The Purpose of This Study is to Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual DysfunctionNCT05803512

Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual Dysfunction

An observational study of The Purpose of This Study is to Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual Dysfunction, run by Deraya University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to Predicting female pelvic tilt and lumbar angle using machine learning in case of urinary incontinence and sexual dysfunction Read more about this study

Who is it for?: Ages 30 to 40 years, women only
Conditions the study is for: The Purpose of This Study is to Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual Dysfunction
How many people: 92 participants
Where: 1 siteEgypt
Study dates: 1 Feb 2023to 15 Apr 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

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, patients with mild and moderate urinary incontinence with sexual dysfunction

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.

Egypt1 site

Deraya university
Minya

Other trials in Egypt

About this study

The purpose of this study is to Predicting female pelvic tilt and lumbar angle using machine learning in case of urinary incontinence and sexual dysfunction

Read the detailed description

92 patients were distributed randomly into two groups. The first group will be measured pelvic tilt, lumbar angle by spinal mouse and force of contraction of pelvic floor muscles by ultrasound imaging, UDI-6 and FSFI questionnaires for urinary incontinence female The second group will be measured pelvic tilt, lumbar angle by spinal mouse device and force of contraction of pelvic floor muscles by ultrasound imaging, UDI-6 and FSFI questionnaires for normal females.

Patients will be examined by radiologist with medical ultrasound imaging and by me with spinal mouse device.

Conditions: The Purpose of This Study is to Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual Dysfunction
Medical subject headings: Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05803512
Study group	Role	What they receive
experimental group		urinary incontinence females with sexual dysfunction
control group		Normal females

What is being measured

The primary outcome is the main question the study is designed to answer.

Pelvic tilt, lumbar angle
by spinal mouse device evaluation was carried out with the individuals standing erect and in the maximum trunk flexion and extension postures. The sagittal curvatures of the thoracic spine (T1-2 to T11-12) and lumbar spine (T12-L1 to the sacrum) were measured, as well as the position of the sacrum and hips (difference between the sacral angle and the vertical position).
Measured: 2 months

Secondary outcomes (1)

Force of contraction of pelvic floor muscles
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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202315 Apr 2023

First posted7 Apr 2023
Study start1 Feb 2023
Primary completion1 Apr 2023
Study completion15 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for The Purpose of This Study is to Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual DysfunctionStudies 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: Prospective
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05803512
Sponsor's protocol ID: 1\2023
Status last verified: Sep 2023
First submitted: 27 Mar 2023
Last updated: 26 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual Dysfunction
ClinicalTrials.gov ID: NCT05803512
Acronym / sponsor ID: 1\2023
Conditions: The Purpose of This Study is to Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual Dysfunction
Study type: Observational
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Deraya UniversityUniversity, hospital or other
Study start: 1 Feb 2023 (actual)
Primary completion: 1 Apr 2023 (actual)
Study completion: 15 Apr 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 Predicting female pelvic tilt and lumbar angle using machine learning in case of urinary incontinence and sexual dysfunction

Detailed description

Patients will be examined by radiologist with medical ultrasound imaging and by me with spinal mouse device.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
experimental group	–	–urinary incontinence females with sexual dysfunction
control group	–	–Normal females

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

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, patients with mild and moderate urinary incontinence with sexual dysfunction

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

Pelvic tilt, lumbar angle
Time frame: 2 months
by spinal mouse device evaluation was carried out with the individuals standing erect and in the maximum trunk flexion and extension postures. The sagittal curvatures of the thoracic spine (T1-2 to T11-12) and lumbar spine (T12-L1 to the sacrum) were measured, as well as the position of the sacrum and hips (difference between the sacral angle and the vertical position).

1 secondary outcome

Force of contraction of pelvic floor muscles
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 26 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.

tarek Abd Elhafez 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?

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 26 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?

Pelvic tilt, lumbar angle (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05803512.

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 26 Sep 2023.