Botox + HoLEP for Enlarged Prostate and Overactive Bladder

Recruiting at 2 trial locations

Overseen By Ellen Divoky

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Irina Jaeger

Must not be taking: Anticholinergics, Anticoagulants

Disqualifiers: Bladder/prostate cancer, Neurological diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to stop taking blood thinners (anticoagulation or antiplatelet inhibitors) 3 days before the procedure.

What data supports the effectiveness of the drug Botox for treating overactive bladder?

Research shows that Botox injections can help improve symptoms in people with overactive bladder, especially when other treatments haven't worked. It has been used successfully for conditions like neurogenic detrusor overactivity, which is a similar bladder issue. ^{1 2 3 4 5}

Is Botox safe for treating enlarged prostate and overactive bladder?

Botox injections for overactive bladder are generally safe, but they can cause side effects like urinary tract infections and increased urine left in the bladder after peeing. When used with prostate surgery (HoLEP), Botox did not increase complications and helped improve bladder control. ^{6 7 8 9 10}

How is the treatment of Botox + HoLEP for enlarged prostate and overactive bladder different from other treatments?

This treatment is unique because it combines Botox injections directly into the prostate with a surgical procedure called HoLEP, which removes excess prostate tissue. Botox helps relax muscles and reduce symptoms, offering a minimally invasive option compared to traditional surgery or oral medications. ^{9 11 12 13 14}

Research Team

Michael Zell

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

Men over 40 with severe urinary symptoms from an enlarged prostate (BPH) and overactive bladder, who haven't responded well to or can't take certain medications. They should be scheduled for HoLEP surgery, have a score of at least 17 on the IPSS and at least 7 on the OABSS. Men with a history of bladder/prostate cancer, pelvic radiotherapy, neurological diseases, active UTI, previous prostate surgeries or adverse reactions to Botox are excluded.

Inclusion Criteria

You have a high score on the International Prostate Symptom Score (IPSS).

My bladder symptoms score is 7 or higher.

I cannot use anticholinergic meds for my overactive bladder.

Exclusion Criteria

I cannot stop taking blood thinners 3 days before a procedure.

You have a history of needing to use a catheter to empty your bladder.

I have had radiation treatment in my pelvic area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo HoLEP surgery with or without intravesical Botox injections

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for changes in OABSS, PVR, IPSS, and maximum urinary flow rate at specified intervals

6 months

4 visits (in-person) at 2 weeks, 1 month, 3 months, and 6 months postoperatively

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Intravesical Botox injection

Trial Overview The trial is testing if giving Botox injections directly into the bladder during HoLEP surgery helps relieve urinary symptoms better than just having the HoLEP surgery alone. The study will compare symptom relief between two groups: those receiving both treatments simultaneously and those undergoing only HoLEP.

Participant Groups

Group I: Patients receiving HoLEP surgery + Intravesical Botox Injections Experimental Treatment 1 Intervention

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.

Group II: Patients receiving HoLEP surgery only Active Control 1 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.

Who Is Running the Clinical Trial?

Irina Jaeger

Lead Sponsor

Trials

1

Recruited

100+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Michael Zell, MD

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

Intradetrusor injections of Botulinum Toxin A (BoNTA) in 45 patients with neurogenic detrusor overactivity resulted in a good clinical response, with 68.9% of patients showing significant improvement after 6 weeks and 66.7% after 12 weeks.

The treatment led to a 48.2% increase in bladder volume and a 33.4% decrease in maximum intravesical pressure, with no reported side effects or deterioration in renal function, indicating both efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum Toxin A Intradetrusor Injection for Treating Neurogenic Detrusor Overactivity, A Single Centre Experience. Mosli, HA., Awad, MA., Rezk, MM., et al.[2015]

In a study of 174 patients receiving a single intravesical injection of 100U onabotulinumtoxinA for idiopathic detrusor overactivity, 79.3% reported successful outcomes at 3 months, indicating the treatment's efficacy.

Despite common adverse events like acute urinary retention and large postvoid residual, these did not negatively impact the long-term therapeutic success rates, suggesting that the treatment remains effective even in the presence of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficult Urination Does Not Affect the Successful Outcome after 100U OnabotulinumtoxinA Intravesical Injection in Patients with Idiopathic Detrusor Overactivity. Chen, YC., Kuo, HC.[2015]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Role of botulinum toxin-A in refractory idiopathic overactive bladder patients without detrusor overactivity. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

What a patient with refractory idiopathic detrusor overactivity should know about botulinum neurotoxin type a injection. [2010]

3. Australia pubmed.ncbi.nlm.nih.gov

Botulinum Toxin A Intradetrusor Injection for Treating Neurogenic Detrusor Overactivity, A Single Centre Experience. [2015]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Overactive Bladder Syndrome, Detrusor Overactivity and the Botulinum Toxin. [2019]

5. Egypt pubmed.ncbi.nlm.nih.gov

Predictors of response to intradetrusor botulinum toxin-A injections in patients with idiopathic overactive bladder. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Difficult Urination Does Not Affect the Successful Outcome after 100U OnabotulinumtoxinA Intravesical Injection in Patients with Idiopathic Detrusor Overactivity. [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot study of liposome-encapsulated onabotulinumtoxina for patients with overactive bladder: a single-center study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Intradetrusor OnabotulinumtoxinA Injections at the Time of Holmium Laser Enucleation of the Prostate for Men with Severe Storage Symptoms. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy of botulinum toxin-A injection versus oral anticholinergic medications following transurethral resection of the prostate to manage bladder outlet obstruction with overactive bladder: a prospective randomized clinical trial study. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse events of intravesical botulinum toxin a injections for idiopathic detrusor overactivity: risk factors and influence on treatment outcome. [2011]

11. England pubmed.ncbi.nlm.nih.gov

Sustained beneficial effects of intraprostatic botulinum toxin type A on lower urinary tract symptoms and quality of life in men with benign prostatic hyperplasia. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Is botulinum neurotoxin type A (BoNT-A) a novel therapy for lower urinary tract symptoms due to benign prostatic enlargement? A review of the literature. [2010]

13. Sweden pubmed.ncbi.nlm.nih.gov

Treatment of lower urinary tract symptoms: agents for intraprostatic injection. [2015]

14. England pubmed.ncbi.nlm.nih.gov

Intraprostatic Botulinum Toxin Type A injection in patients with benign prostatic enlargement: duration of the effect of a single treatment. [2021]