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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence; Balance
• Intervention / Treatment: Other: pelvic floor muscle training; Other: balance exercises

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hager M. El dien Abdel Aziz; Phone Number: 00201064262623 00201067647763; Email: hager.mohey@deraya.edu.eg
• Study Contact Backup: Name: Afaf M. Mahmoud Botla; Phone Number: 00201283126608

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 12613
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: balance exercises; 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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: urinary incontinence; postural balance; pelvic floor; fall risk
• 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
• Other Study ID Numbers: P.T.REC/012/005377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No