Effect of Pelvic Floor Muscle Training on Balance and Fall Risk in Females With Urinary Incontinence

NCT ID: NCT06738147

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-02-28

Brief Summary

Understanding the relationship between Pelvic floor muscle dysfunctions as stress urinary incontinence with Postural balance ability and subsequent fall risk in postmenopausal females is important in terms of injury prevention and decrease morbidity and mortality rate among postmenopausal females. Therefore, this study investigating the effect of pelvic floor muscle training on postural balance and fall risk in postmenopausal females with stress urinary incontinence.

Detailed Description

Thirty post-menopausal females will participate in this study. They will be selected from the outpatient clinic at Daraya University.They will be randomly assigned in two groups experimental (A) and control (B) group, each group will have (15) postmenopausal female. Experimental Group (A):

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by pelvic floor muscle training (PFMT) for 30 min., 3 sessions/ week in addition to traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

Control Group (B):

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by traditional physical and balance training program only (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

All females in both groups will be evaluated for urinary incontinence through ultrasonography and pelvic floor bother questionnaire (PFBQ) at the beginning of the study and at the end of treatment period. Also, static, and dynamic balance performance and fall risk will be assessed in the beginning of the study and at the end of treatment period through the Biodex balance system and Tinetti Performance Oriented Mobility Assessment (POMA). All participants will be given an explanation of study protocol, and an informed consent form will be signed by each female

Conditions

Urinary Incontinence; Balance

Keywords

pelvic floor; postural balance; fall risk; urinary incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental Group (A)

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by pelvic floor muscle training (PFMT) for 30 min., 3 sessions/ week in addition to traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

Group Type: EXPERIMENTAL

pelvic floor muscle training

Intervention Type: OTHER

pelvic floor muscle training (PFMT) for 30 min., 3 sessions/ week in addition to traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

balance exercises

Intervention Type: OTHER

traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

Control Group (B)

It will consist of (15) postmenopausal females are complaining of urinary incontinence and balance disturbances who will be treated by traditional physical and balance training program only (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

Group Type: OTHER

balance exercises

Intervention Type: OTHER

traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

Interventions

pelvic floor muscle training

pelvic floor muscle training (PFMT) for 30 min., 3 sessions/ week in addition to traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

Intervention Type: OTHER

balance exercises

traditional physical and balance training program (proprioception training and balance exercises for the static and dynamic components of balance for 30 min., three sessions/ week for six weeks.

Intervention Type: OTHER

Other Intervention Names

balance exercises

Eligibility Criteria

Inclusion Criteria

• 1. All females will be postmenopausal. 2. Their ages will range from: 50-60 years. 3. Their BMI will be less than 30 kg\m2. 4. All females will be suffering from urinary incontinence. 5. All females will be sedentary. 6. All females will have balance disorders. 7.All females will be able to walk across a small room without an assistive device.

Exclusion Criteria

1. History of lower extremity injury, surgery or pain during ADL.

2. Females having any vestibular problems, otitis media, labyrinthitis or any inner ear problems that affect balance.

3. Women with mild, moderate and severe cognitive deficits.

4. Women with neurological diseases, including conditions after a Stroke.

5. Females with a history of brain injury.

6. Females with significant visual and hearing damage confirmed by neurological examination.

7. Females with serious internal orthopedic and oncological diseases.

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• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hager Mohey Eldien Abdel Aziz Mahmoud

Assistant lecturer of physical therapy for woman health at deraya university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, Giza Governorate, Egypt

Countries

Egypt

Central Contacts

Hager M. El dien Abdel Aziz

Role: CONTACT

Phone: 00201067647763

Email: hager.mohey@deraya.edu.eg

Afaf M. Mahmoud Botla

Role: CONTACT

Phone: 00201283126608

Other Identifiers

P.T.REC/012/005377

Identifier Type: -

Identifier Source: org_study_id