NCT05834270

Brief Summary

Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

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

May 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 17, 2023

Last Update Submit

April 17, 2023

Conditions

Prostatic NeoplasmsProstate DiseaseProstate ObstructionProstate Hypertrophy

Keywords

TamsulosinProstate

Outcome Measures

Primary Outcomes (1)

  • Change in the lower urinary tract symptoms

    Assessed by the improvement in the internal prostatic symptoms score (IPSS)

    3 months

Study Arms (2)

Single dose tamsulosin 0.4mg

ACTIVE COMPARATOR

Single dose tamsulosin 0.4mg

Drug: Single dose tamsulosin 0.4mg

Double dose tamsulosin 0.4mg

ACTIVE COMPARATOR

Double dose tamsulosin 0.4mg

Drug: Double dose tamsulosin 0.4mg

Interventions

Single dose tamsulosin 0.4mgDRUG

Single dose tamsulosin 0.4mg

Single dose tamsulosin 0.4mg
Double dose tamsulosin 0.4mgDRUG

Double dose tamsulosin 0.4mg

Double dose tamsulosin 0.4mg

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age more than 50 years
  • moderate to severe lower urinary tract symptoms

You may not qualify if:

  • prostatic cancer
  • urethral stricture
  • prostate surgery
  • Neurogenic bladder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Shibīn al Kawm, Menofia, 342007, Egypt

Location

MeSH Terms

Conditions

Prostatic NeoplasmsProstatic DiseasesProstatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 28, 2023

Study Start

May 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)