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

Sponsor
Deraya University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05803512
Collaborator
(none)
92
Enrollment
1
Location
2.4
Anticipated Duration (Months)
38.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    92 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Predicting Female Pelvic Tilt and Lumbar Angle Using Machine Learning in Case of Urinary Incontinence and Sexual Dysfunction
    Actual Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Apr 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    experimental group

    urinary incontinence females with sexual dysfunction
    control group

    Normal females

    Outcome Measures

    Primary Outcome Measures

    1. Pelvic tilt, lumbar angle [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).

    Secondary Outcome Measures

    1. Force of contraction of pelvic floor muscles [2 months]

      muscles by ultrasound imaging, convex transducer was used at a frequency of 5 MHz for evaluating. Voluntary PFM contractions' force (strength) of all patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
      • 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
    Exclusion Criteria:
      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.
    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Deraya university New Minya Egypt

    Sponsors and Collaborators

    • Deraya University

    Investigators

    • Principal Investigator: tarek Abd Elhafez, Deraya University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deraya University
    ClinicalTrials.gov Identifier:
    NCT05803512
    Other Study ID Numbers:
    • 1\2023
    First Posted:
    Apr 7, 2023
    Last Update Posted:
    Apr 7, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis

    Study Results

    No Results Posted as of Apr 7, 2023