Isokinetic StrengtheningSUINCT06835309
Isokinetic Strengthening of Hip Muscles Effect on Pelvic Floor Muscles Function in Females With SUI
A study testing Pelvic floor muscles exercises and Pelvic floor muscles exercises and isokinetic strengthening of hip muscles in people with Isokinetic Strengthening and Pelvic Floor Muscles, run by British University In Egypt at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the impact of isokinetic strengthening of hip muscles on pelvic floor muscles function in women experiencing stress urinary incontinence Does isokinetic strengthening of hip muscles impact pelvic floor muscles function in women experiencing stress urinary incontinence? Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Isokinetic Strengthening, Pelvic Floor Muscles, Stress Urinary Incontinence (SUI)
- What is being tested?
- Pelvic floor muscles exercises and Pelvic floor muscles exercises and isokinetic strengthening of hip muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2025to 23 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with stress urinary incontinence
- age between 30 and 50 years
Who cannot join
- low back pain
- lower limb muscle pathology and/or joint degeneration
- cardiovascular, metabolic or pulmonary disease
- body mass index (BMI) > 30 kg/m2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implications of Isokinetic Strengthening of Hip Muscles on Pelvic Floor Muscles Function in Women Experiencing Stress Urinary Incontinence
This study will be conducted to investigate the impact of isokinetic strengthening of hip muscles on pelvic floor muscles function in women experiencing stress urinary incontinence Does isokinetic strengthening of hip muscles impact pelvic floor muscles function in women experiencing stress urinary incontinence?
- Being tested
- Pelvic floor muscles exercises, Pelvic floor muscles exercises and isokinetic strengthening of hip muscles
- 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.
Pelvic floor muscles exercisesOther
The exercises for strengthening the PFM were 10 contractions of 5 seconds, 15 contractions of 3 seconds, 20 contractions of 2 seconds, 20 contractions of 1 second (equal rest time between contractions), and 5 repetitions of maximum contractions while coughing (1-minute interval).25 The level of difficulty of the exercises throughout the 20 sessions was determined by the patient's position, starting in a supine position, then progressing to a sitting position and, finally, to a standing position
Pelvic floor muscles exercises and isokinetic strengthening of hip musclesOther
The hip muscle strengthening exercise was executed on Biodex multi-joint system isokinetic dynamometer. Muscle tension of the lower limbs was relieved by executing 5-minute warm-up exercises using a cycle ergometer before execution of the isokinetic exercise For each hip muscle group, eight repetitions per set for 4 sets were carried out for a single exercise with a 30 second break between each set. The patient's position were the same positions used in the testing procedure. The exercises were carried out 3 times a week and the hip muscles strength evaluation was conducted after the end of the program intervention
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Pelvic floor muscles exercises Receives: Other: Pelvic floor muscles exercises |
| Treatment arm | Experimental | Pelvic floor muscles exercises and isokinetic strengthening of hip muscles Receives: Other: Pelvic floor muscles exercises and isokinetic strengthening of hip muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength
Perineometry to measure vaginal squeeze pressure (in mm hg) the more the grade, the better the muscle strength and so the less the stress urinary incontinence
Measured: 12 weeks
Secondary outcomes (1)
Stress urinary incontinence.
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) to evaluate the frequency, severity and impact on quality of life) the less the grade, the better the muscle strength and so the less the stress urinary incontinence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start23 Jan 2025
- Primary completion23 Apr 2025 (estimated)
- Study completion23 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isokinetic StrengtheningStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835309
- Sponsor's protocol ID
- P.T.REC/012/005601
- Acronym
- SUI
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Isokinetic Strengthening of Hip Muscles on Pelvic Floor Muscles Function in Women Experiencing Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06835309
- Acronym / sponsor ID
- SUI / P.T.REC/012/005601
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 23 Apr 2025 (estimated)
- Study completion
- 23 May 2025 (estimated)
- First posted
- 19 Feb 2025 (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 investigate the impact of isokinetic strengthening of hip muscles on pelvic floor muscles function in women experiencing stress urinary incontinence Does isokinetic strengthening of hip muscles impact pelvic floor muscles function in women experiencing stress urinary incontinence?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Other: Pelvic floor muscles exercisesPelvic floor muscles exercises |
| Treatment arm | Experimental | Other: Pelvic floor muscles exercises and isokinetic strengthening of hip musclesPelvic floor muscles exercises and isokinetic strengthening of hip muscles |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with stress urinary incontinence
- age between 30 and 50 years
Key exclusion criteria (4 listed)
- low back pain
- lower limb muscle pathology and/or joint degeneration
- cardiovascular, metabolic or pulmonary disease
- body mass index (BMI) > 30 kg/m2.
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 |
|---|---|---|
| Pelvic floor muscles exercisesThe exercises for strengthening the PFM were 10 contractions of 5 seconds, 15 contractions of 3 seconds, 20 contractions of 2 seconds, 20 contractions of 1 second (equal rest time between contractions), and 5 repetitions of maximum contractions while coughing (1-minute interval).25 The level of difficulty of the exercises throughout the 20 sessions was determined by the patient's position, starting in a supine position, then progressing to a sitting position and, finally, to a standing position | Other | Control arm |
| Pelvic floor muscles exercises and isokinetic strengthening of hip musclesThe hip muscle strengthening exercise was executed on Biodex multi-joint system isokinetic dynamometer. Muscle tension of the lower limbs was relieved by executing 5-minute warm-up exercises using a cycle ergometer before execution of the isokinetic exercise For each hip muscle group, eight repetitions per set for 4 sets were carried out for a single exercise with a 30 second break between each set. The patient's position were the same positions used in the testing procedure. The exercises were carried out 3 times a week and the hip muscles strength evaluation was conducted after the end of the program intervention | Other | Treatment arm |
Primary outcome
Pelvic floor muscle strength
Time frame: 12 weeks
Perineometry to measure vaginal squeeze pressure (in mm hg) the more the grade, the better the muscle strength and so the less the stress urinary incontinence
1 secondary outcome
Stress urinary incontinence.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Isokinetic Strengthening
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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.
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 Pelvic floor muscles exercises and Pelvic floor muscles exercises and isokinetic strengthening of hip muscles in people with Isokinetic Strengthening and Pelvic Floor Muscles, run by British University In Egypt 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 19 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Pelvic floor muscle strength (time frame: 12 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 19 Feb 2025.