The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention

Phase 2

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet; Drug: silodosin 8 mg capsule

• Registration Number: NCT06319469
• Lead Sponsor: Beni-Suef University

Brief 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).

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 140

Inclusion Criteria

• Patients with a retention volume of less than 1000 milliliters who were over 50 years old and going through their first episode of acute urine retention (AUR) due to benign prostatic hyperplasia (BPH) were included in this study

Exclusion Criteria

• The individuals who do not meet the eligibility requirements are those who have been diagnosed with an infection of the urinary tract, have repeatedly retained urine, have had unsuccessful trial voiding procedures in the past, have a retention volume of more than one liter, have had a history of prostatic or bladder neck surgery, have been diagnosed with prostate carcinoma, have experienced urethral stricture, have a neurogenic bladder, have been diagnosed with renal failure, or have been diagnosed with liver disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet	silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet
group B	silodosin 8 mg capsule	8 mg silodosin

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS)	3 MONTHS	t is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

Trial Locations

Locations (1)

Beni-Seuf University Hospital; 🇪🇬 Banī Suwayf, Egypt