The effect of pelvic floor muscle training with and without biofeedback and electrical stimulation on urinary incontinence and quality of life in postmenopausal women: A clinical trial
Determining the effect of pelvic floor exercises with and without biofeedback and electrical stimulation on urinary incontinence and quality of life in postmenopausal women
Design
A controlled, parallel-group, non-randomized, not blinded clinical trial on 60 postmenopausal women.
Settings and conduct
This is an interventional study with two groups of 30 postmenopausal women aged 45 to 60 years who suffer from urinary incontinence. For the pelvic floor exercises group, the necessary training will be given in the first session and for the electrical stimulation and biofeedback group, in addition to pelvic floor exercises, 8 physiotherapy sessions will be conducted at one-week intervals. The outcome of interest is urinary incontinence and quality of life
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 45-60 years, one year since the last menstrual period after the onset of natural menopause, not taking urinary incontinence medications, residing in Tabriz city. Exclusion criteria: Mental and motor disability, history of any physical or mental illness that causes urinary incontinence.
Intervention groups
For the pelvic floor exercises group, the necessary training will be given in the first session in a private room, and the researcher will make phone calls to the participants of this group every week for 8 weeks to follow up and provide the necessary training. For the electrical stimulation and biofeedback group, in addition to pelvic floor exercises, 8 physiotherapy sessions will be conducted at one-week intervals, and before each session, the time of the intervention will be reminded.
Main outcome variables
Urinary Incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111219008459N18
Registration date:2025-04-26, 1404/02/06
Registration timing:prospective
Last update:2025-04-26, 1404/02/06
Update count:0
Registration date
2025-04-26, 1404/02/06
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pelvic floor muscle training with and without biofeedback and electrical stimulation on urinary incontinence and quality of life in postmenopausal women: A clinical trial
Public title
The effect of pelvic floor muscle training with and without of biofeedback and electrical stimulation on urinary incontinence and quality of life in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45-60 years
One year has passed since the last menstrual period after the onset of natural menopause.
Not taking urinary incontinence medications
Resident of Tabriz city
Exclusion criteria:
Mental and motor disability
History of any physical or mental illness that causes urinary incontinence
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of Tabriz University of Medical Sciences
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2025-04-16, 1404/01/27
Ethics committee reference number
IR.TBZMED.REC.1404.020
Health conditions studied
1
Description of health condition studied
Urinary incontinence and quality of life in postmenopausal women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Urinary Incontinence
Timepoint
8 weeks after intervention
Method of measurement
Using of Incontinence Questionnaire-Urinary Incontinence Short Form: ICIQ-UISF
Secondary outcomes
1
Description
Life Quality
Timepoint
8 weeks after intervention
Method of measurement
Using of Incontinence Quality of Life Questionnaire: I- QoL
Intervention groups
1
Description
Intervention group: In addition to pelvic floor exercise training, women in this group (30 postmenopausal women with urinary incontinence) will receive biofeedback and electrical pelvic floor stimulation over 8 sessions, one week apart.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital of Tabriz
Full name of responsible person
Shirin Hasanpour
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3382 3660
Email
shirinhasanpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosrow Adibkia
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD