What is the mechanism of action of this treatment?

The most common treatments for urinary incontinence, such as OnabotulinumtoxinA, work by inhibiting the release of acetylcholine to reduce muscle overactivity in the bladder. This is crucial for patients because it directly addresses the involuntary contractions of the detrusor muscle that cause incontinence. Other treatments, like antimuscarinics, block muscarinic receptors to reduce bladder muscle contractions, and beta-3 agonists like mirabegron relax the bladder muscle to increase its storage capacity. These mechanisms help manage symptoms, improve quality of life, and reduce the frequency and urgency of urination.

What side effects are associated with this type of intervention?

Common treatments for urinary incontinence that inhibit acetylcholine release, such as OnabotulinumtoxinA injections, can have several side effects. These include transient and mild complications like urinary tract infections, difficulty urinating, and the need for catheterization. Anticholinergic medications, another common treatment, can cause dry mouth, constipation, blurred vision, and cognitive dysfunction, particularly in older adults. Both treatments aim to reduce muscle overactivity but come with potential adverse effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

OnabotulinumtoxinA (Botox) has been FDA-approved for the treatment of urinary incontinence, particularly in cases of overactive bladder and neurogenic detrusor overactivity. This treatment works by inhibiting the release of acetylcholine, thereby reducing muscle overactivity in the bladder. Other FDA-approved treatments for urinary incontinence include anticholinergic medications like oxybutynin and tolterodine, which also target bladder muscle activity by blocking acetylcholine receptors. Additionally, beta-3 adrenergic agonists such as mirabegron have been approved to relax the bladder muscle and increase storage capacity.

What other types of research exist?

Promising novel alternatives to OnabotulinumtoxinA for urinary incontinence include: 1) Sacral neuromodulation, which involves electrical stimulation of sacral nerves to improve bladder control. 2) Percutaneous tibial nerve stimulation (PTNS), a minimally invasive procedure that stimulates the tibial nerve to reduce overactive bladder symptoms. 3) Mirabegron, a beta-3 adrenergic agonist that relaxes the bladder muscle to increase storage capacity. 4) Desmopressin, particularly in formulations designed to reduce nocturia by decreasing urine production at night.

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Neurotoxin

Botox for Overactive Bladder

Phase 2 & 3

Recruiting

Led By Amy Krambeck, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Males 18-89 undergoing HoLEP

Be older than 18 years old

Must not have

Active urinary tract infection

Anticipated need for perineal urethrostomy at the time of HoLEP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if injecting Botox into the bladder during prostate surgery can help men with overactive bladder symptoms. The goal is to see if this treatment can reduce the urgent need to urinate and accidents by relaxing the bladder muscle. Botox has been studied for its effectiveness and safety in treating lower urinary tract symptoms and overactive bladder.

Who is the study for?

This trial is for men aged 18-89 who are undergoing HoLEP surgery and have overactive bladder symptoms, including frequent urination, nighttime urination, urgency, or urge-related incontinence. Participants must be able to understand and fill out questionnaires. Men with allergies to Botox, other surgeries at the same time as HoLEP, prior pelvic radiation or bladder cancer history, decision-making impairments, or active urinary infections cannot join.

What is being tested?

The study is testing the safety and effectiveness of injecting OnabotulinumtoxinA (Botox) into the bladder muscle during a prostate surgery called HoLEP in men with overactive bladder symptoms. It's a multi-center study where participants are randomly chosen to receive either Botox injections or not during their procedure.

What are the potential side effects?

Possible side effects from OnabotulinumtoxinA injections may include pain at injection site, urinary retention requiring catheterization, blood in urine post-procedure, increased risk of urinary tract infections and general weakness.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a man aged 18-89 scheduled for HoLEP surgery.

Exclusion Criteria

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

Select...

I currently have a urinary tract infection.

Select...

I might need a surgical opening in the perineum during my prostate surgery.

Select...

I am having a procedure for kidney stones or another surgery at the same time as my HoLEP.

Select...

I am unable to make my own medical decisions.

Select...

I have had radiation in my pelvic area or have a history of bladder cancer, with or without BCG therapy.

Select...

I am allergic to Botox injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.

Secondary study objectives

Difference in efficacy endpoints (3-month clinic/telephone follow-up)

Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)

Difference in safety/ adverse effects

Side effects data

From 2014 Phase 4 trial • 250 Patients • NCT02096081

Headache

Facial Asymmetry

Human ehrlichiosis

100%

80%

60%

40%

20%

Study treatment Arm

IncobotulinumtoxinA

OnabotulinumtoxinA

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intra-detrusor OnabotulinumtoxinA InjectionExperimental Treatment1 Intervention

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.

Group II: No intra-detrusor OnabotulinumtoxinA InjectionActive Control1 Intervention

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OnabotulinumtoxinA

2014

Completed Phase 4

~3920

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for urinary incontinence, such as OnabotulinumtoxinA, work by inhibiting the release of acetylcholine to reduce muscle overactivity in the bladder. This is crucial for patients because it directly addresses the involuntary contractions of the detrusor muscle that cause incontinence. Other treatments, like antimuscarinics, block muscarinic receptors to reduce bladder muscle contractions, and beta-3 agonists like mirabegron relax the bladder muscle to increase its storage capacity. These mechanisms help manage symptoms, improve quality of life, and reduce the frequency and urgency of urination.

OnabotulinumtoxinA (Botox(®)): a review of its use in the treatment of urinary incontinence in patients with multiple sclerosis or subcervical spinal cord injury.