NCT06788704

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

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, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

January 17, 2025

Last Update Submit

January 25, 2025

Conditions

Erectile Dysfunction Following Urethral Surgery

Outcome Measures

Primary Outcomes (2)

  • Assess erectile function

    Using IIEF score

    One month

  • Assess erectile function

    Usine IIEF score

    3 month

Secondary Outcomes (2)

  • Assess storage symptoms

    One month

  • Assess storage symptoms

    3 month

Study Arms (2)

Patient recive tadalafil 5mg once daily early post turp

Drug: Tadalafil 5mg

Patient recive placebo once daily early post turp

Drug: Placebo

Interventions

Tadalafil 5mgDRUG

Patient recive tadalafil 5mg once daily early post turp

Patient recive tadalafil 5mg once daily early post turp
PlaceboDRUG

Patient recive placebo once daily early post turp

Patient recive placebo once daily early post turp

Eligibility Criteria

Sexmale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sexual active male patients underwent TURP

You may qualify if:

  • sexual active men

You may not qualify if:

  • sexual inactive men
  • cardiac patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elsayed Abdelhalim Elsayed

Zagazig, 44749, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 40588736DERIVED

MeSH Terms

Interventions

Tadalafil

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of urology

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

May 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

EG(1)