Effect of knack maneuver with or without diaphragmatic breathing on urinary tract symptoms and quality of life among patients of stress urinary incontinence
To compare the effects of knack maneuver with or without diaphragmatic breathing on urinary tract symptoms and quality of life among patients of stress urinary incontinence.
Design
It will be single blinded, parallel study groups and randomized clinical trial
Settings and conduct
The study will be held at Arif memorial teaching hospital Lahore
Participants/Inclusion and exclusion criteria
Participants which will have age 18-50 years and diagnosed with stress urinary incontinence symptoms will be added to this study while Women who are pregnant or already having previous pelvic floor training or patients taking blood pressure medications, sedatives, muscle relaxants, and diuretics and diagnosed with mental illness will excluded from this study.
Intervention groups
Group A: Group A will given knack maneuver along diaphragmatic breathing.
In group A, We will take diagnosed patients of stress urinary incontinence and will perform knack maneuver along diaphragmatic breathing.
Group B:
In group B, We will take diagnosed patients of stress urinary incontinence and will perform knack maneuver.
The training program will be 2 days per week for 4 weeks.
Main outcome variables
Urinary distress incontinence-6: The UDI 6 is a valid and reliable six points survey, use particularly to investigate symptoms associated with lower urinary tract dysfunction; Incontinence Impact Questionnaire (IIQ-7): The IIQ 7 is a seven point's questionnaire specific to UI to impact the quality of life and
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221205056713N4
Registration date:2024-08-02, 1403/05/12
Registration timing:registered_while_recruiting
Last update:2024-08-02, 1403/05/12
Update count:0
Registration date
2024-08-02, 1403/05/12
Registrant information
Name
hafiza Nida Rasheed
Name of organization / entity
Rashid Latif Medical college, Lahore
Country
Pakistan
Phone
+92 336 4535979
Email address
naddia.rasheed20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-12-10, 1403/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of knack maneuver with or without diaphragmatic breathing on urinary tract symptoms and quality of life among patients of stress urinary incontinence
Public title
Pelvic floor strengthening exercises in stress urinary incontinence patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years
Patients diagnosed with stress urinary incontinence
Exclusion criteria:
Women who are having previous pelvic floor training.
Pregnant women are excluded
Patients taking blood pressure medications, sedatives, muscle relaxants, and diuretics are excluded.
Patients with diagnosed mental illness are excluded
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly divided in two groups (group A group B) by using lottery method. Both groups will given conventional physical therapy treatment. Group A patients will be treated with the knack maneuver along diaphragmatic breathing and Group B patients will treated with the Knack maneuver. Both group will be assessed before and after the treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects in two groups will blinded from other treatment options. However they will be
instructed to report any adverse effects during trial. Data will assessed by a third person which will not known about the study so trial will be single blinded study. (as outcome assessor will be blinded)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of Rashid Latif Medical College, Lahore
Street address
Rashid Latif Medical Complex 35-KM, Ferozepur Road. Lahore.
City
Lahore
Postal code
54000
Approval date
2023-09-11, 1402/06/20
Ethics committee reference number
IRB/2023/135
Health conditions studied
1
Description of health condition studied
stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
Urinary tract symptoms
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Urinary distress incontinence-6
2
Description
Quality of life
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Incontinence Impact Questionnaire (IIQ-7)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: will given knack maneuver along diaphragmatic breathing. In group A, We will take diagnosed patients of stress urinary incontinence and we will perform knack maneuver along diaphragmatic breathing. Firstly patient will perform diaphragmatic breathing, we will command patient to slowly and deeply take breaths through the nose using the diaphragmatic with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly. During breathing, we should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm. Generally, inhale and exhale for approximately six seconds. Now the patient will perform knack maneuver. During Knack training, patients is warned not to hold their breath, pull their stomach inward, strain, or contract their legs or hip muscles. The relationship between IAP increase and PFM contraction and the situations causing IAP increase (coughing, sneezing, laughing, lifting a heavy object, pushing, and bending down, etc.).The women will asked to perform the Knack maneuver before and during situations that increase intraabdominal pressure. The training program will include 2 days per week for 4 weeks
Category
Treatment - Other
2
Description
Intervention group 2 will given knack maneuver. In group B, We will also take diagnosed patients of stress urinary incontinence and we will perform knack maneuver. During Knack training, patients is warned not to hold their breath, pull their stomach inward, strain, or contract their legs or hip muscles. The relationship between IAP increase and PFM contraction and the situations causing IAP increase (coughing, sneezing, laughing, lifting a heavy object, pushing, and bending down, etc.).The women will ask to perform the Knack maneuver before and during situations that increase intra-abdominal pressure. The training program will include 2 days per week for 4 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif memorial teaching hospital, Lahore
Full name of responsible person
Saheeqa Qamar
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Postal code
54900
Phone
+92 313 9465214
Email
saheeqaqamar.77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical college
Full name of responsible person
Hafiza Nida Rasheed
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical college
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Saheeqa Qamar
Position
Physical Therapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 313 9465214
Email
saheeqaqamar.77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Hafiza Nida Rasheed
Position
Physical Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Hafiza Nida Rasheed
Position
Physical Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@gmail.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