Comparison of the effect of pelvic floor myofascial release and Pelvic floor training on treatment of male erectile dysfunction in post adenectomy and radical prostatectomy
The aim of this project is to evaluate the effect of manual therapy along with exercise therapy on the erection rate of patients after adenectomy and radical prostatectomy.
Design
Clinical randomized trial with control group, with parallel groups, two-way blind, concealed, phase 2 on 80 patients, block method and random number table were used for randomization.
Settings and conduct
The study site will be the special clinic of Imam Reza Hospital in Mashhad, room 24. Patients will be treated for 10 sessions.
Participants/Inclusion and exclusion criteria
Entry conditions:
Patients in the age range of 45 to 60 years
Confirmation of erectile dysfunction duo to prostate surgery by a physician
Patients operated by retropubic technique with both adenectomy and radical methods
No entry conditions:
Having other neurological diseases and major orthopedic problems (pelvic fractures)
Taking erectile drugs such as taladafil and sildenafil
Mental problems such as depression
Intervention groups
Case group 1- Manual therapy with therapeutic practice in adenectomy surgery
Control group 1- Exercise therapy in adenectomy surgery
Case group 2- Manual therapy with therapeutic practice in radical surgery
Control group 2- Exercise therapy in radical surgery
Main outcome variables
Erection rate; Erectile condition; Maximum thickness of the ischemic vein; Area of Ischiocavernus; Maximum thickness of bulbouspongesios ; Area of bulbous sponges; Maximum cavernosal systolic velocity, minimum cavernosal diastolic velocity; Cavernosal artery diameter; Vascular resistance index; Maximum blood velocity in the posterior vein.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210809052123N1
Registration date:2022-05-08, 1401/02/18
Registration timing:registered_while_recruiting
Last update:2022-05-08, 1401/02/18
Update count:0
Registration date
2022-05-08, 1401/02/18
Registrant information
Name
Mahdi Afshar Safavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3225 7030
Email address
mahdi3068@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-06, 1401/02/16
Expected recruitment end date
2022-07-07, 1401/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pelvic floor myofascial release and Pelvic floor training on treatment of male erectile dysfunction in post adenectomy and radical prostatectomy
Public title
The effect of manual therapy on erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the absence of a secondary erection to prostate surgery by a physician
Patients operated by retropubic technique with both adenectomy and radical methods
Being married
Age range between 45 to 60 years
Exclusion criteria:
Taking erectile drugs such as taladafil and sildenafil
Mental problems such as depression
Age
From 45 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into four random groups using a random number constructor. The randomization method is simple and done individually. In order to randomize the statistics, the names of the people are entered in Excel software, then random numbers are assigned to each person using the Rand function. These numbers are then sorted from small to large using software sorting, which disrupts the order of the initial list and randomizes how people are positioned. Then, the first 20 people are considered for the treatment group of adenectomy patients, the second 20 people are considered for the control group of adenectomy surgery, the third 20 people are considered for the treatment group of radical patients and the fourth 20 people are considered for the control group of radical patients. Randomization of patients was done by a statistical consultant and the groups will be determined based on number 1 for the treatment group of adenectomy patients, number 2 for the control group of adenectomy surgery, number 3 for the treatment group of radical patients and number 4 for the control group of radical patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
1- Participants: In the case group, the application of the manual technique is performed in a real way, while in the control group, only a superficial touch is performed and the therapeutic exercise component is performed in the same way in both.
2- Data Analyzer: The data analyzer will use code to analyze the data in such a way that it is unaware of its content.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Outcome will be measured at both the beginning and end of treatment
Method of measurement
Erection hardness score
2
Description
Erection index
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
International index of erectile function Questionnaire
3
Description
Maximum thickness of Ischiocavernus
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
measured by two-dimensional ultrasound
4
Description
Maximum thickness of bulbouspongesios
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
measured by two-dimensional ultrasound
5
Description
Area of Ischiocavernus
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
measured by two-dimensional ultrasound
6
Description
Area of bulbouspongesios
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
measured by two-dimensional ultrasound
7
Description
Maximum cavernosal systolic velocity
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
measured by color ultrasound
8
Description
Minimum diastolic velocity of cavernosal artery
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
measured by color ultrasound
9
Description
Cavernosal artery diameter
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
measured by color ultrasound
10
Description
Maximum blood velocity in the posterior vein
Timepoint
Outcome will be measured at both the beginning and end of treatment
Method of measurement
measured by color ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1: Adenectomy surgery patients who will undergo manual therapy and exercise therapy. In these patients, the muscles of the ischiocaverenus and bulbospangius are released by massage. The therapist performs this technique with his index finger. The massage is performed for ten minutes. Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.
Category
Rehabilitation
2
Description
Intervention group: Intervention group 2: Radical surgery patients who will undergo manual therapy and exercise therapy. In these patients, the muscles of the ischiocaverenus and bulbospangius are released by massage. The therapist performs this technique with his index finger. The massage is performed for ten minutes. Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.
Category
Rehabilitation
3
Description
Control group: Control group1 : Adenectomy surgery patients who will undergo exercise therapy. Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.
Category
Rehabilitation
4
Description
Control group: Control group1 : Radical surgery patients who will undergo exercise therapy. Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahdi Afshar Safavi
Street address
Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798711
Phone
+98 910 500 1656
Email
mahdi3068@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farshad Okhovatian
Street address
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences , In front of Bu Ali Hospital, Imam Hossein Square , tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 912 327 7524
Email
farshadokhovatian1965@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdi Afshar Safavi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
no 11/1 . pejman 1 , ebadi 47 , mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798711
Phone
+98 51 3225 7030
Fax
Email
mahdi3068@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdi Afshar Safavi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
no 11/1 , pejman 1 , ebadi 47 . mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798711
Phone
+98 51 3225 7030
Fax
Email
mahdi3068@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdi Afshar Safavi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
no 11/1 , pejman 1 , ebadi 47 , mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798711
Phone
+98 51 3225 7030
Fax
Email
mahdi3068@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared after people are not identified and the article is published.
When the data will become available and for how long
The access period will start 2 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no specific condition
From where data/document is obtainable
Dr. Mehdi Afshar Safavi
Phone number +989105001656
No. 11/1 , Pejman 1 , Ebadi 47, Mashhad,
What processes are involved for a request to access data/document
The applicant can submit his application via email.
mahdi3068@gmail.com