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NCT06319469 Clinical Trial

The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06319469
Other study ID # FMBSUREC/06122022/Mohamed
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 1, 2023
Est. completion date January 30, 2024

Study information
Verified date March 2024
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date January 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Egypt Beni-Seuf University Hospital Bani Suwayf

Sponsors (1)
Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary International Prostate Symptom Score (IPSS) 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. 3 MONTHS
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