To evaluate and compare prostate capsule sparing and nerve sparing radical cystectomy impact on the oncological and functional outcomes of patients with muscle invasive bladder tumors
Design
All the patients were sexually active preoperatively (IIEF-5=22-25). The postoperative sexual function and continence were assessed by the International Index of Erectile Function (IIEF-15) and International Consultation on Incontinence Questionnaire (ICIQ) respectively and compared in groups A and B.
Settings and conduct
Between March, 2016 and September 2019, 60 men with muscle invasive bladder tumor who were candidate for sexual preserving radical cystectomy and orthotopic urinary diversion were included in this study. The cases were randomized in two groups. Nerves sparing radical cystectomy and prostate capsule sparing radical cystectomy.
Participants/Inclusion and exclusion criteria
men with muscle invasive bladder tumor who were candidate for sexual preserving radical cystectomy and orthotopic urinary diversion
Intervention groups
Nerves sparing radical cystectomy and prostate capsule sparing radical cystectomy
Main outcome variables
IIEF-15 (international index of erectile function)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211208053328N1
Registration date:2022-01-02, 1400/10/12
Registration timing:retrospective
Last update:2022-01-02, 1400/10/12
Update count:0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Hossein Bahrami Samani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
bahrami.hossein1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2019-09-30, 1398/07/08
Actual recruitment start date
2016-03-01, 1394/12/11
Actual recruitment end date
2019-09-30, 1398/07/08
Trial completion date
2019-09-30, 1398/07/08
Scientific title
Sexual sparing radical cystectomy: nerve sparing versus prostate capsule sparing
Public title
Sexual sparing radical cystectomy: nerve sparing versus prostate capsule sparing
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
candidate for sexual sparing radical cystectomy and orthotopic urinary diversion
organ-confined diseases
absence of any kind of tumor at the level of the prostate, prostatic urethra or bladder neck
patients who are sexually active and enthusiastic to save their sexual functions
Exclusion criteria:
Age
From 49 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by Randomizer software (Fahmy Corporation version 2016.6.0.56). It should be noted that patients are not aware of the procedure performed and the allocation is done secretly.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Vice Chancellor for Research and Technology, Hezar Jerib St.sfahan University of Medical Sciences and Health Services, Building No. 4
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.MUI.MED.REC.1399.248
Health conditions studied
1
Description of health condition studied
Sexual sparing radical cystectomy
ICD-10 code
N52.32
ICD-10 code description
Erectile dysfunction following radical cystectomy
Primary outcomes
1
Description
international index of erectile function (IIEF)
Timepoint
6 months, 1 year and 2 years after surgery
Method of measurement
ICIQ (international consultation on incontinence questionnaire) and IIEF-15 (international index of erectile function)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Removal of bladder, prostate, seminal vesicle, vas deferens and pelvic lymph node lymphadenectomy will be performed with special attention to neurovascular bundles on the lateral edge of the prostate. All the principles of saving neurovascular bundles will be considered.
Category
Treatment - Surgery
2
Description
Intervention group: The prostate adenoma will be enucleated like Millin procedure and the capsule will be preserved for the neo-bladder anastomosis.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hossein Bahrami Samani
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
2
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Hossein Bahrami Samani
Street address
Khorshid Hospital, Ostandari st.
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Vice Chancellor for Research and Technology, Hezar Jerib St.sfahan University of Medical Sciences and Health Services, Building No. 4,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
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
Hossein Bahrami Samani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
bahrami.hossein1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Bahrami Samani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
bahrami.hossein1993@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Bahrami Samani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
bahrami.hossein1993@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
Information is kept confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared
When the data will become available and for how long
After publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to complete studies
From where data/document is obtainable
Dr. Hossein Bahrami Samani, Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
By examining the researcher's request and providing sufficient documentation of his research and the reason for using the data can be provided