NCT06319469

The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention

The Additive Value of Pyridostigmine to Silodosin in the Management of Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Acute urine retention, AUR, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (BPH). AUR is defined as the sudden and painful inability to void freely. This study aims to evaluate whether pyridostigmine bromide added to silodosin is beneficial in treating acute urine retention caused by BPH.

Detailed description

AUR, or acute urine retention, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (BPH). AUR is defined as the sudden and painful inability to void freely. (Hartung, 2001). Between 0.4 and 25% of males seen in routine urological care are reported to have AUR each year (Schulman, 2001). According to a significant US cohort study, if a 60-year-old man survived for another 20 years, his probability of experiencing an AUR episode would be 23% (Jacobsen et al., 1997). The current standard of care for AUR typically involves immediate bladder catheterization, followed by subsequent removal of the catheter to test whether normal voiding returns, that is, a trial without a catheter (TWOC) (Gwon et al., 2023).

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet	The participants were assigned to groups A and B. Group B received the 8 mg silodosin capsule. In contrast, Group A was administered the silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet. Over a week, each group administered their designated drug once per day
DRUG	silodosin 8 mg capsule	The participants were assigned to groups A and B. Group B received the 8 mg silodosin capsule. In contrast, Group A was administered the silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet. Over a week, each group administered their designated drug once per day

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2024-03-20
• Last updated: 2024-03-20

Locations

1 site across 1 country: Egypt