BPHBPH BotoxNCT05910983
Prostate Enucleation With Intravesical Botox Injections in Treating BPH and Bladder Overactivity
A study testing Bipolar enucleation of the prostate (BipolEP) and Intravesical Botox injection in people with BPH and Intravesical Botox, run by Menoufia University.
Trial summary
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- BPH, Intravesical Botox, Bipolar Enucleation of the Prostate
- What is being tested?
- Bipolar enucleation of the prostate (BipolEP) and Intravesical Botox injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Dec 2025
- Phase
- Interventional
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males age > 40
- Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for Bipolar enucleation of the prostate ( BipolEP ) surgery
- Lower urinary tract symptoms (LUTS) of Overactive Bladder Syndrome (OABS) frequency - urgency - urge incontinence episodes - dysuria - nocturia and eligible for bladder botox injections
- International Prostate Symptom Score (IPSS) ≥ 17
- Overactive Bladder Symptom Score (OABSS) ≥ 7
- Participants have failed, are intolerant, or bad candidates for anticholinergic medication treatment for OAB
Who cannot join
- History of bladder/prostate cancer
- History of pelvic radiotherapy
- History of neurological diseases
- Presence of active Urinary Tract Infection (UTI)
- Previous Bladder Outlet Procedure (Transurethral resection of prostate (TURP) Transurethral Incision of Prostate (TUIP) - UroLift, etc..)
- History of adverse reaction to Botox injections
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- Post-void residual (PVR) greater than 300 ml
- History of clean intermittent catheterization
- Patients unable to stop anticoagulation of antiplatelet inhibitors 3 days prior to procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).
Read the detailed description
Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant negative impact on the patients' quality of life.
Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Thulium Laser Enucleation of the Prostate (ThuLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these.
A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints.
Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart).
The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated.
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation (BipolEP) surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).
The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively.
The investigators hypothesize that administering bladder botox injections during BipolEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a BipolEP surgery for their obstructive and irritative symptoms
- Conditions
- BPH, Intravesical Botox, Bipolar Enucleation of the Prostate, Overactive Bladder, Bladder Outlet Obstruction
- Being tested
- Bipolar enucleation of the prostate (BipolEP), Intravesical Botox injection
- Keywords
- Intravesical Botox, Bipolar enucleation of the prostate, BPH, Overactive Bladder, Bladder Outlet Obstruction
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar enucleation of the prostate (BipolEP)Procedure or surgery
Bipolar enucleation of the prostate (BipolEP)
Intravesical Botox injectionDrug
Intravesical botox injection given only in experimental group.100 units of Botox will be used and diluted in 10 mL of normal saline. 0.5 cc injections will be administered in 20 injection sites (trigone sparing).
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Bipolar enucleation of the prostate surgery only | Experimental | 50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for Bipolar enucleation of the prostate to treat their urinary symptoms. No Botox injections will be given. Receives: Procedure: Bipolar enucleation of the prostate (BipolEP) |
| Patients receiving Bipolar enucleation of the prostate surgery + Intravesical Botox Injections | Experimental | 50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for Bipolar enucleation of the prostate to treat their urinary symptoms. Botox injections will be given during the surgery. Receives: Procedure: Bipolar enucleation of the prostate (BipolEP); Drug: Intravesical Botox injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS)
Comparing the change in IPSS score between the two arms across time
Measured: IPSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Change in Overactive Bladder Symptoms Score (OABSS)
Comparing the change in OABSS score between the two arms across time
Measured: OABSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Change in Maximum Urinary Flow rate
Comparing the change in maximum urinary flow rate(mL/sec) between the two arms across time
Measured: Uroflowmetry will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Change in Post-Void Residual (PVR) Volume
Comparing the change in postvoid residual volume (mL) between the two arms across time
Measured: Postvoid residual volume (mL) will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Secondary outcomes (1)
Adverse events
Any adverse events in the context of readmissions, emergency department visits, and clinical visits will be recorded
Measured: Adverse events will be monitored throughout the entire study duration (6 months after the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start1 Jan 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a randomized clinical trial. The study team is interested in approaching and recruiting patients who were referred for Bipolar enucleation of the prostate surgery for their urinary symptoms and also eligible for intravesical Botox injections. This cohort of patients will be recruited and randomized into two groups: a control group that would undergo BipolEP procedure only, and an experimental group that will undergo BipolEP procedure combined with an intravesical Botox injection.This study will utilize a 1:1 randomization scheme to assign participants to either the control group or the experimental group. Participants will not be blinded to the procedure they are receiving. No one on the study team including those involved in data analysis will be blinded to the study arm assignment. The investigators plan to recruit a maximum of 50 participants in each arm. The study's intervention is whether Botox injections are added during the surgery or not.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Omar, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910983
- Sponsor's protocol ID
- BPH and Botox
- Acronym
- BPH Botox
- Status last verified
- May 2024
- First submitted
- 11 Jun 2023
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05910983
- Acronym / sponsor ID
- BPH Botox / BPH and Botox
- Conditions
- BPH, Intravesical Botox, Bipolar Enucleation of the Prostate, Overactive Bladder, Bladder Outlet Obstruction
- Keywords
- Intravesical Botox, Bipolar enucleation of the prostate, BPH, Overactive Bladder, Bladder Outlet Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Jun 2023 (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 aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).
Detailed description
Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant negative impact on the patients' quality of life.
Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Thulium Laser Enucleation of the Prostate (ThuLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these.
A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints.
Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart).
The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated.
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation (BipolEP) surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).
The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively.
The investigators hypothesize that administering bladder botox injections during BipolEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a BipolEP surgery for their obstructive and irritative symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be a randomized clinical trial. The study team is interested in approaching and recruiting patients who were referred for Bipolar enucleation of the prostate surgery for their urinary symptoms and also eligible for intravesical Botox injections. This cohort of patients will be recruited and randomized into two groups: a control group that would undergo BipolEP procedure only, and an experimental group that will undergo BipolEP procedure combined with an intravesical Botox injection.This study will utilize a 1:1 randomization scheme to assign participants to either the control group or the experimental group. Participants will not be blinded to the procedure they are receiving. No one on the study team including those involved in data analysis will be blinded to the study arm assignment. The investigators plan to recruit a maximum of 50 participants in each arm. The study's intervention is whether Botox injections are added during the surgery or not.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Bipolar enucleation of the prostate surgery only | Experimental | Procedure: Bipolar enucleation of the prostate (BipolEP)50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for Bipolar enucleation of the prostate to treat their urinary symptoms. No Botox injections will be given. |
| Patients receiving Bipolar enucleation of the prostate surgery + Intravesical Botox Injections | Experimental | Procedure: Bipolar enucleation of the prostate (BipolEP), Drug: Intravesical Botox injection50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for Bipolar enucleation of the prostate to treat their urinary symptoms. Botox injections will be given during the surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males age > 40
- Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for Bipolar enucleation of the prostate ( BipolEP ) surgery
- Lower urinary tract symptoms (LUTS) of Overactive Bladder Syndrome (OABS) frequency - urgency - urge incontinence episodes - dysuria - nocturia and eligible for bladder botox injections
- International Prostate Symptom Score (IPSS) ≥ 17
- Overactive Bladder Symptom Score (OABSS) ≥ 7
Key exclusion criteria (9 listed)
- History of bladder/prostate cancer
- History of pelvic radiotherapy
- History of neurological diseases
- Presence of active Urinary Tract Infection (UTI)
- Previous Bladder Outlet Procedure (Transurethral resection of prostate (TURP) Transurethral Incision of Prostate (TUIP) - UroLift, etc..)
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 |
|---|---|---|
| Bipolar enucleation of the prostate (BipolEP)Bipolar enucleation of the prostate (BipolEP) | Procedure or surgery | Patients receiving Bipolar enucleation of the prostate surgery + Intravesical Botox Injections, Patients receiving Bipolar enucleation of the prostate surgery only |
| Intravesical Botox injectionIntravesical botox injection given only in experimental group.100 units of Botox will be used and diluted in 10 mL of normal saline. 0.5 cc injections will be administered in 20 injection sites (trigone sparing). | Drug | Patients receiving Bipolar enucleation of the prostate surgery + Intravesical Botox Injections |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: IPSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Comparing the change in IPSS score between the two arms across time
Change in Overactive Bladder Symptoms Score (OABSS)
Time frame: OABSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Comparing the change in OABSS score between the two arms across time
Change in Maximum Urinary Flow rate
Time frame: Uroflowmetry will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Comparing the change in maximum urinary flow rate(mL/sec) between the two arms across time
Change in Post-Void Residual (PVR) Volume
Time frame: Postvoid residual volume (mL) will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively
Comparing the change in postvoid residual volume (mL) between the two arms across time
1 secondary outcome
Adverse events
Time frame: Adverse events will be monitored throughout the entire study duration (6 months after the surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar enucleation of the prostate (BipolEP) and Intravesical Botox injection in people with BPH and Intravesical Botox, run by Menoufia University.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Kamal Omar, MD (+20 106 694 9454, Kimo_81eg@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: IPSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively). The study lists 4 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 17 May 2024.