Urinary IncontinenceNCT05341778
Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence
A study testing Shoulder bridge, Clam shell and Scissors in people with Urinary Incontinence, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Shoulder bridge, Clam shell and Scissors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Apr 2022to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Urinary Incontinence
- Being tested
- Shoulder bridge, Clam shell, Scissors, Adductor squeeze, Pelvic clock supine
- Keywords
- Urinary incontinence, Older females, Pelvic floor disorders, Urination, Quality of life
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder bridgeOther
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 shellOther
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.
ScissorsOther
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 squeezeOther
Adductor Squeeze exercise The SQ exercise is an isometric hip adduction exercise with the player holding a ball between their knees.
Pelvic clock supineOther
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 inOther
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
BridgingOther
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 topOther
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercises | Experimental | 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. Receives: Other: Shoulder bridge; Other: Clam shell; Other: Scissors; Other: Adductor squeeze; Other: Pelvic clock supine; Device: Electrical muscle stimulation |
| Pelvic floor exercise | Active comparator | These exercises are intended to strengthen weak perineal and pelvic floor muscles. Receives: Other: Clam shell; Other: Adductor squeeze; Other: urine hold and tummy tuck in; Other: Bridging; Other: Split table top; Device: Electrical muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline and after 4 weeks
Secondary outcomes (1)
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.
Measured: baseline and after 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start26 Apr 2022
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute of Physical Medicine and Rehabilitation
- Responsible party
- Principal investigator, Humera Ahmed, Dow University of Health Sciences
- Investigators
- Aftab Ahmed Mirza Baig, MSAPT, Study director, Sindh Institute of Physical Medicine and RehabilitationHumera Ahmed, DPT, Principal investigator, Dow University of Health SciencesRabail Rani Soomro, MSPT, Study director, Sindh Institute of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341778
- Sponsor's protocol ID
- HAhmed
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2022
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD yet.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Exercises Versus Pelvic Floor Muscle Exercises Among Elderly Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05341778
- Acronym / sponsor ID
- HAhmed
- Conditions
- Urinary Incontinence
- Keywords
- Urinary incontinence, Older females, Pelvic floor disorders, Urination, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Collaborators
- The Institute of Physical Medicine and Rehabilitation
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates exercises | Experimental | Other: Shoulder bridge, Other: Clam shell, Other: Scissors, Other: Adductor squeeze, Other: Pelvic clock supine, Device: Electrical muscle stimulationThe 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. |
| Pelvic floor exercise | Active comparator | Other: Clam shell, Other: Adductor squeeze, Other: urine hold and tummy tuck in, Other: Bridging, Other: Split table top, Device: Electrical muscle stimulationThese exercises are intended to strengthen weak perineal and pelvic floor muscles. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder bridgeThe 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 | Pilates exercises |
| Clam shellScissors 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 | Pelvic floor exercise, Pilates exercises |
| ScissorsScissors 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 | Pilates exercises |
| Adductor squeezeAdductor Squeeze exercise The SQ exercise is an isometric hip adduction exercise with the player holding a ball between their knees. | Other | Pelvic floor exercise, Pilates exercises |
| Pelvic clock supineThe 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. | Other | Pilates exercises |
| urine hold and tummy tuck inDuring 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 | Pelvic floor exercise |
| BridgingA 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 | Pelvic floor exercise |
| Split table topTo 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 | Other | Pelvic floor exercise |
| Electrical muscle stimulationElectric 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. | Device | Pelvic floor exercise, Pilates exercises |
Primary outcome
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.
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.
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.
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.
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
1 secondary outcome
Change in Quality of life on Quality of life measures questionnaire scores after 4 weeks
Time frame: baseline and after 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No. There is no plan to share IPD yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aftab Ahmed Mirza Baig, MSAPT study director
Sindh Institute of Physical Medicine and Rehabilitation
Humera Ahmed, DPT principal investigator
Dow University of Health Sciences
Rabail Rani Soomro, MSPT study director
Sindh Institute of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder bridge, Clam shell and Scissors in people with Urinary Incontinence, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in volume of urine in millilitre on Voiding Diary after 4 weeks (time frame: baseline and after 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.