Stress Urinary IncontinenceNCT06269016
Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women
A study testing expremental pre and post test in people with Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
Trial summary
this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Read more about this study
- Who is it for?
- Ages 30 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- expremental pre and post test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to 20 Apr 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 30 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their ages will be ranged from 30 to 35 years old.
- Their BMI will not exceed 35 Kg/m2.
- All patients will be multipara women.
- Their deliveries were normal vaginal delivery.
- All patients will be diagnosed by gynecologist as mild or moderate degree of SUI.
- All patients will have the same medical treatment and free from any pathological conditions that might affect the result.
Who cannot join
- Recurrent urinary tract infections.
- Hypertension.
- Diabetes mellitus.
- Intra uterine device.
- Hysterectomy.
Trial locations and contacts
1 site in 1 country.
About this study
this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general
- Conditions
- Stress Urinary Incontinence
- Being tested
- expremental pre and post test
- 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.
expremental pre and post testOther
effect of strengthening exercise of combined hip strengthening exercises and pelvic floor exercises
| Study group | Role | What they receive |
|---|---|---|
| control group no intervention | Experimental | no intervention for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form. Receives: Other: expremental pre and post test |
| study group hip muscles strengthening exercise. | Experimental | hip muscles exercises (hip abductors, adductors and gluteus maximus) for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form. Receives: Other: expremental pre and post test |
| study group hip muscles strengthening exercise combined with pelvic floor muscles exercise. | Experimental | hip muscles exercises (hip abductors, adductors and gluteus maximus) combined with pelvic floor muscles exercises for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form. Receives: Other: expremental pre and post test |
| study group pelvic floor muscles exercise. | Experimental | pelvic floor muscles exercises for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form. Receives: Other: expremental pre and post test |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip muscles strengthening exercise.
measure the muscle power and endurance for pelvic floor muscles by using bio feedback device to measure maximum vaginal squeeze
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start20 Feb 2023
- Primary completion25 Aug 2023
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Sherif Mohamed Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269016
- Sponsor's protocol ID
- P.T.REC/012/003888
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women
- ClinicalTrials.gov ID
- NCT06269016
- Acronym / sponsor ID
- P.T.REC/012/003888
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 21 Feb 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 investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group no intervention | Experimental | Other: expremental pre and post testno intervention for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form. |
| study group hip muscles strengthening exercise. | Experimental | Other: expremental pre and post testhip muscles exercises (hip abductors, adductors and gluteus maximus) for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form. |
| study group hip muscles strengthening exercise combined with pelvic floor muscles exercise. | Experimental | Other: expremental pre and post testhip muscles exercises (hip abductors, adductors and gluteus maximus) combined with pelvic floor muscles exercises for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form. |
| study group pelvic floor muscles exercise. | Experimental | Other: expremental pre and post testpelvic floor muscles exercises for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form. |
Who may qualify
- Ages
- 30 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Their ages will be ranged from 30 to 35 years old.
- Their BMI will not exceed 35 Kg/m2.
- All patients will be multipara women.
- Their deliveries were normal vaginal delivery.
- All patients will be diagnosed by gynecologist as mild or moderate degree of SUI.
Key exclusion criteria (5 listed)
- Recurrent urinary tract infections.
- Hypertension.
- Diabetes mellitus.
- Intra uterine device.
- Hysterectomy.
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 |
|---|---|---|
| expremental pre and post testeffect of strengthening exercise of combined hip strengthening exercises and pelvic floor exercises | Other | control group no intervention, study group hip muscles strengthening exercise combined with pelvic floor muscles exercise., study group hip muscles strengthening exercise., study group pelvic floor muscles exercise. |
Primary outcome
hip muscles strengthening exercise.
Time frame: 3 months
measure the muscle power and endurance for pelvic floor muscles by using bio feedback device to measure maximum vaginal squeeze
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expremental pre and post test in people with Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. 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 Egypt. 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?
Results are not available in the source record.
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?
hip muscles strengthening exercise. (time frame: 3 months). 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 21 Feb 2024.