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

Phase 4

Active, not recruiting

• Conditions: Underactive Bladder; TURP(transurethral Resection of Prostate); BPH (Benign Prostatic Hyperplasia)
• Interventions: Drug: Pyridostigmine oral tablet; Drug: Placebo

• Registration Number: NCT06753071
• Lead Sponsor: Menoufia University

Brief Summary

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

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 Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-07-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-21
• Last Update Submitted: 2024-12-21
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 66

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pyridostigmine group	Pyridostigmine oral tablet	this group will receive pyridostigmine 60 mg twice daily.
Control group	Placebo	This will receive placebo postoperatively.

Primary Outcome Measures

Name	Time	Method
Severity of lower urinary tract symptoms	1, 2 , 3 months postoperative	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.
Maximum urine flow rate	1, 2 , 3 months postoperative	Maximum urine flow rate will be assessed by flowmetry and measured by milliliter per second.
Post-void residual volume	1, 2 , 3 months postoperative	Post-void residual volume will be assessed by ultrasound assessment and measured by centimeter cubic.
Bladder contractility evaluation	1, 2 , 3 months postoperative	Bladder contractility will be assessed by urodynamic study. Contractility index is expressed in numbers as follows: strong \> 150, normal 100-150, and weak \< 100.
Bladder detrusor pressure assessment	1, 2 , 3 months postoperative	Bladder detrusor pressure will be assessed by urodynamic study and detrusor pressure measured by CmH2O.

Trial Locations

Locations (1)

Menoufia Faculty of Medicine; 🇪🇬 Shebin El-Kom, Menoufia, Egypt