Single Dose Versus Double Dose Tamsulosin in Management o... | NCT05834270

Studies
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH

NCT05834270

Sponsor

Menoufia University

Status

Completed

Last Update Posted

Apr 28, 2023Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Prostatic Neoplasms
Prostate Disease
Prostate Obstruction
Prostate Hypertrophy

Interventions

Single dose tamsulosin 0.4mg
Double dose tamsulosin 0.4mg

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 1, 2022Actual

First Submitted Date

Apr 17, 2023

First Submission Date that Met QC Criteria

Apr 17, 2023

First Posted Date

Apr 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2023

Last Update Posted Date

Apr 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Single dose tamsulosin 0.4mg	Drug	Single dose tamsulosin 0.4mg	Single dose tamsulosin 0.4mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the lower urinary tract symptoms	Assessed by the improvement in the internal prostatic symptoms score (IPSS)	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

prostatic cancer
urethral stricture
prostate surgery
Neurogenic bladder

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Shibīn al Kawm	Menofia	342007	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D011469	Prostatic Diseases
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided