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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04405141
Other study ID # UmraniyeERH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 30, 2017

Study information

Verified date May 2020
Source Umraniye Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date December 30, 2017
Est. primary completion date December 30, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Umraniye Education and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Uroflowmetry Results There was no significant relationship between age, creatinine, Qmax, Qav, V and vitamin D level (P>0.05). 12 months
Secondary Vitamin D Levels 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. 12 months
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