Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones

NCT ID: NCT05789732

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2022-08-30

Brief Summary

This study will compare the efficacy of silodosin, tadalafil versus silodosin plus tadalafil as Medical Expulsive Therapy (MET) for lower ureteric stones.

Detailed Description

The global incidence of urolithiasis, a disease with a high recurrence rate, is increasing. Urolithiasis is one of the most common disorders of the urinary tract with a lifetime prevalence of up to 15% with men affected three times more than women.

Urolithiasis causes recurrent stone formers to experience a decline in quality of life, and there is an increasing socioeconomic burden associated with the management of urolithiasis. Improved quality of life may also have increased its prevalence. A significant proportion, about 1/5th of urinary tract stones, is found in the ureter, of which 2/3rd is seen in the distal ureter. Initially, a colicky pain of various grades presents with ureteric stone. It is one of the most common problems that compel a patient to an emergency room.

Methods to manage ureteral stones include conservative treatment, pharmacological treatment (e.g., medical expulsive therapy), shock wave lithotripsy, and surgical treatment. Thus, urologists must select the appropriate treatment for each patient (i.e., non-surgical or surgical). Today, medical expulsive therapy has become the most used modality of treatment for urolithiasis. During this treatment, the ureter smooth muscle is treated via various drugs by different mechanisms.

Blocking alpha-(α-) 1 adrenergic receptor, especially in the distal third decreases basal smooth muscle contraction and causes propulsive antegrade peristalsis helping stone expulsion. By increasing the intraureteral pressure gradient around the stone, alpha-1 adrenergic receptor antagonists eject distal ureteral stones.

Significant pathological changes can occur when ureteric stones are impacted. +is can cause an inflammatory reaction with mucosal edema which could further worsen the ureteric obstruction, increasing the risk of impaction and retention. However, selective alpha-1 blockers, such as tamsulosin and silodosin, have been the treatment of choice, with proven efficacy in multiple clinical trials. Silodosin is a more selective α-1A adrenoceptor blocker with a better stone expulsion rate than tamsulosin.

Recently, a newer Phosphodiesterase type 5 inhibitor, tadalafil, has shown action on the nitric oxide-cyclic guanosine monophosphate signaling pathway of smooth muscles, resulting in increased levels of cyclic guanosine monophosphate, causing ureteric relaxation.

Due to its smooth muscle relaxation mechanism, tadalafil has received US Food and Drug Administration approval to treat many urinary tract diseases. Therefore, the combination of silodosin and tadalafil drugs is aimed to facilitate stone passage by better ureteric relaxation and reducing intramural ureter pressure. Although there have been few similar studies using various combinations, comparing the efficacy of silodosin and tadalafil vs. silodosin are very few, and these studies have taken longer duration of treatment (4 to 6 weeks) which might have affected the outcome.

Conditions

Lower Ureteric Stones; Medical Expulsive Therapy; Tadalafil; Silodosin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo group

Patients in this group will receive placebo treatment once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will receive placebo treatment once daily.

Silodosin group

Patients will receive Silodosin 8 mg once daily.

Group Type: EXPERIMENTAL

Silodosin

Intervention Type: DRUG

Patients will receive Silodosin 8 mg once daily.

Tadalafil group

Patients will receive Tadalafil 5 mg once daily.

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

Patients will receive Tadalafil 5 mg once daily.

Silodosin and Tadalafil

Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.

Group Type: EXPERIMENTAL

Silodosin and Tadalafil

Intervention Type: DRUG

Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.

Interventions

Placebo

Patients will receive placebo treatment once daily.

Intervention Type: DRUG

Silodosin

Patients will receive Silodosin 8 mg once daily.

Intervention Type: DRUG

Tadalafil

Patients will receive Tadalafil 5 mg once daily.

Intervention Type: DRUG

Silodosin and Tadalafil

Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 168 patients aged >18 years old.
• Both sexes.
• Diagnosed with lower ureteric stone from 5mm to 10mm in size.

Exclusion Criteria

• Patients with multiple or bilateral ureteric stones
• single kidney or impairment of renal function
• Urinary tract infection (UTI)
• Marked hydronephrosis
• Patients presenting with severe intractable pain and requiring emergency intervention
• Any urologic anomalies or history of ureteral surgery
• Pregnancy
• Pediatric populations
• Ischemic heart disease
• Congestive cardiac failure
• Complicated hypertension
• Patients on concomitant treatment with nitrates or calcium channel blockers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Tamer Abd El-Wahab Diab

Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University Hospitals

Banhā, , Egypt

Countries

Egypt

Other Identifiers

Rc 22-3-2023

Identifier Type: -

Identifier Source: org_study_id