Evaluation of the efficacy of using the pelvic floor muscle training application in comparison with physiotherapy in patients with urinary incontinence
Determining the efficiency of using the pelvic floor muscle strengthening training application compared to physiotherapy in patients with urinary incontinence.
Design
70 patients will be placed in two groups of physiotherapy or application with parallel groups, single blinded and randomized by random allocation software.
Settings and conduct
After obtaining written informed consent from the participants, and at the Al-Zahra Hospital in Isfahan, two ICIQ- SF and ICIQ-L were administered in both groups before the intervention and 3 months later. It will be completed during an interview from the beginning of the treatment. In the physiotherapy group, 20-15 physiotherapy sessions will be prescribed. which they will undergo in khorshid physiotherapy center. In the application group, the necessary Kegel exercises are given to the patients. After completing the follow-up period of all patients, the obtained information will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18-70 years;
Female gender;
Persistence of urinary incontinence symptoms at least once a week ;
Stress incontinence or Mixed;
BMI=20-30;
POP grade 1 or 2;
- The exclusion criteria are:
Pregnancy;
Difficulty passing urine;
Macroscopic hematuria;
Patients whose urinary symptoms were diagnosed in the POP grade 3 or 4.
Intervention groups
Patients included in this study are divided into two groups intervention group use the application designed to perform the exercises and Patients in the control group will be treated with pelvic floor muscle physiotherapy for 15-20 sessions.
Main outcome variables
Study group:
Urinary frequency score (before and after treatment);
Urine leakage score (before and after treatment);
The impact score of urinary leakage on the quality of life (before and after treatment);
Quality of life score (before and after treatment).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210928052626N1
Registration date:2022-11-27, 1401/09/06
Registration timing:registered_while_recruiting
Last update:2022-11-27, 1401/09/06
Update count:0
Registration date
2022-11-27, 1401/09/06
Registrant information
Name
Maede Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 6001
Email address
safari.maede@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of using the pelvic floor muscle training application in comparison with physiotherapy in patients with urinary incontinence
Public title
Evaluation of the efficacy of using the pelvic floor muscle training application in comparison with physiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age : 18-70 y/o
Female
Urinary incontinence for at least once a week
Diagnosed stress or mixed incontinence
Vaginal prolapse grade 1 or 2
BMI=20-30
Exclusion criteria:
Difficulty urinating
Pregnancy
Macroscopic hematuria
Urinary symptoms related to grade 3 or 4 of POP
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
first the participants are grouped by degree of urinary incontinence in three groups, then the patient's names are sorted by the alphabetic order, and each of them assigned a number. Patients are randomly assigned to control and intervention groups by random allocation software in individual units. Block randomization will be used with a block size of 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
n this study, the patients and the clinical caregiver providing physiotherapy services and the person who teaches the use of the app are aware of which group they belong to. However, the researcher and the analyst do not know about the division of the patients.
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
Kharazmi 3 avenue, Sepahanshahr
City
Isfahan
Province
Isfehan
Postal code
8179975514
Approval date
2022-10-19, 1401/07/27
Ethics committee reference number
IR.MUI.MED.REC.1401.267
Health conditions studied
1
Description of health condition studied
stress or mixed urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
The score obtained in the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life
Timepoint
The beginning of the study (before the start of the intervention) and three months after its start
Method of measurement
The ICIQ-LUTS-qol questionnaire
2
Description
The score obtained in the International Consultation on Incontinence Questionnaire - Short Form
Timepoint
The beginning of the study (before the start of the intervention) and three months after its start
Method of measurement
International Consultation on Incontinence Questionnaire - Short Form questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: our designed application is used to train the intervention group with kegel exercises for three months and 30 minutes each day.
Category
Rehabilitation
2
Description
Control group: these patients are prescribed 10-15 physiotherapy sessions for pelvic floor muscle training
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and therapeutic centers of Isfahan
Full name of responsible person
Maede Safari
Street address
No. 46, Latif dead end, Shadab Ave, Weast Sharif ave, Kharazmi 3 ave, Qadir Blvd., Sepahan shahr Town
City
Isfahan
Province
Isfehan
Postal code
8179975514
Phone
+98 31 3650 7377
Email
safari.maede@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash
Street address
Isfahan University of Medical Sciences, Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
siavash@med.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
Maede Safari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services