NCT05676346

Brief Summary

The aim of this study is to determinate the prevalence os genetic DAO deficiency in patients with lower urinary tract symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

December 22, 2022

Last Update Submit

February 6, 2023

Conditions

Lower Urinary Tract SymptomsHistamine Intolerance

Outcome Measures

Primary Outcomes (1)

  • Genetic DAO deficiency prevalence

    To estimate the prevalence of genetic diamine oxidase (DAO) deficiency in patients with lower urinary tract symptoms (LUTS).

    Baseline

Secondary Outcomes (2)

  • Descriptive data and genotype correlation

    Baseline

  • Histamine intolerance and lower urinary tract symptoms correlation

    Last 30 days

Study Arms (1)

LUTS

Patients with lower urinary tract symptoms with CACV \> 3 and/or IPSS \> 7.

Genetic: LUTS

Interventions

LUTSGENETIC

Patients included in this group are subjects with lower urinary tracto symptoms. An oral mucosa swab will be used to extract a genetic specimen

LUTS

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who attend Urology outpatient clinics for lower urinary tract symptoms.

You may qualify if:

  • CACV socre \> 3 and/or
  • IPSS score \> 7

You may not qualify if:

  • History of previous bladder and/or prostate surgery.
  • History of bladder tumor in the previous 3 months.
  • History of intravesical chemotherapy in the previous 3 months.
  • Active urinary tract infection in the previous 2 weeks.
  • Antihistamine treatment
  • History of colorectal surgery and/or previous abdomino-perineal amputation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose Luis Ponce Diaz-Reixa

A Coruña, 15006, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Oral mucosal swab Genetic single nucleotide polymorphisms rs2052129, rs10156191, rs1049742 and rs1049793

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigador. Head of Section. Urology Department.

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

October 11, 2022

Primary Completion

January 24, 2023

Study Completion

January 24, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

ES(1)