Actively Recruiting

Phase Not Applicable
Age: 18Years - 71Years
All Genders
NCT07562282

Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg

Led by Ain Shams University · Updated on 2026-05-01

140

Participants Needed

1

Research Sites

31 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Ureteral stenting is a common urological procedure performed to relieve obstruction and facilitate urinary drainage. Despite its effectiveness, stent-related symptoms (SRS) such as dysuria, frequency, urgency, flank pain, and sexual discomfort negatively affect patient quality of life. Pharmacological management with alpha-blockers such as Tamsulosin and phosphodiesterase-5 inhibitors (PDE5i) such as Tadalafil has shown promise in reducing SRS. While low-dose Tadalafil (2.5 mg) has not been explored, its comparative effectiveness against the standard 5 mg dose when combined with Tamsulosin remains under-researched. This study aims to evaluate the difference in reduction of SRS between Tamsulosin with Tadalafil in standard and half dosage.

CONDITIONS

Official Title

Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg

Who Can Participate

Age: 18Years - 71Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years of age
  • Presence of a double-J (DJ) stent (polyurethane) after endoscopic stone removal
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years of age
  • History of prostate or bladder surgery
  • Prior lower urinary tract procedures
  • History of cancer
  • Presence of neurological conditions
  • History of pelvic radiation
  • Diagnosis of diabetes
  • Kidney dysfunction (acute or chronic)
  • Presence of a solitary kidney
  • Congenital urinary anomalies
  • Current use of alpha-blockers, beta-blockers, calcium channel blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, anticholinergics, or nitrates
  • Cardiac issues
  • Residual stone fragments after surgery
  • Multiple or bilateral ureteral stones
  • Long-term or bilateral stents requiring frequent changes
  • Interstitial cystitis
  • Chronic cystitis
  • Prostatitis
  • Pregnancy
  • Breastfeeding
  • Unavailability for follow-up

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Ain Shams University Hospital

Cairo, Abbasia, Egypt

Actively Recruiting

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Research Team

A

Ahmed Amr Mohammed Mounier, MSc

CONTACT

W

Waleed Mousa, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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