The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention

NCT06319469 | Completed Phase 2 DMC

• 1 other identifier: FMBSUREC/06122022/Mohamed
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

group B

EXPERIMENTAL

8 mg silodosin

Drug: silodosin 8 mg capsule

group A

EXPERIMENTAL

silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet

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

Interventions

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

Also known as: Siloprostat 8 mg and pyriclonerve 60 mg

group A

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

Also known as: Siloprostat 8 mg

group B

Eligibility Criteria

• Age: 50 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Seuf University Hospital

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

silodosin; Tablets

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• ALSHAIMAA Ibrahim

  BENISEUF UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: February 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)