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Impact of Tadalafil 5 mg on Post-micturition Dribble in Young-age Men With no/Mild Lower Urinary Tract Symptoms

NCT05146674 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-01-11

No results posted yet for this study

Summary

The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of tadalafil 5 mg on post-micturition dribble (PMD) in young age men (18-50 years) with no/mild lower urinary tract symptoms (LUTS).

Conditions

  • Lower Urinary Tract Symptoms

Interventions

DRUG

Tadalafil 5mg

Our prospective, randomized, study will consist of a 1-week baseline period and 12-week double-blind treatment period During the baseline period, patients' characteristics, including medical and sexual history, physical examination results, vital signs, HPMDQ score, IPSS, International Index of Erectile Function (IIEF) score, PMD volume, and uroflowmetry results; and laboratory results, including urine analysis results, will be recorded. After the baseline period, patients will be randomly assigned, 1:1, to the treatment or control groups using a computer-generated system. Both study groups will be advised to do bulbar urethral massage in addition to pelvic floor muscle exercise (explained later) during the study period, treatment group will be given tadalafil 5 mg (treatment group) daily or no medication (control group).

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Amr A Elsawy · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-12-01
Completion
2023-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05146674 on ClinicalTrials.gov