Protocol summary

Study aim
To determine whether biofeedback-based PFMT prior or after radical prostatectomy could result in early achievement of continence.
Design
In this single- blinded randomized control trial with control group, 58 subjects enrolled in the study. patients randomized in to three groups. In the two case groups, biofeedback will perform before or after surgery.
Settings and conduct
All patients with the definitive diagnosis of prostate cancer who are referred to Shohada-e-Tajrish Hospital will enroll in the study. In this single blinded study, patients will be blinded by using functional biofeedback probe in the case groups whereas the control group receives nonfunctional probes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with prostate cancer confirmed by TRUSBx who are eligible for radical prostatectomy Exclusion criteria: patients who were diagnosed with prostate cancer following Transurethral Resection of Prostate, patients who received pelvic radiotherapy regardless of their primary malignancy, spinal cord injury, comorbidities that can affect urinary continence , history of pelvic or retroperitoneal surgery, neurologic disorders.
Intervention groups
In the first group, biofeedback was performed for pelvic floor muscles by a physiatrist for the duration of 30 minutes, 2 times a week for a duration of 2 weeks prior to surgery. In the second group no intervention carried out before surgery, but after removing Foley catheter, patients underwent pelvic muscle biofeedback by a physiatrist for a duration of 30 minutes, 2 times a week for 2 weeks. And finally in the third group, probe without any function will plaaaced on patients' perineum.
Main outcome variables
biofeedback before radical prostatectomy on urinary incontinence after surgery according to King's Health Questionnaire before surgery and in 1,3 and 6 months after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200429047243N1
Registration date: 2020-05-05, 1399/02/16
Registration timing: retrospective

Last update: 2020-05-05, 1399/02/16
Update count: 0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
saeed montazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8006
Email address
saeed.montazeri89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-04-20, 1399/02/01
Trial completion date
2020-07-22, 1399/05/01
Scientific title
Comparison the Effect of Pelvic Floor Muscle Biofeedback prior or post Radical Prostatectomy on Urinary Incontinence: A Randomized Clinical Trial
Public title
Comparison the Effect of Pelvic Floor Muscle Biofeedback prior or post Radical Prostatectomy on Urinary Incontinence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men with prostate cancer confirmed with TRUSBx who are candidates for radical prostatectomy
Exclusion criteria:
patients who were diagnosed with prostate cancer following Transurethral Resection of Prostate patients who received pelvic radiotherapy regardless of their primary malignancy spinal cord injury comorbidities that can affect urinary continence (such as: diabetes mellitus, overactive bladder, urethral stricture, etc.) history of pelvic or retroperitoneal surgery neurologic disorders (e.g.: Multiple Sclerosis, seizures, etc.)
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Actual sample size reached: 58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized in to three groups by a randomization software and then sealed envelope. simple randomization and individual randomization applied. Sequentially numbered, sealed, opaque envelopes will use for allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single blinded study, patients will be blinded by using functional biofeedback probe in the case groups whereas the control group receives nonfunctional probes.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
urology and nephrology research center
Street address
pasdaran street, boustan 9th, between eslami and paydarfard street
City
tehran
Province
Tehran
Postal code
1666677951
Approval date
2018-08-11, 1397/05/20
Ethics committee reference number
IR.sbmu.unrc.rec.1397.20

Health conditions studied

1

Description of health condition studied
Neuromuscular dysfunction of bladder, unspecified
ICD-10 code
N31.9
ICD-10 code description
Neuromuscular dysfunction of bladder, unspecified , prostate cancer

Primary outcomes

1

Description
biofeedback before radical prostatectomy on urinary incontinence after surgery according to King's Health Questionnaire
Timepoint
before surgery and 1,3 and 6 months after surgery
Method of measurement
King's Health Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: biofeedback prior to radical prostatectomy
Category
Rehabilitation

2

Description
Intervention group: biofeedback after radical prostatectomy
Category
Rehabilitation

3

Description
Control group: no biofeedback
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye tajrish hospital
Full name of responsible person
Saeed Monntazeri
Street address
Tehran Province, Tehran, District 1, tajrish square, shohadaye tajrish hospital
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8006
Fax
+98 21 2271 9014
Email
saeed.montazeri89@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Tehran Province, Tehran, Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
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
Saeed Montazeri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Tehran- tajrish- shohadaye tajrish hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8006
Fax
+98 21 2271 9014
Email
saeed.montazeri89@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Montazeri
Position
urology resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Tehran Province, Tehran, District 1, Tajrish square, shohadaye tajrish hospital
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8006
Fax
+98 21 2271 9014
Email
saeed.montazeri89@gmail.com
Web page address
http://shmc.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Montazeri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Tehran- tajrish- shohadaye tajrish hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8006
Fax
+98 21 2271 9014
Email
saeed.montazeri89@gmail.com
Web page address
http://shmc.sbmu.ac.ir/

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
only a fraction of data consisting of primary outcome will be shared.
When the data will become available and for how long
data will become available three months after publication.
To whom data/document is available
only people working in academic institutions will have access to these data.
Under which criteria data/document could be used
further statistical analysis on the data is permitted.
From where data/document is obtainable
applicants can contact us on E-mial: saeed. montazeri89@gmail.com
What processes are involved for a request to access data/document
After consultation with other researchers, decision will be made for data sharing. this procedure should not take more than two months.
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