Abdominal Muscles Strengthening And Pelvic Floor Muscle Strengthening Exercises In Females With Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
abdominal strengthening exercises
pelvic floor muscles strengthening exercises
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring bladder neck mobility
Eligibility Criteria
Inclusion Criteria:
- Women aged 25-45 years of age
- Females with abdominal muscles weakness
- Females with pelvic floor muscles weakness
- Females with urinary incontinence
Exclusion Criteria:
- Pregnant females
- Females having any history of trauma
- Any neurological disorders affecting bowl bladder
- Any malignancy in lower abdominal area
Sites / Locations
- Jinah Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
pelvic floor muscles strengthening exercises
abdominal strengthening exercises
Arm Description
pelvic floor muscles strengthening exercises
abdominal strengthening exercises
Outcomes
Primary Outcome Measures
urinary distress
Urinary Distress Inventory, Short Form (UDI-6), UDI-6 consists of 6 items: 1-Frequent urination, 2-Leakage related to feeling of urgency, 3-Leakage related to activity, 4-Coughing, or sneezing small amounts of leakage (drops), 5-Difficulty emptying the bladder, and 6-Pain or discomfort in the lower abdominal or genital area
Cough stress test
Cough stress test to evaluate urinary incontinence. Leakage of fluid from the urethral meatus coincident with/simultaneous to the cough(s) is considered a positive test.
Vaginal Ultrasonography
Bladder neck mobility can be described as a semicircular movement with the tip of the symphysis pubis as the center and a line from the tip to the bladder neck as the radius (BS). Movement can be measured by 2 independent factors: BS distance and size of the angle between the BS line and the midline of the symphysis, at rest, during the Valsalva maneuver and withholding urine. The continent controls were characterized by a 90 degrees angle at rest, a long BS (2.4 cm) and a fixed bladder neck
Secondary Outcome Measures
Full Information
NCT ID
NCT05463172
First Posted
April 15, 2022
Last Updated
December 7, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05463172
Brief Title
Abdominal Muscles Strengthening And Pelvic Floor Muscle Strengthening Exercises In Females With Urinary Incontinence
Official Title
Comparison Of Abdominal Muscles Strengthening And Pelvic Floor Muscle Strengthening Exercises On Bladder Neck Mobility In Females With Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Urinary incontinence is common females., it badly affects their performance and result in psychosocial problems in addition to the barriers that already have been resulted from incontinence. This study combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. If this comes out to be effective, this can be great contribution to gym doing females to improve their urinary incontinence related impairments. Woman would be encouraged to continue regular exercise. This will be randomized clinical trial. There are two groups for the compression of adductors strengthening and pelvic floor muscle strengthening.
The collected data will be entered in SPSS 20.0, Descriptive and Inferential statists will be applied. Results and conclusion will be drawn.
Detailed Description
Urinary incontinence is common females., it badly affects their performance and result in psychosocial problems in addition to the barriers that already have been resulted from incontinence. This study combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. If this comes out to be effective, this can be great contribution to gym doing females to improve their urinary incontinence related impairments. Woman would be encouraged to continue regular exercise. This will be randomized clinical trial. There are two groups for the compression of adductors strengthening and pelvic floor muscle strengthening.
Group A: with pelvic floor muscle strengthening is strengthening. Group B: abdominal muscles strengthening exercises. The collected data will be entered in SPSS 20.0, Descriptive and Inferential statists will be applied. Results and conclusion will be drawn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
bladder neck mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pelvic floor muscles strengthening exercises
Arm Type
Experimental
Arm Description
pelvic floor muscles strengthening exercises
Arm Title
abdominal strengthening exercises
Arm Type
Experimental
Arm Description
abdominal strengthening exercises
Intervention Type
Other
Intervention Name(s)
abdominal strengthening exercises
Intervention Description
abdominal strengthening exercises
Intervention Type
Other
Intervention Name(s)
pelvic floor muscles strengthening exercises
Intervention Description
to strengthen pelvic floor muscles
Primary Outcome Measure Information:
Title
urinary distress
Description
Urinary Distress Inventory, Short Form (UDI-6), UDI-6 consists of 6 items: 1-Frequent urination, 2-Leakage related to feeling of urgency, 3-Leakage related to activity, 4-Coughing, or sneezing small amounts of leakage (drops), 5-Difficulty emptying the bladder, and 6-Pain or discomfort in the lower abdominal or genital area
Time Frame
6 months
Title
Cough stress test
Description
Cough stress test to evaluate urinary incontinence. Leakage of fluid from the urethral meatus coincident with/simultaneous to the cough(s) is considered a positive test.
Time Frame
6 months
Title
Vaginal Ultrasonography
Description
Bladder neck mobility can be described as a semicircular movement with the tip of the symphysis pubis as the center and a line from the tip to the bladder neck as the radius (BS). Movement can be measured by 2 independent factors: BS distance and size of the angle between the BS line and the midline of the symphysis, at rest, during the Valsalva maneuver and withholding urine. The continent controls were characterized by a 90 degrees angle at rest, a long BS (2.4 cm) and a fixed bladder neck
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female only
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 25-45 years of age
Females with abdominal muscles weakness
Females with pelvic floor muscles weakness
Females with urinary incontinence
Exclusion Criteria:
Pregnant females
Females having any history of trauma
Any neurological disorders affecting bowl bladder
Any malignancy in lower abdominal area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rabiya Noor, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinah Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26811114
Citation
Schneeweiss J, Koch M, Umek W. The human urinary microbiome and how it relates to urogynecology. Int Urogynecol J. 2016 Sep;27(9):1307-12. doi: 10.1007/s00192-016-2944-5. Epub 2016 Jan 25.
Results Reference
background
PubMed Identifier
27720862
Citation
Al-Mukhtar Othman J, Akervall S, Milsom I, Gyhagen M. Urinary incontinence in nulliparous women aged 25-64 years: a national survey. Am J Obstet Gynecol. 2017 Feb;216(2):149.e1-149.e11. doi: 10.1016/j.ajog.2016.09.104. Epub 2016 Oct 6.
Results Reference
background
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Abdominal Muscles Strengthening And Pelvic Floor Muscle Strengthening Exercises In Females With Urinary Incontinence
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