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NCT Number: NCT06738147

Effect of Pelvic Floor Muscle Training on Balance and Fall Risk in 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

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Treatment and study plan

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.

Other names: balance exercises

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.

Primary outcomes

  1. pelvic floor muscle activity

    Time frame: 3 months

    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)

  2. antero posterior stability index

    Time frame: 3 months

    Indicator for dynamic postural stability

  3. Medio lateral stability index

    Time frame: 3 months

    Indicator for dynamic postural stability

  4. Overall stability index

    Time frame: 3 months

    Indicator for dynamic postural stability

  5. stability an sway indexes

    Time frame: 3 months

    Indicator for fall risk

Study contacts

Contact information is provided by the study sponsor or research team.

Afaf M. Mahmoud Botla

CONTACT

00201283126608

Hager M. El dien Abdel Aziz

CONTACT

[email protected]

00201067647763 ext. 00201064262623

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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