Botox + HoLEP for Enlarged Prostate and Overactive Bladder
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.12345Why 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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo HoLEP surgery with or without intravesical Botox injections
Postoperative Monitoring
Participants are monitored for changes in OABSS, PVR, IPSS, and maximum urinary flow rate at specified intervals
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Irina Jaeger
Lead Sponsor
University Hospitals Cleveland Medical Center
Lead Sponsor
Michael Zell, MD
Lead Sponsor
Published Research Related to This Trial
Citations
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 ...
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 ...
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 ...
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.
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 ...
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 ...
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.
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