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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 belowSelect...
My bladder symptoms score is 7 or higher.
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I cannot use anticholinergic meds for my overactive bladder.
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I experience frequent urination, urgency, leakage, pain during urination, and nighttime urination.
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I am a man over 40 years old.
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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
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 moreSecondary 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.
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Who is running the clinical trial?
Irina JaegerLead Sponsor
University Hospitals Cleveland Medical CenterLead Sponsor
318 Previous Clinical Trials
339,985 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
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