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

Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms

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.

Study Overview

• Status: Recruiting
• Conditions: Ureteric Stone; Kidney Stone
• Intervention / Treatment: Drug: Tamsulosin

Detailed Description

Ureteral stents are commonly used for temporary drainage in various urological procedures. Despite their usefulness, they are frequently associated with bothersome symptoms collectively termed as "stent-related symptoms" (SRS),These symptoms include flank pain, lower urinary tract symptoms (LUTS), hematuria, dysuria, urgency, frequency, and sexual dysfunction.

The exact pathophysiology of SRS is multifactorial, involving local irritation, vesicoureteral reflux, and smooth muscle spasm.

Various pharmacological agents have been studied to alleviate these symptoms, with alpha-blockers and PDE-5 inhibitors showing promising results .

Tamsulosin, a selective al-blocker, reduces bladder neck and distal ureteral smooth muscle tone, alleviating irritative urinary symptoms.

Tadalafil, a PDE-5 inhibitor, has been shown to improve LUTS through its smooth muscle relaxation and increased perfusion effects. While both have been studied individually and in combination, the optimal dose of Tadalafil in combination therapy is yet to be clearly established

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Amr Mohammed Mounier, MSc; Phone Number: +201111984645; Email: 160022@med.asu.edu.eg
• Study Contact Backup: Name: Waleed Mousa, Professor; Phone Number: +201067628771; Email: Waleedmousa@med.asu.edu.eg

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt
      • Recruiting
      • Ain shams university hospital
      • Contact: Hisham Arafa, Lecturer; Phone Number: +201001921334; Email: Hishamarafa1988@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal.

Exclusion Criteria:

• Patients younger than 18 years of age were excluded.
• Patients with a history of prostate or bladder surgery were excluded.
• Patients with prior lower urinary tract procedures were excluded.
• Patients with cancer were excluded.
• Patients with neurological conditions were excluded.
• Patients with a history of pelvic radiation were excluded.
• Patients with diabetes were excluded.
• Patients with kidney dysfunction (acute or chronic) were excluded.
• Patients with a solitary kidney were excluded.
• Patients with congenital urinary anomalies were excluded.

• Patients taking the following medications were excluded:

  • α-blockers
  • beta-blockers
  • calcium channel blockers
  • 5-alpha reductase inhibitors
  • PDE5 inhibitors
  • anticholinergics
  • nitrates
• Patients with cardiac issues were excluded.
• Patients with residual stone fragments after surgery were excluded.
• Patients with multiple or bilateral ureteral stones were excluded.
• Patients with long-term or bilateral stents requiring frequent changes were excluded.
• Patients with interstitial cystitis were excluded.
• Patients with chronic cystitis were excluded.
• Patients with prostatitis were excluded.
• Pregnant women were excluded.
• Breastfeeding women were excluded.
• Patients unavailable for follow-up were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg); About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms	Drug: Tamsulosin; Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.; Other Names: Tadalafil
Active Comparator: Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg); About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms	Drug: Tamsulosin; Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.; Other Names: Tadalafil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Ureteral Stent Symptoms	Evaluation of Ureteral Stent Symptoms postoperatively using Questionnaire (USSQ) score after treatment (from 1 to 5) as: 1 is best relief of symptoms but 5 is worsen relief of symptoms	4 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Waleed Mousa, Professor, Assistant Professor of Urology Department of Urology Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 10, 2026

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Ureteral Diseases; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Ureterolithiasis; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Indoles; Benzene Derivatives; Indole Alkaloids; Benzenesulfonamides; Sulfonamides; Sulfones; Heterocyclic Compounds, 3-Ring; Carbolines; Tadalafil; Tamsulosin
• Other Study ID Numbers: Ureteric Stent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No