The purpose of the study is to evaluate the effects pelvic floor muscle training with biofeedback therapy for urinary incontinence.
The purpose of the study is to evaluate the effects pelvic floor muscle training without biofeedback therapy for urinary incontinence.
Design
A prospective comparative randomized controlled trial (RCT)
Settings and conduct
To study the difference between improvement in symptoms and quality of life of patient receiving pelvic floor muscle training with and without biofeedback therapy for urinary incontinence, a randomized controlled trial will conduct in Memon Medical Institute Hospital Karachi Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Patient who are willing to participate in the study.
Menopausal women.
Pre and post-menopause.
Urinary incontinence with the effort.
Age limit is 19-50 years
Exclusion Criteria
Experiencing psychotic symptoms at baseline
Females with neurological conditions that affect sphincteric function or colorectal, pelvic, gynecological or genitourinary.
Surgery or malignancy where the exciting pathology interferes with the prescribed pelvic floor muscle training program will exclude.
Biofeedback-assisted pelvic floor muscle training were not suitable will also exclude
Intervention groups
We will use biofeedback therapy machine for pelvic floor muscles training
Main outcome variables
The kings health questionnaire,
Pelvic floor Impact questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220804055615N2
Registration date:2022-12-08, 1401/09/17
Registration timing:retrospective
Last update:2022-12-08, 1401/09/17
Update count:0
Registration date
2022-12-08, 1401/09/17
Registrant information
Name
Mohabbat Ali
Name of organization / entity
Memon Medical Intitute Hospital
Country
Pakistan
Phone
+92 21 99261810
Email address
ramal_209@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-01, 1401/07/09
Expected recruitment end date
2022-10-30, 1401/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of pelvic floor muscle training with or without biofeedback therapy for urinary incontinence
Public title
Effectiveness of pelvic floor muscle training with or without biofeedback therapy for urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who are willing to participate in the study.
Menopausal women
Pre and post-menopause
Urinary incontinence with the effort
Age limit is 19-50 years
Exclusion criteria:
Experiencing psychotic symptoms at baseline
Females with neurological conditions that affect sphincteric function or colorectal, pelvic, gynecological or genitourinary
Surgery or malignancy where the exciting pathology interferes with the prescribed pelvic floor muscle training program will exclude
Biofeedback-assisted pelvic floor muscle training were not suitable will also exclude
Age
From 19 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Patients refereed from Gynecology out patient department. We will maintain a excel sheet on computer every odd number will consider in controlled group and even number in conventional group.
We will use biofeedback therapy machine for controlled group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients with the complain of urinary incontinence filled the concern form for study but not inform regarding two different groups, distributed the patients with odd and even numbers in two groups.
Placebo
Not used
Assignment
Parallel
Other design features
4
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Intitutional Review Board Memon Medical Institute Hospital
Street address
Safoora Goth Scheme 33
City
Karachi
Postal code
75270
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IRB/MMIH/2022/12
Health conditions studied
1
Description of health condition studied
pelvic floor muscles weakness
ICD-10 code
N39.46
ICD-10 code description
Mixed incontinence
Primary outcomes
1
Description
Pelvic floor muscles weakness
Timepoint
3 month
Method of measurement
Muscle will measure by biofeedback therapy
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group participants will be treated with bio feed back therapy followed by pelvic floor exercises. bio feed back therapy(exercises) 30 minutes session done with a machine of enraf nonius with brand name of myomed. In inventional group there will be no intervention of any chemical. Total sessions of exercises will be 12 and 3 session in a week. duration of study is 3 month
Category
Rehabilitation
2
Description
Controlled group will treated with conventional pelvic floor exercises only
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Memon Medical Institute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Street address
Safoora Goth
City
Karachi
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34691193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Memon Medical Intitute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Street address
Safoora Goth
City
Karachi
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34691193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Grant name
Institute budget
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Memon Medical Intitute Hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Memon Medical Instute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Safoora Goth
City
karachi
Province
Sindh
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34691193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Memon Medical Institute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Safoora goth
City
Karachi
Province
Sindh
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34691193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Memon Medical Institute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Safoora
City
Karachi
Province
Sindh
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34861193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effectiveness of Pelvic floor muscles training with or without biofeedback therapy for urinary incontinence
When the data will become available and for how long
With in 3 three month
To whom data/document is available
Data will be available only who are working in the out patient department
Under which criteria data/document could be used
Data not allowed to others
From where data/document is obtainable
Out patients department
What processes are involved for a request to access data/document
Not allowed to any other researchers
Comments
This is gynecology and physiotherapy department research