Tadalafil Daily Used Post Turp | NCT06788704

Studies
Tadalafil Daily Used Post Turp

NCT06788704

Sponsor

Kafrelsheikh University

Status

Completed

Last Update Posted

Jan 28, 2025Actual

Enrollment

270Actual

Phase

Not provided

Conditions

Erectile Dysfunction Following Urethral Surgery

Interventions

Tadalafil 5mg
Placebo

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

Jan 2025

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, 2021Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

Jan 17, 2025

First Submission Date that Met QC Criteria

Jan 17, 2025

First Posted Date

Jan 23, 2025Actual

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

Jan 25, 2025

Last Update Posted Date

Jan 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elsayed Abdelhalim Elsayed, assistant lecturer of urology, Kafrelsheikh UniversityPrincipal Investigator

Lead Sponsor

Kafrelsheikh UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

to assess the effect of early tadalafil 5 mg once daily on persistent storage lower urinary tract symptoms (LUTS) and erectile function after transurethral resection of the prostate (TURP).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

270Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient recive tadalafil 5mg once daily early post turp			Drug: Tadalafil 5mg
Patient recive placebo once daily early post turp			Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tadalafil 5mg	Drug	Patient recive tadalafil 5mg once daily early post turp	Patient recive tadalafil 5mg once daily early post turp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess erectile function	Using IIEF score	One month
Assess erectile function	Usine IIEF score	3 month

Secondary Outcomes

Measure	Description	Time Frame
Assess storage symptoms	Using IPSS Score	One month
Assess storage symptoms	Using IPSS score	3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sexual active men

Exclusion Criteria:

sexual inactive men
cardiac patients

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Sexual active male patients underwent TURP

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elsayed Abdelhalim Elsayed		Zagazig		44749	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40588736	Derived	Taha DE, Nabeeh H, Zeinelabden KM, Abdelhalim E, Elmekawy S, Samaha II, Behiry A, Elmoaty AA, Abdelbaky T, Ibrahim A. The effect of tadalafil 5 mg on erection and persistent storage lower urinary tract symptoms after transurethral resection of prostate: a randomized controlled study. Basic Clin Androl. 2025 Jul 1;35(1):27. doi: 10.1186/s12610-025-00273-2.

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds