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

Lower Ureteric Stones Clinical Trial

Official title:

Efficacy of Silodosin, Tadalafil Alone Versus Silodosin Plus Tadalafil as Medical Expulsive Therapy for Lower Ureteric Stones: A Prospective Randomized Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789732
• Other study ID #: Rc 22-3-2023
• Status: Completed
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: March 2023
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Ureteric Stones
• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• Placebo
Patients will receive placebo treatment once daily.
• Silodosin
Patients will receive Silodosin 8 mg once daily.
• Tadalafil
Patients will receive Tadalafil 5 mg once daily.
• Silodosin and Tadalafil
Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.

Locations

Country	Name	City	State
Egypt	Benha University Hospitals	Benha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone expulsion rate	Stone expulsion rate will be recorded	Intraoperatively
Secondary	Stone expulsion time	Stone expulsion time will be recorded	Intraoperatively
Secondary	Amount of analgesia used	The amount of analgesia used will be recorded	Intraoperatively