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Completed

NCT Number: NCT06319469

The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention

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.

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Key information

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Beni-Seuf University Hospital

Banī Suwayf, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet

Drug

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

Other names: Siloprostat 8 mg and pyriclonerve 60 mg

silodosin 8 mg capsule

Drug

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

Other names: Siloprostat 8 mg

Primary outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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