditions of non-entry: having a urethral catheter for more than one month; high psa (prostate specific antigen)
Intervention groups
Monopolar group:
Prostate resection in this group is performed using a 26 french monoplar resectoscope.
Bipolar Group:
Prostate resection in this group is performed using a 26 french bipolar resectoscope
Main outcome variables
Patients 'IIEF score and patients' erectile function after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210212050335N1
Registration date:2021-04-07, 1400/01/18
Registration timing:prospective
Last update:2021-04-07, 1400/01/18
Update count:0
Registration date
2021-04-07, 1400/01/18
Registrant information
Name
masoud sadat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 0130
Email address
sm.sadat155@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Transurethral Resection of the Prostate monopolar VS bipolar on Erectile Function in Patients with Benign Prostatic Hyperplasia
Public title
The Effect of Transurethral Resection of the Prostate monopolar VS bipolar on Erectile Function in Patients with Benign Prostatic Hyperplasia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
married
sexual active
continuous sexual activity with one partner
have indication for benign prostatic hyperplasia surgery
Exclusion criteria:
Age
From 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
219
Randomization (investigator's opinion)
Randomized
Randomization description
The study population was randomly divided into two groups.
Randomization was performed by simple method. It was an individual randomization unit. A list of random numbers made with computer statistical software was used. Due to the fact that patients underwent general anesthesia during the operation, they were unaware of the device used for prostate resection. It was not possible to blind the surgeon. However, the collectors of data on sexual function before and after the operation and the analyzers of the data were blind to the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient was unaware of prostate resection (monopolar or bipolar)
The person collecting the information is also unaware of the surgical procedure performed on each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Al-Zahra Hospital, Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8916885675
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.MUI.MED.REC.1399.121
Health conditions studied
1
Description of health condition studied
Erectile dysfunction, benign prostate hyperplasia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patients' erectile function score based on IIEF15 questionnaire
Timepoint
Before surgery, 6 weeks and 6 months after surgery
Method of measurement
Questionnaire IIEF15
Secondary outcomes
empty
Intervention groups
1
Description
All operations were performed by a single surgeon. Monopolar TURP was performed in the first group and Bipolar TURP was performed in the second group. In both groups, the procedure was performed by routine Nesbit method. The current setting used for resection in the monopolar system was cut / coag 110/80 and for resection in the bipolar system was cut / coag 120/80. In both procedures, a 26-french continuous-flow resctoscope was used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital of Isfahan
Full name of responsible person
MohammadHatef Khorrami
Street address
Al-Zahra Hospital, Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8916885674
Phone
+98 31 3620 2020
Email
sm.sadat155@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Toghyani
Street address
Al-Zahra Hospital, Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8916885673
Phone
+98 35 3823 0130
Email
sm.sadat155@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Masoud Sadat
Position
Specialist Assistant in Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
N0.443, Ahmadi Roushan 2, Ebne Sina Blvd
City
yazd
Province
Yazd
Postal code
8915888276
Phone
+98 35 3823 0130
Email
sm.sadat155@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Masoud Sadat
Position
Specialist Assistant in Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
N0.443, Ahmadi Roushan 2, Ebne Sina Blvd
City
yazd
Province
Yazd
Postal code
8915888276
Phone
+98 35 3823 0130
Email
sm.sadat155@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Masoud Sadat
Position
Specialist Assistant in Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
N0.443, Ahmadi Roushan 2, Ebne Sina Blvd
City
yazd
Province
Yazd
Postal code
8915888276
Phone
+98 35 3823 0130
Email
sm.sadat155@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD