Protocol summary

Study aim
Comparison of the effectiveness of functional intravaginal electrical stimulation and pelvic floor and pelvic external rotator muscle strengthening exercises on urinary incontinence
Design
Clinical trial with 3 groups , with parallel groups, single -blind, randomized, on 60 patients. Sealed envelopes will be used for randomization
Settings and conduct
This study will be conducted in Isfahan city, in two rehabilitation faculty centers and in the pelvic floor clinic. The study will be conducted in a single-blind manner and the participants(patients) will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women diagnosed with stress and mixed urinary incontinence by a urologist,Average age between 30-65 years,Absence of pregnancy and a one-year postpartum period, No receive medical or surgical treatment for urinary incontinence,Absence of any urinary-genital infection,Absence of neuromuscular diseases, Absence of severe pelvic prolapse Exclusion criteria: Any problem that may interfere with the continuation of the treatment, Patient's lack of consent to continue the treatment
Intervention groups
Group 1:In this group, patients will receive feedback from the performance of the muscles while performing pelvic floor exercises using the EMG biofeedback device. Group 2:In this group, in addition to the exercises of the first group, patients will perform pelvic rotator muscle exercises. Group 3:In addition to the treatment of first group, this group will receive electrical stimulation of the pelvic floor.
Main outcome variables
Quality of life questionnaire, The number of unwanted urinations ,Pelvic floor muscle strength ,Strength of external hip rotator muscles

General information

Reason for update
Acronym
EMG
IRCT registration information
IRCT registration number: IRCT20090301001722N30
Registration date: 2023-07-11, 1402/04/20
Registration timing: prospective

Last update: 2023-07-11, 1402/04/20
Update count: 0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-30, 1402/06/08
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of pelvic floor muscle strengthening exercise, pelvic floor muscle strengthening exercise plus hip rotator muscle exercise, and pelvic floor muscle strengthening exercise plus electrical stimulation on the symptoms of women with stress and mixed urinary incontinence
Public title
Evaluation of the effects of pelvic floor muscle strengthening exercise plus hip rotator muscle exercise on the stress urinary incontinence
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Women diagnosed with stress and mixed incontinence by a urologist Average age between 30-65 years Absence of pregnancy and a one-year postpartum period No receive medical or surgical treatment for incontinence Absence of genital area disease Absence of neuromuscular diseases Absence of severe pelvic prolapse
Exclusion criteria:
Any problem that may interfere with the continuation of the treatment The patient's lack of consent to continue the treatment
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to three groups. Patients are explained in advance about being placed in one of these three treatment groups and it is understood that you will be placed in one of these three groups. Then, to observe the random assignment of patients, envelopes will be prepared containing the methods of treatment groups, and the patient will choose one of them. Accordingly, the patient will enter his treatment group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients know that they will participate in one of the treatment groups. The therapist and the assessor are blind to the grouping. It will be planned so that participants in different treatment groups do not face each other and there will be no contact between them.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Nursing and Midwifery and Faculty of Rehabilitation - Tehran University of Medical Scienc
Street address
Tehran University of Medical Sciences, Qods corner., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-06-25, 1402/04/04
Ethics committee reference number
IR.TUMS.FNM.REC.1402.061

Health conditions studied

1

Description of health condition studied
stress and mix urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female)

Primary outcomes

1

Description
Unwanted leakage of urine in one day
Timepoint
At the beginning of the study, after 6 weeks in the last session
Method of measurement
questionnaire

2

Description
Quality of life
Timepoint
At the beginning of the study, after 6 weeks in the last session
Method of measurement
questionnaire (I-QOL)

Secondary outcomes

1

Description
Pelvic floor muscle strength
Timepoint
At the beginning of the study, after 6 weeks in the last session
Method of measurement
Perineometer instrument ,Electromyography

Intervention groups

1

Description
Control group: the patients, three times a week, when performing pelvic floor exercises alongside an EMG biofeedback device, will receive feedback on the functioning of the muscles. Patients will be treated and controlled with biofeedback for 15 minutes
Category
Rehabilitation

2

Description
First intervention group: in this group, in addition to the exercises, they will perform the exercises of the pelvic external rotator muscles.
Category
Rehabilitation

3

Description
Second Intervention group: In addition to the exercises, this group will receive electrical stimulation of the pelvic floor. In this group of patients, they also be treated three times a week and along with pelvic floor exercises, intravaginal electrical stimulation is performed by a vaginal probe (50 Hz, 200 microseconds for 15 minutes).
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Anahita Torkzadeh
Street address
Faculty of Rehabilitation Sciences ,University of Medical Sciences,Hazar Jarib St
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 409 9848
Email
Anahitatkz@yahoo.com

2

Recruitment center
Name of recruitment center
Pelvic floor disorders rehabilitation center
Full name of responsible person
Anahita Torkzadeh
Street address
No 14, Hafez building , Felestin Ave
City
Esfahan
Province
Isfehan
Postal code
8143995956
Phone
+98 913 409 9848
Email
Anahitatkz@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
Tehran University of Medical Sciences, Qods corner., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Anahita Torkzadeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Pich Shamiran., Enghelab St
City
Faculty of Rehabilitation, Corner of Safi Alishah St., Pich Shamiran., Enghelab St
Province
Tehran
Postal code
1148965111
Phone
+98 21 6649 2271
Email
Anahitatkz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Hadian Rasanani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neurorehabilitation, clinical elecroneurophysiology, Locomotion
Street address
School of Rehabilitation, corner of Safi Alishah St., Pich Shamiran., Enghelab St
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
hadianrasan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anahita Torkzadeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran., Enghelab St
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 6649 2271
Email
anahitatkz@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Loading...