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

NCT ID: NCT06753071

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-01-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pyridostigmine group

this group will receive pyridostigmine 60 mg twice daily.

Group Type: ACTIVE_COMPARATOR

Pyridostigmine oral tablet

Intervention Type: DRUG

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

Control group

This will receive placebo postoperatively.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral tablet, twice daily, for 3 months

Interventions

Pyridostigmine oral tablet

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

Intervention Type: DRUG

Placebo

Placebo oral tablet, twice daily, for 3 months

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Ammar Fathi Mohamed AlOrabi

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, Egypt

Countries

Egypt

Other Identifiers

Pyridostigmine therapy

Identifier Type: -

Identifier Source: org_study_id