The effect of pelvic floor muscle exercises (Kegel training) on improving patient’s quality of life and urinary incontinence after radical prostatectomy
The primary purpose of this project is to determine the effect of pelvic floor muscle training on improving the quality of life and urinary incontinence of the patients after radical prostatectomy.
Design
This clinical trial has a sample size of 80 individuals, randomized using random allocation software, is without a control group, community-based, and pragmatic, with parallel groups and double-blind.
Settings and conduct
Participants are selected after evaluating inclusion and exclusion criteria and assigned randomly to the control group or the Kegel training recipient group. After obtaining the demographic information of the patients, a physiotherapist will provide the necessary lessons to the intervention group during a one-hour session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 50 and 75 years old; being a candidate for prostatectomy surgery; informed consent for participation in the study.
Exclusion criteria: presence of Diabetes mellitus; neurological deficits; psychological deficits; having severe urinary incontinence prior to the surgical intervention.
Intervention groups
The intervention group is provided with training lessons for strengthening pelvic floor muscles using a biofeedback technique and are given a home exercise program. For one month each day, they will do the exercises at home. The control group does not receive pelvic floor muscle training lessons. Then, both groups of patients undergo radical prostatectomy and the intervention group continues the training for 6 months.
Main outcome variables
Quality of life and postoperative urinary incontinence status based on the questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170716035104N3
Registration date:2019-04-22, 1398/02/02
Registration timing:retrospective
Last update:2019-04-22, 1398/02/02
Update count:0
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
Roham Nik Khah
Name of organization / entity
Medical University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 6444
Email address
admin.ycc@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
2016-06-30, 1395/04/10
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
2018-03-11, 1396/12/20
Scientific title
The effect of pelvic floor muscle exercises (Kegel training) on improving patient’s quality of life and urinary incontinence after radical prostatectomy
Public title
The effect of Kegel training on quality of life and urinary incontinence after radical prostatectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 50 and 75 years old
Being a candidate for prostatectomy surgery
Informed consent for participation in the study
Exclusion criteria:
Presence of Diabetes mellitus
Neurological deficits
Psychological deficits
Having severe urinary incontinence prior to the surgical intervention
Age over 75 years due to the high prevalence of geriatric incontinence and severe pelvic floor muscle breakdown
Unavailability of the patient or the inability to follow the patient
Patient's death after surgery
Admission to ICU due to grade 3 and 4 post-operative complications
Age
From 50 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using "Simple Random Sampling" method and random value creation between zero and one in SPSS software. To allocate random values to the intervention group or control group a value less than or equal to 0.5 is assigned to the control group and values greater than 0.5 are assigned to the intervention group by sortition.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be informed about the group they are dedicated to (intervention or control). Moreover, clinical caregivers will not be informed about the patient's group (intervention or control). Researcher and the outcome evaluators will not be blinde due to the necessity for patient follow-up.
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
Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-06-03, 1396/03/13
Ethics committee reference number
IR.MUI.REC.396.926
Health conditions studied
1
Description of health condition studied
Prostate cancer
ICD-10 code
C79.1
ICD-10 code description
Secondary malignant neoplasm of bladder and other and unspecified urinary organs
Primary outcomes
1
Description
International Consultation on Incontinence Questionnaire. Male Lower Urinary Tract Symptoms long form questionnaire scores
Timepoint
One day, one week, one month, three months and six months after the surgery
Method of measurement
Evaluating the questionnaire scores
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group receives lessons on Kegel training with the biofeedback technique by a physiotherapist during a one-hour training session, and they are also given a home exercise schedule. For one month, these patients will do the exercises at home each day. Patients undergo radical prostatectomy, and standardized postoperative approaches will be considered for them until discharge. Then the control group will continue these exercises within six months (after the removal of their urinary catheter the day after the operation until the sixth month after the removal of their catheter).
Category
Rehabilitation
2
Description
The control group would undergo radical prostatectomy, and standardized postoperative approaches will be considered for them until discharge, but they receive no intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor hospital
Full name of responsible person
Mohammad Hatef Khorrami
Street address
Noor hospital, Ostandary Ave., Hasht Behesht Blvd., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8155684845
Phone
+98 31 3220 8081
Email
Shekayat.nour@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
The data of the participants, which includes demographic data and the primary outcome variables of the study, exists in data files that can be shared after individuals were unidentified.
When the data will become available and for how long
Data will be available from March 2021.
To whom data/document is available
Researchers working in universities or scientific institutions
Under which criteria data/document could be used
The data will be available for more advanced statistical analysis and review with the official permission of the Vice-Chancellor of Research of Isfahan University of Medical Sciences.
From where data/document is obtainable
To obtain official permission to access the data, the applicant must refer to the Office of the Vice-Chancellor of Research of Isfahan University of Medical Sciences in Isfahan, Iran.
What processes are involved for a request to access data/document
First, the applicant will apply for access to the data by referring to the Office of the Vice-Chancellor of Research of Isfahan University of Medical Sciences. Then the request will be processed by the Vice-Chancellor of the Isfahan University of Medical Sciences and, if deemed appropriate, the applicant will be allowed access to the information. In the next step, the applicant refers to the Research Office of the University and the data will be provided to him/her. This process may take a period of one to two months.