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

April 10, 2025 updated by: Humera Ahmed, Dow University of Health Sciences
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Humera Ahmed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in volume of urine in millilitre on Voiding Diary after 4 weeks
Time Frame: baseline and 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
Time Frame: baseline and 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.
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Quality of life on Quality of life measures questionnaire scores after 4 weeks
Time Frame: baseline and after 4 week
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dow University of Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Institute of Physical Medicine and Rehabilitation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings