Skip to main content
OpenTrials
Completed

NCT Number: NCT05341778

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pregnancy Complications Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Humera Ahmed

Karachi, Sindh, 74200, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shoulder bridge

Other

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.

Clam shell

Other

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.

Scissors

Other

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.

Adductor squeeze

Other

Adductor Squeeze exercise The SQ exercise is an isometric hip adduction exercise with the player holding a ball between their knees.

Pelvic clock supine

Other

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.

urine hold and tummy tuck in

Other

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

Bridging

Other

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.

Split table top

Other

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

Electrical muscle stimulation

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Collaborators

  • The Institute of Physical Medicine and Rehabilitation

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2022
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.