Benign Prostatic HyperplasiaPhase 4NCT05393921
The Combined Effect of Intravesical Botox Injections and HoLEP Surgery in Treating Benign Prostatic Hyperplasia and Overactive Bladder
A Phase 4 study testing Intravesical Botox injection in people with Benign Prostatic Hyperplasia and Overactive Bladder, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Overactive Bladder
- What is being tested?
- Intravesical Botox injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2026to Jul 2027
- 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 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 HoLEP 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
Show all 9Show fewer
- 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
3 sites in 1 country.
United States3 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
UH Brainard Medical Bldg
Lyndhurst, Ohio, 44124
UH Regional Hospitals - Richmond Campus
Richmond Heights, Ohio, 44143
About this study
Official title: The Clinical Efficacy of Intravesical Botox Injections When Combined With HoLEP Surgery in Patients With Benign Prostatic Hyperplasia and Overactive Bladder
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), Holmium Laser Enucleation of the Prostate (HoLEP), 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.
Read more
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 HoLEP 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 HoLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a HoLEP surgery for their obstructive and irritative symptoms.
- Conditions
- Benign Prostatic Hyperplasia, Overactive Bladder
- Being tested
- Intravesical Botox injection
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 HoLEP surgery only | No intervention | 50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for HoLEP to treat their urinary symptoms. No Botox injections will be given. |
| Patients receiving HoLEP surgery + Intravesical Botox Injections | Experimental | 50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for HoLEP to treat their urinary symptoms. Botox injections will be given during the surgery. Receives: 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 posted26 May 2022
- Study start1 Jun 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: Lack of interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Model description
- This study will be a randomized clinical trial. The study team is interested in approaching and recruiting patients who were referred for HoLEP 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 HoLEP procedure only, and an experimental group that will undergo HoLEP 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zell, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393921
- Sponsor's protocol ID
- STUDY20220495
- Status last verified
- Aug 2025
- First submitted
- 20 May 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
Antunes AA, Srougi M, Coelho RF, de Campos Freire G. Botulinum toxin for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Nat Clin Pract Urol. 2007 Mar;4(3):155-60. doi: 10.1038/ncpuro0735.
PubMed 17347660Ahyai SA, Marik I, Ludwig TA, Becker A, Asdjodi S, Kluth L, Chun F, Fisch M, Schmid M. Super early detailed assessment of lower urinary tract symptoms after holmium laser enucleation of the prostate (HoLEP): a prospective study. World J Urol. 2020 Dec;38(12):3207-3217. doi: 10.1007/s00345-020-03126-x. Epub 2020 Feb 21.
PubMed 32086571Rapp DE, Lucioni A, Bales GT. Botulinum toxin injection: a review of injection principles and protocols. Int Braz J Urol. 2007 Mar-Apr;33(2):132-41. doi: 10.1590/s1677-55382007000200002.
PubMed 17488531Allameh F, Basiri A, Razzaghi M, Abedi AR, Fallah-Karkan M, Ghiasy S, Hosseininia SM, Montazeri S. Clinical Efficacy of Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin - A Injection to Treat Benign Prostatic Hyperplasia with Overactive Bladder: A Case-Control Study. Clin Pharmacol. 2020 Jun 26;12:75-81. doi: 10.2147/CPAA.S256051. eCollection 2020.
PubMed 32617023Fusco F, Creta M, De Nunzio C, Iacovelli V, Mangiapia F, Li Marzi V, Finazzi Agro E. Progressive bladder remodeling due to bladder outlet obstruction: a systematic review of morphological and molecular evidences in humans. BMC Urol. 2018 Mar 9;18(1):15. doi: 10.1186/s12894-018-0329-4.
PubMed 29519236
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Intravesical Botox Injections When Combined With HoLEP Surgery in Patients With Benign Prostatic Hyperplasia and Overactive Bladder
- ClinicalTrials.gov ID
- NCT05393921
- Acronym / sponsor ID
- STUDY20220495
- Conditions
- Benign Prostatic Hyperplasia, Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 May 2022 (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.
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), Holmium Laser Enucleation of the Prostate (HoLEP), 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 HoLEP 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 HoLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a HoLEP 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 HoLEP 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 HoLEP procedure only, and an experimental group that will undergo HoLEP 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 HoLEP surgery only | No intervention | –50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for HoLEP to treat their urinary symptoms. No Botox injections will be given. |
| Patients receiving HoLEP surgery + Intravesical Botox Injections | Experimental | Drug: Intravesical Botox injection50 patients diagnosed with benign prostatic hyperplasia and overactive bladder and referred for HoLEP 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 HoLEP 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 |
|---|---|---|
| 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 HoLEP 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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 17347660Antunes AA, Srougi M, Coelho RF, de Campos Freire G. Botulinum toxin for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Nat Clin Pract Urol. 2007 Mar;4(3):155-60. doi: 10.1038/ncpuro0735.
- Background: PubMed 32086571Ahyai SA, Marik I, Ludwig TA, Becker A, Asdjodi S, Kluth L, Chun F, Fisch M, Schmid M. Super early detailed assessment of lower urinary tract symptoms after holmium laser enucleation of the prostate (HoLEP): a prospective study. World J Urol. 2020 Dec;38(12):3207-3217. doi: 10.1007/s00345-020-03126-x. Epub 2020 Feb 21.
- Background: PubMed 17488531Rapp DE, Lucioni A, Bales GT. Botulinum toxin injection: a review of injection principles and protocols. Int Braz J Urol. 2007 Mar-Apr;33(2):132-41. doi: 10.1590/s1677-55382007000200002.
- Background: PubMed 32617023Allameh F, Basiri A, Razzaghi M, Abedi AR, Fallah-Karkan M, Ghiasy S, Hosseininia SM, Montazeri S. Clinical Efficacy of Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin - A Injection to Treat Benign Prostatic Hyperplasia with Overactive Bladder: A Case-Control Study. Clin Pharmacol. 2020 Jun 26;12:75-81. doi: 10.2147/CPAA.S256051. eCollection 2020.
- Background: PubMed 29519236Fusco F, Creta M, De Nunzio C, Iacovelli V, Mangiapia F, Li Marzi V, Finazzi Agro E. Progressive bladder remodeling due to bladder outlet obstruction: a systematic review of morphological and molecular evidences in humans. BMC Urol. 2018 Mar 9;18(1):15. doi: 10.1186/s12894-018-0329-4.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
Michael Zell, MD principal investigator
University Hospitals Cleveland Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravesical Botox injection in people with Benign Prostatic Hyperplasia and Overactive Bladder, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
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: withdrawn, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
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?
On the ClinicalTrials.gov record for NCT05393921, which also lists 5 linked publications.
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 5 Sep 2025.