Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary IncontinenceNCT05803486
Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary Incontinence
An observational study of Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary Incontinence, run by Deraya University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate Correlation between quadratus lumborum , pelvic floor muscles and diaphragm in patients with urinary incontinence Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary Incontinence
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 20 Mar 2023
- Phase
- Observational
- 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 40 years
- Women only
- Adult
Study population: - Their ages varied from 30to 40years, their body mass index (BMI) was 25-30 kg/m2 and a number of parities ≤ three normal vaginal deliveries, at least two years and Subjects hadn't received drugs
Who may be able to join
- - Their ages varied from 30to 40years, their body mass index (BMI) was 25-30 kg/m2 and a number of parities ≤ three normal vaginal deliveries, at least two years and Subjects hadn't received drugs , urinary incontinence mild or modrate
Who cannot join
- 1. History of spinal surgery or spinal fracture. 2. Volunteers with a history of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection, diabetes, intrauterine device, chest and/or cardiac disease and using any drugs for urinary incontinence 3. Serious diseases, such as heart disease, kidney, liver diseases, gastric ulcer or duodenal ulcer.
- 4. A history of bronchial asthma or any chest disease. 5. Uncontrolled diabetes or hypertension. 6. Patients with peacemaker or any metal implant on the treated area. 7. Cancer or patient with past history of tumor excision.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate Correlation between quadratus lumborum , pelvic floor muscles and diaphragm in patients with urinary incontinence
Read the detailed description
50 patients were distributed randomly into two groups. The first group measured ultrasound imaging for quadratus lumborum , pelvic floor muscles and diaphragm urinary incontinence female The second group measured ultrasound imaging for quadratus lumborum , pelvic floor muscles and diaphragm urinary incontinence female normal females.
Patients examined with medical ultrasound imaging .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | examined by ultrasound image to measure quadratus lumborum thickness, pelvic floor muscles force and diaphragm excursion in patients with urinary incontinence | |
| control group | examined by ultrasound image to measure quadratus lumborum thickness, pelvic floor muscles force and diaphragm excursion in patients with urinary incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force of contraction of pelvic floor muscles
by ultrasound imaging, convex transducer was used at a frequency of 5 MHz for evaluating. Voluntary PFM contractions' force (strength) of all patients.
Measured: 2 months
Secondary outcomes (1)
diaphragm excursion
by ultrasound imaging, convex transducer was used at a frequency of 5 MHz for evaluating. Voluntary diaphragm excursion
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jan 2023
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- doaa A.Nasser abdelhady, Principal investigator, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803486
- Sponsor's protocol ID
- 2\2023
- Status last verified
- Sep 2023
- First submitted
- 27 Mar 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05803486
- Acronym / sponsor ID
- 2\2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 7 Apr 2023 (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.
The purpose of this study is to investigate Correlation between quadratus lumborum , pelvic floor muscles and diaphragm in patients with urinary incontinence
Detailed description
50 patients were distributed randomly into two groups. The first group measured ultrasound imaging for quadratus lumborum , pelvic floor muscles and diaphragm urinary incontinence female The second group measured ultrasound imaging for quadratus lumborum , pelvic floor muscles and diaphragm urinary incontinence female normal females.
Patients examined with medical ultrasound imaging .
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –examined by ultrasound image to measure quadratus lumborum thickness, pelvic floor muscles force and diaphragm excursion in patients with urinary incontinence |
| control group | – | –examined by ultrasound image to measure quadratus lumborum thickness, pelvic floor muscles force and diaphragm excursion in patients with urinary incontinence |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- - Their ages varied from 30to 40years, their body mass index (BMI) was 25-30 kg/m2 and a number of parities ≤ three normal vaginal deliveries, at least two years and Subjects hadn't received drugs
Key inclusion criteria (1 listed)
- - Their ages varied from 30to 40years, their body mass index (BMI) was 25-30 kg/m2 and a number of parities ≤ three normal vaginal deliveries, at least two years and Subjects hadn't received drugs , urinary incontinence mild or modrate
Key exclusion criteria (2 listed)
- 1. History of spinal surgery or spinal fracture. 2. Volunteers with a history of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection, diabetes, intrauterine device, chest and/or cardiac disease and using any drugs for urinary incontinence 3. Serious diseases, such as heart disease, kidney, liver diseases, gastric ulcer or duodenal ulcer.
- 4. A history of bronchial asthma or any chest disease. 5. Uncontrolled diabetes or hypertension. 6. Patients with peacemaker or any metal implant on the treated area. 7. Cancer or patient with past history of tumor excision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Force of contraction of pelvic floor muscles
Time frame: 2 months
by ultrasound imaging, convex transducer was used at a frequency of 5 MHz for evaluating. Voluntary PFM contractions' force (strength) of all patients.
1 secondary outcome
diaphragm excursion
Time frame: 2 months
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 28 Sep 2023.
- Individual participant dataSharing planned: No
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.
doaa A.Nasser abdelhady principal investigator
Deraya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary Incontinence, run by Deraya 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 1 inclusion and 2 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 28 Sep 2023. 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?
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?
Force of contraction of pelvic floor muscles (time frame: 2 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 28 Sep 2023.