NCT05818670

Brief Summary

Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

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 11, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
Last Updated

April 19, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 22, 2023

Last Update Submit

April 17, 2023

Conditions

BPH

Keywords

tamsulosintadalafilBPHRandomised triallongtermdiscontinuation rate

Outcome Measures

Primary Outcomes (1)

  • drug discontinuation rate

    drug discontinuation rate either : lack of response, adverse events or poor compliance

    12 months

Secondary Outcomes (4)

  • changes in urinary parameters

    12 months

  • changes in uroflowmetry

    12 months

  • changes in post voiding residual urine

    12 months

  • changes in sexual parameters

    12 months

Study Arms (2)

tamsulosin

ACTIVE COMPARATOR

patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up

Drug: Tamsulosin

tadalafil

ACTIVE COMPARATOR

patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up

Drug: Tadalafil

Interventions

TamsulosinDRUG

long term follow up

tamsulosin
TadalafilDRUG

long term follow up

tadalafil

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Lower Urinary Tract Symptoms
  • married and sexually active
  • age more than 50 years
  • IPSS more than 12
  • Q max less than 15 ml/s
  • Post voiding residual less than 150 ml

You may not qualify if:

  • prostatic adenocarcinoma
  • cardiac patients on nitrates, patient with unstable angina or recent history of myocardial infarction
  • vesical stones
  • active Urinary Tract Infection
  • patient refused participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Atta Elqaffas

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Urology and Nephrology Center at Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Interventions

TamsulosinTadalafil

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsCarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • ahmed A elqaffas, master

    Mansoura urology and nephrology center (UNC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 19, 2023

Study Start

November 11, 2020

Primary Completion

September 22, 2021

Study Completion

September 17, 2022

Last Updated

April 19, 2023

Record last verified: 2023-03

Locations

EG(2)