NCT06260917

Brief Summary

There are many factors that affect uroflowmetry parameters. One of these is the urination position. Research has mostly focused on standing and sitting urination positions. However, those who prefer the standing position as a habit can urinate by opening the zipper or lowering the trousers. Although the effect of these two applications on uroflowmetry parameters in healthy men has been investigated in only one study, their effect on patients with lower urinary tract symptoms has not been examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

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

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

February 6, 2024

Last Update Submit

February 13, 2024

Conditions

Keywords

benign prostatic obstructionuroflowmetryurodynamics

Outcome Measures

Primary Outcomes (4)

  • Qmax

    During the procedure

  • PVR

    Immediately after procedure

  • Qave

    During the procedure

  • Duration of voiding

    During the procedure

Study Arms (2)

urination through zipper

Diagnostic Test: position of urination

urinating by pulling down trousers

Diagnostic Test: position of urination

Interventions

position of urinationDIAGNOSTIC_TEST

effect of position on uroflowmetry parameters

urinating by pulling down trousersurination through zipper

Eligibility Criteria

Age45 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients on alpha blocker therapy with LUTS due to BPO

You may qualify if:

  • Having lower urinary tract symptoms due to BPO

You may not qualify if:

  • Having a neurogenic bladder
  • Previous prostate surgery
  • Having urethral stricture
  • Bladder neck stenosis
  • Having a bladder stone or tumor
  • Having a urinary system infection
  • Finding a suspicious nodule in digital rectal examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic HyperplasiaUrination DisordersUrologic Diseases

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 15, 2024

Study Start

November 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations