Clinical trial NCT06738147: Effect of Pelvic Floor Muscle Training on Balance and Fall Risk in Females With Urinary Incontinence
Official title: "Effect of Pelvic Floor Muscle Training on Postural Balance and Fall Risk in Postmenopausal Females With Urinary Incontinence"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Balance
Keywords: pelvic floor
postural balance
fall risk
urinary incontinence
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

   -

Primary outcomes:
measure: pelvic floor muscle activity
timeFrame: 3 months
measure: antero posterior stability index
timeFrame: 3 months
measure: Medio lateral stability index
timeFrame: 3 months
measure: Overall stability index
timeFrame: 3 months
measure: stability an sway indexes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
References: