Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones

Phase 4

• Conditions: Lower Ureteric Stones
• Interventions: Drug: Tadalafil versus tamsulosin as MET

• Registration Number: NCT04641507
• Lead Sponsor: Beni-Suef University

Brief Summary

The aim of the work is to compare the efficacy of tadalafil and tamsulosin as a medical expulsive therapy for lower ureteric stones

Detailed Description

Gradually increasing incidence rate of kidney stone is a significant concern of medical world. Genetics and/or life style accelerate the kidney stone formation (Urolithiasis). Sometimes, it is stuck up in ureter especially distal ureter; hence called as lower ureteral stone (LUS) and causes intense flank pain beside urinary obstruction.

The ureter contains α adrenergic receptors along its entire length with the highest concentration in the distal ureter.

There has been a steep rise in minimally invasive procedures but medical expulsive therapy (MET) is still regarded as an established treatment option for the management of distal ureteric stones.

Stone location, size, number, ureteric spasm, mucosal oedema or inflammation, and ureteric anatomy are the factors affecting passage of ureteric stones.

Drugs that expel stones might act by relaxing ureteral smooth muscle through inhibition of calcium channel pumps or α-1 receptor blockade. Tamsulosin is one of the most commonly used α-blockers.

Phosphodiesterase inhibitors (PDEi) are a class of drugs that inhibit the breakdown of cAMP and cGMP, enhancing smooth muscle relaxation. Therefore, PDEi may be able to decrease ureteral spasm and facilitate stone passage. Tadalafil is a selective PDE5i and because of its smooth muscle relaxation property, tadalafil received the US Food and Drug Administration approval for lower urinary tract symptoms with benign prostatic hyperplasia and erectile dysfunction.

Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms had already been demonstrated .

With demonstration of in vitro effects of phosphodiesterase-5 inhibitor (PDE5i) as tadalafil on isolated human ureteral smooth muscle, interest in use of PDE5i as MET has increased.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-23
• Status Verified: 2022-03
• Primary Completion: 2022-03-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04
• Study Completion: 2022-03-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Patients aged ≥18 years
• Patient have a distal ureteric stone of 5-9 mm in greatest dimension
• Patient diagnosed by ultrasonography of the kidney, ureter, and bladder , X-ray KUB and noncontrast computed tomography scan.

Exclusion Criteria

• Pregnant or lactating mothers.
• Patients have UTI.
• Patients have severe hydroureteronephrosis.
• Patients have multiple ureteric stones.
• Patients have solitary kidney.
• Patients have acute or chronic renal failure.
• Patients have previous therapies for the stone.
• Patients with history of open surgery/endoscopic interventions.
• Patients have ureteric strictures.
• Patients take concomitant treatment with calcium antagonists, β-blockers, corticosteroids or nitrates.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tadalafil treated group	Tadalafil versus tamsulosin as MET	83 patients with lower ureteric stone will take tadalafil 10 mg once daily. Therapy will be given for a maximum of 4 weeks.
Tamsulosin treated group	Tadalafil versus tamsulosin as MET	83 patient with lower ureteric stone will take tamsulosin 0.4 mg once daily .Therapy will be given for a maximum of 4 weeks.

Primary Outcome Measures

Name	Time	Method
Lower ureteric stone expulsion	4 weeks	Measuring lower ureteric stone expulsion rate with tadalafil versus tamsulosin

Trial Locations

Locations (1)

Ahmed Saleh; 🇪🇬 Giza, Egypt