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

The Efficacy of Pyridostigmine Therapy After Transurethral Resection of Prostate in Cases with Underactive Urinary Bladder: Prospective Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: BPH (Benign Prostatic Hyperplasia); Underactive Bladder; TURP(transurethral Resection of Prostate)
• Intervention / Treatment: Drug: Pyridostigmine oral tablet; Drug: Placebo

Detailed Description

Underactive bladder is a decrease in detrusor contraction and/or shortening of the contraction time, resulting in an incomplete and/or prolongation of the bladder emptying within the normal time frame. Prolonged bladder outlet obstruction due to prostatic enlargment one of the main causes of bladder hypocontractility. To make a diagnosis, it is necessary to perform a pressure-flow study. Decrease in maximum urine flow rate related to bladder outlet obstruction or poor contractility can be distinguished by pressure-flow study.

parasympathomimetics (cholinergic receptor stimulating agents) could be beneficial for patients with underactive bladder. However, no systematic review with meta-analysis addressing potential benefits or adverse effects exists. Pyridostigmine is a medication used to treat myasthenia gravis and underactive bladder as well.

Patients with underactive bladder after transurethral resection of prostate may still complain of recurrent attacks of obstructive lower urinary tract symptoms.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shebin El-Kom, Menoufia, Egypt, 32511
      • Menoufia Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pyridostigmine group; this group will receive pyridostigmine 60 mg twice daily.	Drug: Pyridostigmine oral tablet; Pyridostigmine oral tablet, 60 mg, twice daily, for 3 months
Placebo Comparator: Control group; This will receive placebo postoperatively.	Drug: Placebo; Placebo oral tablet, twice daily, for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: BPH; pyridostigmine; TURP; underactive bladder
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Bladder, Underactive; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Cholinergic Agents; Cholinesterase Inhibitors; Pyridostigmine Bromide
• Other Study ID Numbers: Pyridostigmine therapy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes