# Efficacy of Silodosin and Tadalafil monotherapy versus combination of both drugs as MET for distal ureteric stones: A prospective, double blinded, randomized clinical trial

## TL;DR

This study found that combining silodosin and tadalafil is more effective than using either drug alone for treating distal ureteric stones.

## Contribution

The study introduces a novel combination therapy for distal ureteric stones and compares its efficacy to monotherapies.

## Key findings

- Combined therapy had an 88.1% expulsion rate, higher than silodosin (71.4%) and tadalafil (61.4%).
- Combined therapy reduced expulsion time to 10.4 days, compared to 14.1 and 17.8 days for monotherapies.
- Combined therapy also reduced pain episodes, emergency visits, and analgesia use significantly.

## Abstract

To assess efficacy and safety of silodosin, tadalafil, versus combination of both medications as medical expulsive therapy (MET) for distal ureteric stones.

This prospective, double blinded, randomized clinical trial included 128 patients aged 18 years or more irrespective of gender who are presented to emergency department or outpatient with distal ureteric stones ranging in size from 5–10 mm, randomized into three groups: Group I (n = 42) received Silodosin 8 mg once daily, Group II (n = 44) received Tadalafil 5 mg once daily, and Group III (n = 42) received Silodosin 8 mg combined with Tadalafil 5 mg one daily. All participants underwent thorough history-taking, routine laboratory investigations, and clinical examinations.

The primary end point included expulsion rate and time and treatment tolerance. Secondary end points were number pain episodes, need for emergency room visit, amount of analgesia, need for intervention.

The expulsion rate was 71.4% for silodosin, 61.4% for tadalafil and 88.1% for combined therapy (p = 0.018). Expulsion time was significantly shorter after combined therapy 10.4 + 3.5 days, while after silodosin 14.1 + 4 days, while 17.8 + 3.4 days after tadalafil (p < 0.001). The number of pain episodes, emergency room visits, and the amount of analgesia were significantly in favour of combined therapy (p value 0.004, 0.010, and <0.001) respectively.

A combination of Silodosin with Tadalafil as a MET for distal ureteric stones is more effective than monotherapy with tolerable side effects.