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NCT Number: NCT06753071

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

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Key information

Conditions

Underactive Bladder BPH (Benign Prostatic Hyperplasia) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms TURP(Transurethral Resection of Prostate) Urinary Bladder Diseases Urinary Bladder, Underactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pyridostigmine oral tablet

Drug

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

Placebo

Drug

Placebo oral tablet, twice daily, for 3 months

Primary outcomes

  1. Severity of lower urinary tract symptoms

    Time frame: 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.

  2. Maximum urine flow rate

    Time frame: 1, 2 , 3 months postoperative

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

  3. Post-void residual volume

    Time frame: 1, 2 , 3 months postoperative

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

  4. Bladder contractility evaluation

    Time frame: 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.

  5. Bladder detrusor pressure assessment

    Time frame: 1, 2 , 3 months postoperative

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

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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