The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention

Beni-Suef University

Status and phase

Completed

Phase 2

Conditions

Prostatic Hyperplasia

Treatments

Drug: silodosin 8 mg capsule

Drug: silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT06319469

FMBSUREC/06122022/Mohamed

Details and patient eligibility

About

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.

Full 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).

Enrollment

140 patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.