The Efficacy of Pyridostigmine Therapy After Transurethral Resection of Prostate in Cases with Underactive Urinary Bladder.

NCT06753071 | Completed Phase 4 FDA Drug

• 1 other identifier: Pyridostigmine therapy
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of pyridostigmine therapy after transurethral resection of prostate in cases with underactive urinary bladder

Conditions

Underactive Bladder; TURP(transurethral Resection of Prostate); BPH (Benign Prostatic Hyperplasia)

Keywords

BPH; TURP; underactive bladder; pyridostigmine

Outcome Measures

Primary Outcomes (5)

• Severity of lower urinary tract symptoms

  Severity of lower urinary tract symptoms will be assessed by International Prostate Symptom Score (IPSS) and expressed in number. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

  1, 2 , 3 months postoperative

• Maximum urine flow rate

  Maximum urine flow rate will be assessed by flowmetry and measured by milliliter per second.

  1, 2 , 3 months postoperative

• Post-void residual volume

  Post-void residual volume will be assessed by ultrasound assessment and measured by centimeter cubic.

  1, 2 , 3 months postoperative

• Bladder contractility evaluation

  Bladder contractility will be assessed by urodynamic study. Contractility index is expressed in numbers as follows: strong \> 150, normal 100-150, and weak \< 100.

  1, 2 , 3 months postoperative

• Bladder detrusor pressure assessment

  Bladder detrusor pressure will be assessed by urodynamic study and detrusor pressure measured by CmH2O.

  1, 2 , 3 months postoperative

Study Arms (2)

Pyridostigmine group

ACTIVE COMPARATOR

this group will receive pyridostigmine 60 mg twice daily.

Drug: Pyridostigmine oral tablet

Control group

PLACEBO COMPARATOR

This will receive placebo postoperatively.

Drug: Placebo

Interventions

Pyridostigmine oral tablet DRUG

Pyridostigmine oral tablet, 60 mg, twice daily, for 3 months

Pyridostigmine group

Placebo DRUG

Placebo oral tablet, twice daily, for 3 months

Control group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are not younger than 45 or older than 75 years.
• Patients with benign prostatic hyperplasia who are eligible for transurethral resection of prostate.
• Patients who has decreased bladder contractility confirmed by urodynamic study (pressure flow study) and plotted on international continence society (ICS) nomogram.

You may not qualify if:

• Patients younger than 45 or older than 75 years.
• Patients who have diabetes.
• Patients with a history of neurological diseases.
• patients with a previous history of pelvic surgery.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Underactive; Prostatic Hyperplasia

Interventions

Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 31, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

EG (1)