- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06835309
Isokinetic Strengthening of Hip Muscles Effect on Pelvic Floor Muscles Function in Females With SUI (SUI)
February 17, 2025 updated by: British University In Egypt
Implications of Isokinetic Strengthening of Hip Muscles on Pelvic Floor Muscles Function in Women Experiencing Stress Urinary Incontinence
This study will be conducted to investigate the impact of isokinetic strengthening of hip muscles on pelvic floor muscles function in women experiencing stress urinary incontinence Does isokinetic strengthening of hip muscles impact pelvic floor muscles function in women experiencing stress urinary incontinence?
Study Overview
Status
Enrolling by invitation
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt, 4914058
- British University In Egypt
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients diagnosed with stress urinary incontinence
- age between 30 and 50 years
Exclusion Criteria:
- low back pain
- lower limb muscle pathology and/or joint degeneration
- cardiovascular, metabolic or pulmonary disease
- body mass index (BMI) > 30 kg/m2.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control arm
Pelvic floor muscles exercises
|
The exercises for strengthening the PFM were 10 contractions of 5 seconds, 15 contractions of 3 seconds, 20 contractions of 2 seconds, 20 contractions of 1 second (equal rest time between contractions), and 5 repetitions of maximum contractions while coughing (1-minute interval).25
The level of difficulty of the exercises throughout the 20 sessions was determined by the patient's position, starting in a supine position, then progressing to a sitting position and, finally, to a standing position
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Experimental: Treatment arm
Pelvic floor muscles exercises and isokinetic strengthening of hip muscles
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The hip muscle strengthening exercise was executed on Biodex multi-joint system isokinetic dynamometer.
Muscle tension of the lower limbs was relieved by executing 5-minute warm-up exercises using a cycle ergometer before execution of the isokinetic exercise For each hip muscle group, eight repetitions per set for 4 sets were carried out for a single exercise with a 30 second break between each set.
The patient's position were the same positions used in the testing procedure.
The exercises were carried out 3 times a week and the hip muscles strength evaluation was conducted after the end of the program intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic floor muscle strength
Time Frame: 12 weeks
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Perineometry to measure vaginal squeeze pressure (in mm hg) the more the grade, the better the muscle strength and so the less the stress urinary incontinence
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress urinary incontinence.
Time Frame: 12 weeks
|
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) to evaluate the frequency, severity and impact on quality of life) the less the grade, the better the muscle strength and so the less the stress urinary incontinence
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2025
Primary Completion (Estimated)
April 23, 2025
Study Completion (Estimated)
May 23, 2025
Study Registration Dates
First Submitted
January 23, 2025
First Submitted That Met QC Criteria
February 17, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 17, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
Other Study ID Numbers
- P.T.REC/012/005601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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