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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

Must not have

History of pelvic radiotherapy

History of bladder/prostate cancer

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

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation treatment in my pelvic area.

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I have a history of bladder or prostate cancer.

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I have had a procedure done to improve urine flow from my bladder.

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I currently have a urinary tract infection.

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I have a history of neurological diseases.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in International Prostate Symptom Score (IPSS)

Change in Maximum Urinary Flow rate

Change in Overactive Bladder Symptoms Score (OABSS)

+1 more

Secondary study objectives

Adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 / 10Eligibility criteria met