CClinicalTrials.gg
Not yet recruitingNCT06738147Updated Dec 17, 2024

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

An interventional study of pelvic floor muscle training and balance exercises in Urinary Incontinence and Balance, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-17.

Sponsored by Cairo University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Urinary Incontinence
  • Balance

Keywords

  • pelvic floor
  • postural balance
  • fall risk
  • urinary incontinence
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 30 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.

    -

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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 · Other: balance exercises

  • 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

Interventions

  • Otherpelvic 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.

    Also known as: balance exercises

  • Otherbalance 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 months

  2. antero posterior stability index

    Indicator for dynamic postural stability

    Time frame: 3 months

  3. Medio lateral stability index

    Indicator for dynamic postural stability

    Time frame: 3 months

  4. Overall stability index

    Indicator for dynamic postural stability

    Time frame: 3 months

  5. stability an sway indexes

    Indicator for fall risk

    Time frame: 3 months

07

Study locations

1 site
  • Cairo University
    Cairo, Giza 12613, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06738147
Lead sponsor
Cairo University
Responsible party
Hager Mohey Eldien Abdel Aziz Mahmoud (Assistant lecturer of physical therapy for woman health at deraya university, Cairo University) — Principal investigator
First posted
Dec 17, 2024
Start date
Dec 2024 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
Feb 2025 (estimated)
Last update
Dec 17, 2024

Study contacts

Hager M. El dien Abdel Aziz
Contact
hager.mohey@deraya.edu.eg
00201067647763 ext. 00201064262623
Afaf M. Mahmoud Botla
Contact
00201283126608

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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