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

NCT07562282 | Recruiting DMC

• 1 other identifier: Ureteric Stent
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Kidney Stone; Ureteric Stone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg)

ACTIVE COMPARATOR

About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms

Drug: Tamsulosin

Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)

ACTIVE COMPARATOR

About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

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.

Also known as: Tadalafil

Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg); Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• alpha reductase inhibitors

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Abbasia, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Calculi; Ureterolithiasis

Interventions

Tamsulosin; Tadalafil

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Waleed Mousa, Professor

  Assistant Professor of Urology Department of Urology Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Amr Mohammed Mounier, MSc

CONTACT

+201111984645; 160022@med.asu.edu.eg

Waleed Mousa, Professor

CONTACT

+201067628771; Waleedmousa@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Urology Department

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-12

Locations

EG (1)