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CompletedNCT06753071Updated Mar 26, 2025

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

A Phase 4 interventional study of Pyridostigmine oral tablet and Placebo in Underactive Bladder, TURP(transurethral Resection of Prostate) and BPH (Benign Prostatic Hyperplasia), sponsored by Menoufia University. Completed at 1 site in Egypt. Open to male participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Menoufia University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 4 months ago, and no results have been posted to the registry.
  • Registered 8 months after the study started (first participant enrolled Apr 2024, registered Dec 2024).
Phase
Phase 4
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • BPH
  • TURP
  • underactive bladder
  • pyridostigmine
03

In context

Urinary Bladder, Underactive

31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.

This study's enrollment of 66 is close to the median of 66 across 21 interventional studies indexed under Urinary Bladder, Underactive.

Browse Urinary Bladder, Underactive studies →

Lead sponsor

Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    Pyridostigmine group

    this group will receive pyridostigmine 60 mg twice daily.

    Drug: Pyridostigmine oral tablet

  • Placebo comparator
    Control group

    This will receive placebo postoperatively.

    Drug: Placebo

Interventions

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

  • DrugPlacebo

    Placebo oral tablet, twice daily, for 3 months

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1, 2 , 3 months postoperative

  2. Maximum urine flow rate

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

    Time frame: 1, 2 , 3 months postoperative

  3. Post-void residual volume

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

    Time frame: 1, 2 , 3 months postoperative

  4. 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.

    Time frame: 1, 2 , 3 months postoperative

  5. Bladder detrusor pressure assessment

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

    Time frame: 1, 2 , 3 months postoperative

07

Study locations

1 site
  • Menoufia Faculty of Medicine
    Shebin El-Kom, Menoufia 32511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06753071
Responsible party
Ammar Fathi Mohamed AlOrabi (Doctor, Menoufia University) — Principal investigator
First posted
Dec 31, 2024
Start date
Apr 1, 2024
Primary completion
Jul 1, 2024
Completion
Jan 1, 2025
Last update
Mar 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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