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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06753071
Enrollment
66
Registered
2024-12-31
Start date
2024-04-01
Completion date
2025-01-01
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

BPH, TURP, underactive bladder, pyridostigmine

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.

Interventions

DRUGPyridostigmine oral tablet

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

DRUGPlacebo

Placebo oral tablet, twice daily, for 3 months

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Severity of lower urinary tract symptoms1, 2 , 3 months postoperativeSeverity 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 rate1, 2 , 3 months postoperativeMaximum urine flow rate will be assessed by flowmetry and measured by milliliter per second.
Post-void residual volume1, 2 , 3 months postoperativePost-void residual volume will be assessed by ultrasound assessment and measured by centimeter cubic.
Bladder contractility evaluation1, 2 , 3 months postoperativeBladder 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 assessment1, 2 , 3 months postoperativeBladder detrusor pressure will be assessed by urodynamic study and detrusor pressure measured by CmH2O.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026