Clinical trial NCT05341778: Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence
Official title: Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary incontinence
Older females
Pelvic floor disorders
Urination
Quality of life
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
Collaborators: name: The Institute of Physical Medicine and Rehabilitation
First posted: 2022-04-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of Pilates exercises versus pelvic floor muscle exercises among elderly women with urinary incontinence. The study is a single-blinded randomized clinical trial. 70 patients(calculated through PASS version 15 software) will be selected. Subjects will be screened whether they met inclusion and exclusion criteria. The participants for this study will be elderly women with urinary incontinence. The participants will be recruited from SIPMR and Civil hospital Karachi. The initial assessment will be done by Medical Consultant. Patients must fulfill inclusion criteria. Consent must be taken from each patient and samples will be collected in the given time frame and patients will be randomly assigned(through a randomization sheet) to the treatment groups. Treatment group 1 will be doing Pilates exercises and treatment group 2 will be doing Pelvic floor muscle exercises. EMS will be given to both treatment groups. A voiding diary, Stamey's urinary incontinence system, and IQOL questionnaire will be used at baseline assessment and at the end of treatment sessions. 12 treatment sessions will be given, 3 visits each week for 4 weeks. The data will be analyzed on SPSS version 21. : Non-probability purposive sampling technique will be used for selecting individuals. Percentages and frequencies will be calculated for categorical variables and parametric and nonparametric tests will be applied.


Eligibility criteria: Inclusion Criteria:

* Elderly females from an outpatient setting of Sindh Institute of physical medicine and rehabilitation and civil hospital Karachi.
* Patients aged ≥60 years.
* Experienced stress or mixed urinary incontinence symptoms at least 3 times/ week for 3 months or more.

Exclusion Criteria:

* Have limited mobility (unable to move without crutches, walker, or a cane).
* Have untreated chronic constipation or have experienced any stool or mucus leakage.
* Organ prolapse surgery within the last year.
* In the last 3 months, any active urinary or vaginal infection.
* Malignancy

Primary outcomes:
measure: Change in volume of urine in millilitre on Voiding Diary after 4 weeks
timeFrame: baseline and after 4 weeks
measure: Change in intensity and frequency of urine leakage on Voiding Diary after 4 weeks
timeFrame: baseline and after 4 weeks
measure: Change in the number of pads on Voiding Diary after 4 weeks.
timeFrame: baseline and after 4 weeks
measure: Change in frequency and grading of urgency on Voiding Diary after 4 weeks
timeFrame: baseline and after 4 weeks
measure: Change in urine incontinence on Stamey's incontinence scoring system after 4 weeks
timeFrame: baseline and after 4 weeks
Secondary outcomes:
measure: Change in Quality of life on Quality of life measures questionnaire scores after 4 weeks
timeFrame: baseline and after 4 week
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Humera Ahmed
state: Sindh
Study officials:
affiliation: Sindh Institute of Physical Medicine and Rehabilitation
name: Aftab Ahmed Mirza Baig, MSAPT
role: STUDY_DIRECTOR
affiliation: Dow University of Health Sciences
name: Humera Ahmed, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation
name: Rabail Rani Soomro, MSPT
role: STUDY_DIRECTOR
References: