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Efficacy and Safety of Tadalafil, Tamsulosin, and Their Combinations in Treating Lower Urinary Tract Symptoms in BPH Patients with Prostate Volumes ≤ 40 Ml: a Prospective Comparative Study

NCT06809205 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2025-02-05

No results posted yet for this study

Summary

Abstract:

Objective: To examine the influence of tadalafil and tamsulosin versus their combinations in the treatment of lower urinary tract symptoms in mildly enlarged prostates below 40 ml in volume.

Materials and methods: A prospective randomized study was done at Fayoum and Beni-Suef University Hospitals in Egypt from December 2022 to August 2023. A total of 95 male participants aged over 45 years, all presenting with mild to intense lower urinary tract symptoms, were enrolled. Participants were randomized into three groups: Group A was administered Tamsulosin (0.4 mg per day), Group B was administered tadalafil (5 mg per day), and Group C was administered a mixture of both medications. The study assessed multiple parameters, the primary endpoint parameter was the International Prostate Symptom Score (IPSS) and the other secondary parameters were the five-item International Index of Erectile Function (IIEF-5), maximum urinary flow rate (Q-max), post-void residual urine (PVR), and the quality of life (QoL). At baseline, these parameters were assessed, followed by evaluations at 1, 3, and 6 months after treatment.

Key words. Tamsulosin, tadalafil, BPH and LUTS.

Conditions

  • BPH with Other Lower Urinary Tract Symptoms

Interventions

DRUG

Tamsulosin 0.4 mg

administered tamsulosin 0.4 mg

DRUG

Tadalafil 5mg

administered tadalafil 5 mg

DRUG

Tamsulosin and Tadalafil

administered tamsulosin 0.4 mg plus tadalafil 5 mg

Sponsors & Collaborators

  • Fayoum University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2024-05-20
Completion
2024-08-30

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 NCT06809205 on ClinicalTrials.gov