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

NCT06738147 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005377
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Balance

Keywords

pelvic floor; postural balance; fall risk; urinary incontinence

Outcome Measures

Primary Outcomes (5)

• pelvic floor muscle activity

  Assessment of pelvic floor muscle by Ultrasound imaging device, it will be used to assess PFM activity by measuring bladder base displacement (as a marker for PFM activity)

  3 months

• antero posterior stability index

  Indicator for dynamic postural stability

  3 months

• Medio lateral stability index

  Indicator for dynamic postural stability

  3 months

• Overall stability index

  Indicator for dynamic postural stability

  3 months

• stability an sway indexes

  Indicator for fall risk

  3 months

Study Arms (2)

Experimental Group (A)

EXPERIMENTAL

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.

Other: pelvic floor muscle training; Other: balance exercises

Control Group (B)

OTHER

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.

Other: balance exercises

Interventions

pelvic floor muscle training 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.

Also known as: balance exercises

Experimental Group (A)

balance exercises 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); Experimental Group (A)

Eligibility Criteria

• Age: 50 Years - 60 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• History of lower extremity injury, surgery or pain during ADL.
• Females having any vestibular problems, otitis media, labyrinthitis or any inner ear problems that affect balance.
• Women with mild, moderate and severe cognitive deficits.
• Women with neurological diseases, including conditions after a Stroke.
• Females with a history of brain injury.
• Females with significant visual and hearing damage confirmed by neurological examination.
• Females with serious internal orthopedic and oncological diseases.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hager M. El dien Abdel Aziz

CONTACT

00201067647763; hager.mohey@deraya.edu.eg

Afaf M. Mahmoud Botla

CONTACT

00201283126608

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of physical therapy for woman health at deraya university

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 17, 2024
• Study Start: December 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)