Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
Primary Purpose
Urinary Incontinence, Stress
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pelvic floor muscle plus adductor strengthening
Pelvic floor muscle exercises
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring Urinary Incontinence, Pelvic Floor Exercises
Eligibility Criteria
Inclusion Criteria:
- Women aged 25-45 years of age
- Engaged in gym exercises
- Fulfilling signs and symptoms of stress 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
- Genesis fitness centere
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pelvic floor muscle plus adductor strengthening
Pelvic floor muscle exercises
Arm Description
pelvic floor muscle plus adductor strengthening
pelvic floor muscle exercises
Outcomes
Primary Outcome Measures
Urinary Distress Inventory (UDI-6)
It is 6 point scale No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4.
Add all scores and multiply by 6 then multiply by 25 for the scale score
The UDI-6 Total Score of 33.33 was determined to be the optimal cutoff for distinguishing between symptomatic and asymptomatic women.
For UDI-6 scores more than 33.33 indicate higher distress caused by urinary incontinence symptoms.
The Revised Urinary Incontinence Scale (RUIS)
It is a 5 point scale with each point contain 3 to 4option.
Possible score range of 0 - 16
A score of less than 4 indicates that the patient has no urinary incontinence
a score of 4-8 is considered mild.
a score of 9-12 is considered moderate.
a score of 13 or above is considered severe.
Secondary Outcome Measures
Full Information
NCT ID
NCT04994041
First Posted
August 5, 2021
Last Updated
August 27, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04994041
Brief Title
Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
Official Title
Comparison of Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (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
Stress incontinence is common form of urinary incontinence in females. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening.
Detailed Description
Stress incontinence is common form of urinary incontinence in females. When it develops in gym doing women, 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 plus adductor is strengthening. Group B: with pelvic floor muscle strengthening. The collected data will be entered in Statistical Package for the Social Sciences 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, Stress
Keywords
Urinary Incontinence, Pelvic Floor Exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelvic floor muscle plus adductor strengthening
Arm Type
Experimental
Arm Description
pelvic floor muscle plus adductor strengthening
Arm Title
Pelvic floor muscle exercises
Arm Type
Active Comparator
Arm Description
pelvic floor muscle exercises
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle plus adductor strengthening
Intervention Description
20 sessions of pelvic floor muscle strengthening plus adductor is strengthening
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle exercises
Intervention Description
20 sessions of pelvic floor muscle strengthening
Primary Outcome Measure Information:
Title
Urinary Distress Inventory (UDI-6)
Description
It is 6 point scale No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4.
Add all scores and multiply by 6 then multiply by 25 for the scale score
The UDI-6 Total Score of 33.33 was determined to be the optimal cutoff for distinguishing between symptomatic and asymptomatic women.
For UDI-6 scores more than 33.33 indicate higher distress caused by urinary incontinence symptoms.
Time Frame
8 weeks
Title
The Revised Urinary Incontinence Scale (RUIS)
Description
It is a 5 point scale with each point contain 3 to 4option.
Possible score range of 0 - 16
A score of less than 4 indicates that the patient has no urinary incontinence
a score of 4-8 is considered mild.
a score of 9-12 is considered moderate.
a score of 13 or above is considered severe.
Time Frame
8 weeks
10. Eligibility
Sex
Female
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
Engaged in gym exercises
Fulfilling signs and symptoms of stress 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
Muhammad Sanaullah, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis fitness centere
City
Gujranwala
State/Province
Punjab
ZIP/Postal Code
52250
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
PubMed Identifier
28977091
Citation
Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
Results Reference
background
PubMed Identifier
28673060
Citation
Pizzoferrato AC, Fauconnier A, Fritel X, Bader G, Dompeyre P. Urethral Closure Pressure at Stress: A Predictive Measure for the Diagnosis and Severity of Urinary Incontinence in Women. Int Neurourol J. 2017 Jun;21(2):121-127. doi: 10.5213/inj.1732686.343. Epub 2017 Jun 21.
Results Reference
background
PubMed Identifier
29552736
Citation
de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.
Results Reference
background
PubMed Identifier
30193294
Citation
Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766.
Results Reference
background
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Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
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