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Uroflowmetry Results and Vitamin D Levels

Sponsor
Umraniye Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04405141
Collaborator
(none)
186
Enrollment
11.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The investigators aimed to evaluate the relationship between LUTS and vitamin D with uroflowmetry parameters in female patients. They found no relation between vitamin D levels and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with urologic problems. The investigators believe that there is a need for studies emphasizing serum Ca levels in addition to vitamin D levels in patients with LUTS.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This retrospective cohort study included 186 female patients who admitted to LUTS. Demographic characteristics, medical history, calcium (Ca) and vitamin D including laboratory studies and uroflowmetry results as maximum urine flow rate (Qmax), average urine flow rate (Qav), and voided volume (V) were recorded. Patients were divided into two groups according to age (18-50 and ≥51) and vitamin D levels (<20 and ≥20).

    Laboratory parameters, uroflowmetry results, were compared between groups.

    The study was approved by the local ethics committee (approval#22/06/2018-09.29-54132726-000-14136). The study was conducted in accordance to the Helsinki Declaration and Good Clinical Practices Guidelines.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    186 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    The Relationship Between Vitamin D Level and Lower Urinary Tract Symptoms in Women
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Dec 30, 2017
    Actual Study Completion Date :
    Dec 30, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Uroflowmetry Results [12 months]

      There was no significant relationship between age, creatinine, Qmax, Qav, V and vitamin D level (P>0.05).

    Secondary Outcome Measures

    1. Vitamin D Levels [12 months]

      The mean D vitamin level was 21.19ng/ml. D vitamin was <20 ng/ml in %55.9 patients. There was no difference in the levels according to the age of all patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Clinical diagnosis of low urinary tract symptom

    Exclusion Criteria:

    Urinary tract infection, Diabetes mellitus, Neurological disorder, Pregnancy Stone disease Other urinary system disorders.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Umraniye Education and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sibel Ocak Serin, Principal investigator, Umraniye Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04405141
    Other Study ID Numbers:
    • UmraniyeERH
    First Posted:
    May 28, 2020
    Last Update Posted:
    Jun 1, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sibel Ocak Serin, Principal investigator, Umraniye Education and Research Hospital
    Lower Urinary Tract Symptoms
    Vitamin D Deficiency
    Calcium Deficiency
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Lower Urinary Tract Symptoms

    Study Results

    No Results Posted as of Jun 1, 2020