Urinary Stress IncontinenceNCT06376903
Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women
A study testing Pilates exercise - pelvic floor exercise - home advices in people with Urinary Stress Incontinence, run by Cairo University.
Trial summary
This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Pilates exercise - pelvic floor exercise - home advices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 20 Sep 2024
- 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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria:Postmenopausal women (at least 12months after menstrual cessation), diagnosed with SUI by the gynecologist.
- Their ages will range from 50-60 years old .
- Their BMI will be less than 30kg/m2 .
- All of them suffer from mild to moderate degree of SUI .
- All of them delivered vaginally.
- All are multipara with 2 or more children.
- All are of sedentary life style.
Exclusion Criteria:Women will be excluded from the study if they have:
- Previous bladder surgery.
- Post pelvic radiotherapy.
- Vaginal/abdominal hysterectomy.
- Vaginal infection.
- Severe urinary tract infection.
- Uterine Prolapse
Trial locations and contacts
No sites are listed yet.
About this study
- This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women
Read the detailed description
Pilates exercises help in the controlled movement of the core, that act as a corset and it activates both core muscle and synergistically the PFM. (Trantafylidis, 2009).
There is limited evidence regarding the use of Pilates exercises for the management of stress urinary incontinence (SUI) in older women (Keri, 2013; Pyria et al, 2021). So this study will be conducted to determine the effect of Pilates exercises on SUI in postmenopausal women which provide an insight about the benefits of such exercise on postmenopausal SUI.
- Conditions
- Urinary Stress Incontinence
- Being tested
- Pilates exercise - pelvic floor exercise - home advices
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercise - pelvic floor exercise - home advicesOther
Also called Pelvic floor exercise - home care advices
Group (A) (Study group): It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform program of pilates exercises, 3 sessions/week (30 minutes a session ) for 12 weeks in addition to Kegel exercises (15min/three times per week/ for 12 weeks) and home care advices.
- Group (B) (Controlled group): It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform kegel exercises (15min/three times per week/ for 12 weeks) and home care advices as in group (A).
| Study group | Role | What they receive |
|---|---|---|
| Study group ; of pilates exercises,Kegel exercises,and home care advices.advices | Active comparator | •study group : It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform program of pilates exercises, 3 sessions/week (30 minutes a session ) for 12 weeks in addition to Kegel exercises (15min/three times per week/ for 12 weeks) and home care advices. Receives: Other: Pilates exercise - pelvic floor exercise - home advices |
| Controlled group;Kegel exercises,and home care advices. | Active comparator | Controlled group : It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform kegel exercises (15min/three times per week/ for 12 weeks) and home care advices as in group (A). Receives: Other: Pilates exercise - pelvic floor exercise - home advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Revised urinary incontinence scale
: It is considered one of the tools which used to diagnose SUI. It takes the five best items which loaded on the urinary leakage. The items comprising this revised scale include urine leakage related to the feeling of urgency, urine leakage related to physical activity, coughing or sneezing, small amounts of urine leakage [drops]) as well as two items related to frequency and amount of incontinence Scoring is by simple summation and the range of the total score is between zero and 12(0= no incontinence , 1-2= slight incontinence , 3-6= moderate incontinence , 7-9= severe incontinence , 12= very severe incontinence)
Measured: 6 weeks
Secondary outcomes (1)
• Quality of Life Questionnaire (QOL) for stress urinary incontinence
: it has been developed to provide detailed information on how urinary incontinence affects patients' lives. It is a valid and reliable instrument for assessing QOL in women with voiding symptoms, including urinary incontinence. It includes questions that evaluate the distress and impact of urinary incontinence in three domains: avoidance and limiting behavior, social embarrassment and psychosocial impact
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mohmedy Mosa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376903
- Sponsor's protocol ID
- P.T.REC/012/004860
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women
- ClinicalTrials.gov ID
- NCT06376903
- Acronym / sponsor ID
- P.T.REC/012/004860
- Conditions
- Urinary Stress Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 22 Apr 2024 (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.
- This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women
Detailed description
Pilates exercises help in the controlled movement of the core, that act as a corset and it activates both core muscle and synergistically the PFM. (Trantafylidis, 2009).
There is limited evidence regarding the use of Pilates exercises for the management of stress urinary incontinence (SUI) in older women (Keri, 2013; Pyria et al, 2021). So this study will be conducted to determine the effect of Pilates exercises on SUI in postmenopausal women which provide an insight about the benefits of such exercise on postmenopausal SUI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group ; of pilates exercises,Kegel exercises,and home care advices.advices | Active comparator | Other: Pilates exercise - pelvic floor exercise - home advices•study group : It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform program of pilates exercises, 3 sessions/week (30 minutes a session ) for 12 weeks in addition to Kegel exercises (15min/three times per week/ for 12 weeks) and home care advices. |
| Controlled group;Kegel exercises,and home care advices. | Active comparator | Other: Pilates exercise - pelvic floor exercise - home advicesControlled group : It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform kegel exercises (15min/three times per week/ for 12 weeks) and home care advices as in group (A). |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Pilates exercise - pelvic floor exercise - home advicesAlso: Pelvic floor exercise - home care advicesGroup (A) (Study group): It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform program of pilates exercises, 3 sessions/week (30 minutes a session ) for 12 weeks in addition to Kegel exercises (15min/three times per week/ for 12 weeks) and home care advices. • Group (B) (Controlled group): It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform kegel exercises (15min/three times per week/ for 12 weeks) and home care advices as in group (A). | Other | Controlled group;Kegel exercises,and home care advices., Study group ; of pilates exercises,Kegel exercises,and home care advices.advices |
Primary outcome
• Revised urinary incontinence scale
Time frame: 6 weeks
: It is considered one of the tools which used to diagnose SUI. It takes the five best items which loaded on the urinary leakage. The items comprising this revised scale include urine leakage related to the feeling of urgency, urine leakage related to physical activity, coughing or sneezing, small amounts of urine leakage [drops]) as well as two items related to frequency and amount of incontinence Scoring is by simple summation and the range of the total score is between zero and 12(0= no incontinence , 1-2= slight incontinence , 3-6= moderate incontinence , 7-9= severe incontinence , 12= very severe incontinence)
1 secondary outcome
• Quality of Life Questionnaire (QOL) for stress urinary incontinence
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise - pelvic floor exercise - home advices in people with Urinary Stress Incontinence, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MANAL AHMED EL-SHAFEI, PHD (+201220664518 ext. +201220664518, Manalpt1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Revised urinary incontinence scale (time frame: 6 weeks). 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 22 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.