Botox + HoLEP for Enlarged Prostate and Overactive Bladder

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Botox injections (intravesical Botox injection) during HoLEP surgery for an enlarged prostate and overactive bladder can enhance recovery and symptom relief. The researchers aim to determine if this combination yields faster and better results than surgery alone. Men referred for HoLEP surgery due to persistent urinary issues, such as frequent urgency and nighttime bathroom trips, might be suitable candidates. Participants should have tried other medications without success. The study compares outcomes at various times after surgery to identify the best approach for treating these urinary symptoms. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for the treatment involving Botox and HoLEP?

Research shows that Botox injections into the bladder are generally safe for treating urinary problems. One study found that Botox was well-tolerated by both men and women with overactive bladder (OAB), including those with benign prostatic hyperplasia (BPH).

Some people might experience mild side effects, but serious problems are rare. This treatment has been used for other urinary issues and has shown good results. It can help reduce symptoms like frequent urination and bladder pain. These findings suggest that Botox injections could safely improve symptoms when used during prostate surgery, such as HoLEP. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Botox for treating an enlarged prostate and overactive bladder because it offers a unique approach compared to standard treatments like medications or surgeries such as TURP. Botox is traditionally known for reducing muscle activity, and when injected directly into the bladder (intravesical delivery), it can help relax bladder muscles, potentially reducing symptoms like frequent urination and urgency. This method is combined with HoLEP surgery, which already improves urinary flow by removing prostate tissue, and the Botox could enhance symptom relief further. This dual approach could lead to better outcomes and improve quality of life for patients more effectively than current options.

What evidence suggests that this trial's treatments could be effective for enlarged prostate and overactive bladder?

Research shows that Botox injections directly into the bladder can help manage urinary problems. Past studies have demonstrated that Botox reduces incontinence episodes and symptoms of an overactive bladder, especially when combined with bladder procedures like TURP (a surgery for prostate issues). For men with an enlarged prostate and overactive bladder, Botox has shown lasting effects in reducing prostate size and easing symptoms. One study found that combining Botox with bladder surgery significantly reduced symptoms weeks after treatment. In this trial, some participants will receive HoLEP surgery combined with Botox injections, while others will undergo HoLEP surgery only. Although less data exists on Botox specifically with HoLEP surgery, its success with similar procedures suggests it could be effective. ^{1 2 4 6 7}

Who Is on the Research Team?

Michael Zell

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10057732/

Intravesical Injection of Botulinum Toxin Type A in Men ... BTX-A has been shown to be effective in patients with and without urinary incontinence. Grishin et al. [11] divided enrolled patients, including ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05393921

The Combined Effect of Intravesical Botox Injections and ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5780293/

Botulinum toxin and benign prostatic hyperplasia - PMC [12] where a single 200 U injection of BoNT is found to have sustained effect on prostate volume reduction up to 18 months. This sustained effect observed over ...

4. icurology.org icurology.org/DOIx.php?id=10.4111/icu.2020.61.S1.S33

Clinical application of intravesical botulinum toxin type A ... Recent clinical trials on Botox for the treatment of IC/BPS have reported promising therapeutic effects, including reduced bladder pain.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405456920302571

Long-term Follow-up of Intravesical Onabotulinum Toxin-A ... The data of this retrospective, single-centre cohort suggest that BoNT-A treatment leads to lower CISC rates in male patients after prior desobstructive surgery ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2214388217300905

Review Botulinum toxin and benign prostatic hyperplasia In conclusion, use of BoNT-A on patients with LUTS secondary to BPH has been shown repeatedly to have a sustained effect to reduce prostate size and improve ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25538

Efficacy and safety of onabotulinumtoxinA for the treatment ... OnabotulinumtoxinA 100 U was efficacious and well tolerated in men and women with OAB, including in males with and without BPH.