Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Shoulder bridge; Other: Clam shell; Other: Scissors; Other: Adductor squeeze; Other: Pelvic clock supine; Device: Electrical muscle stimulation; Other: urine hold and tummy tuck in; Other: Bridging; Other: Split table top

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Humera Ahmed, DPT; Phone Number: 03352976633; Email: sweethummi12@gmail.com
• Study Contact Backup: Name: Rabail Rani Soomro, MSPT; Phone Number: 03341348099; Email: rabail.physio@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Recruiting
      • Humera Ahmed
      • Contact: Aftab Ahmed Mirza Baig, MSAPT; Phone Number: +923002739920; Email: ab.dptrm@gmail.com
      • Contact: Rabail Rani Soomro, MSPT; Phone Number: +923132054425; Email: rabail.physio@gmail.com
      • Principal Investigator: Humera Ahmed, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates exercises; The Pilates method's exercises emphasize breathing and the activation of the deep stabilizing muscles of the trunk in coordination with the PFM. The pilates method consists of exercises that emphasize pelvic stability, mobility, and body alignment. PMFE are performed in tandem with breathing, with concurrent trunk muscle recruitment in various positions.	Other: Shoulder bridge; The shoulder bridge is great for, strengthening your gluteal muscles, quadriceps, hamstrings, pelvic floor, abdominals and back muscles; most notably the tiny ones which control movement of each individual vertebrae and can weaken after episodes of back pain.; Other: Clam shell; Scissors is an abdominal exercise that strengthens the transverse abdominals, helping flatten your belly and strengthen your entire core. Scissors is not only a core strength move, but it is also a great stretch for your hamstrings and your lower back.; Other: Scissors; Scissors is an abdominal exercise that strengthens the transverse abdominals, helping flatten your belly and strengthen your entire core. Scissors is not only a core strength move, but it is also a great stretch for your hamstrings and your lower back.; Other: Adductor squeeze; Adductor Squeeze exercise The SQ exercise is an isometric hip adduction exercise with the player holding a ball between their knees.; Other: Pelvic clock supine; The pelvic clock is a brilliant exercise to help achieve flexibility and strength in the lower back, pelvic floor, and core-in order to prevent pain and injury.; Device: Electrical muscle stimulation; Electric stimulation works by mimicking the natural way by which the body exercises its muscles. The electrodes attached to the skin deliver impulses that make the muscles contract. It is beneficial in increasing the patient's range of motion and improves the circulation of the body.
Active Comparator: Pelvic floor exercise; These exercises are intended to strengthen weak perineal and pelvic floor muscles.	Other: Clam shell; Scissors is an abdominal exercise that strengthens the transverse abdominals, helping flatten your belly and strengthen your entire core. Scissors is not only a core strength move, but it is also a great stretch for your hamstrings and your lower back.; Other: Adductor squeeze; Adductor Squeeze exercise The SQ exercise is an isometric hip adduction exercise with the player holding a ball between their knees.; Device: Electrical muscle stimulation; Electric stimulation works by mimicking the natural way by which the body exercises its muscles. The electrodes attached to the skin deliver impulses that make the muscles contract. It is beneficial in increasing the patient's range of motion and improves the circulation of the body.; Other: urine hold and tummy tuck in; During tummy tuck patients are able to strategically tighten and reinforce the muscles around the pelvic floor, urethra, and other structures. This increased strength and support greatly reduces stress urinary incontinence; Other: Bridging; A bridge exercise isolates and strengthens your gluteus (butt) muscles - the gluteus maximus, medius and minimus - and hamstrings, which are the main muscles that make up the posterior chain. It is done by lying on your back with your knees bent, feet flat on the ground and at a comfortable distance from your butt.; Other: Split table top; To strengthen your abs, shoulders, arms and legs. The most important part of this move is to contract your abs fully before you start to lower your hips

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in volume of urine in millilitre on Voiding Diary after 4 weeks	It will be recorded by patient in millilitre in a marked beaker. Increase in millilitre suggests increase in volume of urine.	baseline and after 4 weeks
Change in intensity and frequency of urine leakage on Voiding Diary after 4 weeks	It will be recorded by patient with yes or no option. Increase in ticks on yes options suggests increase in intensity and frequency of urine leakage.	baseline and after 4 weeks
Change in the number of pads on Voiding Diary after 4 weeks.	It will be recorded by patient with the symbol P if yes and blank if No. Increase in written symbol P suggests increased number of pads.	baseline and after 4 weeks
Change in frequency and grading of urgency on Voiding Diary after 4 weeks	It will be recorded by patient with grades 0=little, +=mild, ++=extreme urgency. The more the score the worst the urinary incontinence is.	baseline and after 4 weeks
Change in urine incontinence on Stamey's incontinence scoring system after 4 weeks	It is based on the patient's incontinence history alone. It will be graded from 0=no incontinence to 3=total incontinece at all times.The higher the score the more severity of urinary incontinence is	baseline and after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of life on Quality of life measures questionnaire scores after 4 weeks	All the participants will complete an incontinence-related quality of life questionnaire to assess the quality of life of patients suffering from urinary incontinence.Higher the scores, the higher will be quality of life.	baseline and after 4 week

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Collaborators: The Institute of Physical Medicine and Rehabilitation
• Investigators: Study Director: Aftab Ahmed Mirza Baig, MSAPT, Sindh Institute of Physical Medicine and Rehabilitation; Principal Investigator: Humera Ahmed, DPT, Dow University of Health Sciences; Study Director: Rabail Rani Soomro, MSPT, Sindh Institute of Physical Medicine and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Urinary incontinence; Pelvic floor disorders; Older females; Urination
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: HAhmed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD yet.

Drug and device information, study documents

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