Underactive BladderPhase 4NCT06753071
The Efficacy of Pyridostigmine Therapy After Transurethral Resection of Prostate in Cases with Underactive Urinary Bladder.
A Phase 4 study testing Pyridostigmine oral tablet in people with Underactive Bladder and TURP(transurethral Resection of Prostate), run by Menoufia University at 1 site in Egypt.
Trial summary
The efficacy of pyridostigmine therapy after transurethral resection of prostate in cases with underactive urinary bladder Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Underactive Bladder, TURP(transurethral Resection of Prostate), BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- Pyridostigmine oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Pyridostigmine Therapy After Transurethral Resection of Prostate in Cases with Underactive Urinary Bladder: Prospective Randomized Trial
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.
- Conditions
- Underactive Bladder, TURP(transurethral Resection of Prostate), BPH (Benign Prostatic Hyperplasia)
- Being tested
- Pyridostigmine oral tablet, Placebo
- Keywords
- BPH, TURP, underactive bladder, pyridostigmine
- Medical subject headings
- Urinary Bladder, Underactive, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridostigmine oral tabletDrug
Pyridostigmine oral tablet, 60 mg, twice daily, for 3 months
PlaceboDrug
Placebo oral tablet, twice daily, for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Pyridostigmine group | Active comparator | this group will receive pyridostigmine 60 mg twice daily. Receives: Drug: Pyridostigmine oral tablet |
| Control group | Placebo comparator | This will receive placebo postoperatively. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 2 , 3 months postoperative
Maximum urine flow rate
Maximum urine flow rate will be assessed by flowmetry and measured by milliliter per second.
Measured: 1, 2 , 3 months postoperative
Post-void residual volume
Post-void residual volume will be assessed by ultrasound assessment and measured by centimeter cubic.
Measured: 1, 2 , 3 months postoperative
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.
Measured: 1, 2 , 3 months postoperative
Bladder detrusor pressure assessment
Bladder detrusor pressure will be assessed by urodynamic study and detrusor pressure measured by CmH2O.
Measured: 1, 2 , 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underactive BladderStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Fathi Mohamed AlOrabi, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753071
- Sponsor's protocol ID
- Pyridostigmine therapy
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pyridostigmine Therapy After Transurethral Resection of Prostate in Cases with Underactive Urinary Bladder: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06753071
- Acronym / sponsor ID
- Pyridostigmine therapy
- Conditions
- Underactive Bladder, TURP(transurethral Resection of Prostate), BPH (Benign Prostatic Hyperplasia)
- Keywords
- BPH, TURP, underactive bladder, pyridostigmine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridostigmine group | Active comparator | Drug: Pyridostigmine oral tabletthis group will receive pyridostigmine 60 mg twice daily. |
| Control group | Placebo comparator | Drug: PlaceboThis will receive placebo postoperatively. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyridostigmine oral tabletPyridostigmine oral tablet, 60 mg, twice daily, for 3 months | Drug | Pyridostigmine group |
| PlaceboPlacebo oral tablet, twice daily, for 3 months | Drug | Control group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Related trials for Underactive Bladder
RecruitingPhase 2
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Participants With Underactive Bladder (UAB)
Recruiting
Akyva First In Human
Underactive Bladder
Not yet recruiting
The Effect of Detrusor Underactivity in Determining Outcomes After Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia
Detrusor Underactivity, Transurethral Resection of the Prostate (TURP)
Recruiting
TURP Inpatient With Underactive Bladder With BOO
TURP Syndrome, Retention, Urinary
Not yet recruiting
EEP in Patients With Urodynamically Proven DU/DA
Lower Urinary Tract Symptoms, Lower Urinary Tract Obstructive Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pyridostigmine oral tablet in people with Underactive Bladder and TURP(transurethral Resection of Prostate), run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of lower urinary tract symptoms (time frame: 1, 2 , 3 months postoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.