← Back to Search

Neurotoxin

Botox + HoLEP for Enlarged Prostate and Overactive Bladder

Phase 4

Waitlist Available

Led By Amihay Nevo, MD

Research Sponsored by Irina Jaeger

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Overactive Bladder Symptom Score (OABSS) ≥ 7

Participants have failed, are intolerant, or bad candidates for anticholinergic medication treatment for OAB

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial will compare the postoperative outcome of intravesical Botox injections during HoLEP surgery versus HoLEP surgery only in patients with BOO and OAB.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort at injection site within the bladder, possible blood in urine temporarily after procedure, increased risk of UTI post-treatment, difficulty urinating requiring temporary catheterization and rare allergic reactions to Botox.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My bladder symptoms score is 7 or higher.

Select...

I cannot use anticholinergic meds for my overactive bladder.

Select...

I experience frequent urination, urgency, leakage, pain during urination, and nighttime urination.

Select...

I am a man over 40 years old.

Select...

I have been diagnosed with BPH and referred for HoLEP surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in International Prostate Symptom Score (IPSS)

Change in Maximum Urinary Flow rate

Change in Overactive Bladder Symptoms Score (OABSS)

+1 more

Secondary outcome measures

Adverse events

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patients receiving HoLEP surgery + Intravesical Botox InjectionsExperimental Treatment1 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 onlyActive Control1 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Irina JaegerLead Sponsor

University Hospitals Cleveland Medical CenterLead Sponsor

317 Previous Clinical Trials

340,157 Total Patients Enrolled

Michael Zell, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any known adverse reactions associated with Intravesical Botox injection?

"There is extensive evidence and approval of Intravesical Botox injection's safety, thus it earned a score of 3."

Answered by AI

Is this experiment open for enrollment of new participants?

"The most recent update to the clinicaltrials.gov page for this trial has been on May 20, 2022 indicating that it is not presently accepting patients. Despite that there are still 201 other trials actively recruiting participants at the moment of writing."

Answered by AI

Recent research and studies

World Journal of UrologyJournal

Super Early Detailed Assessment of Lower Urinary Tract Symptoms After Holmium Laser Enucleation of the Prostate (holep): A Prospective Study

Ahyai, Sascha A., Irina Marik, Tim A. Ludwig, Andreas Becker, Saman Asdjodi, Luis Kluth, Felix Chun, Margit Fisch, and Marianne Schmid. 2020. “Super Early Detailed Assessment of Lower Urinary Tract Symptoms After Holmium Laser Enucleation of the Prostate (holep): A Prospective Study”. World Journal of Urology. Springer Science and Business Media LLC. doi:10.1007/s00345-020-03126-x.

International braz j urolJournal

Botulinum Toxin Injection: A Review of Injection Principles and Protocols

Rapp, David E., Alvaro Lucioni, and Gregory T. Bales. 2007. “Botulinum Toxin Injection: A Review of Injection Principles and Protocols”. International Braz J Urol. FapUNIFESP (SciELO). doi:10.1590/s1677-55382007000200002.

Clinical Pharmacology: Advances and ApplicationsJournal

<p>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</p>

Allameh, Farzad, Abbas Basiri, Mohammadreza Razzaghi, Amirreza Abedi, Morteza Fallah-karkan, Saleh Ghiasy, Seyed Mohammad Hosseininia, and Saeed Montazeri. 2020. “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”. Clinical Pharmacology: Advances and Applications. Informa UK Limited. doi:10.2147/cpaa.s256051.

Nature Clinical Practice UrologyJournal