Botox for Overactive Bladder

Overseen By Alyssa McDonald

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Northwestern University

Disqualifiers: Allergy to OnabotulinumtoxinA, Bladder cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (at time of HoLEP)

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Botox safe for treating overactive bladder?

Botox (OnabotulinumtoxinA) has been shown to be generally safe for treating overactive bladder, but some people may experience side effects like incomplete bladder emptying and urinary tract infections. ^{1 2 3 4 5}

How is the drug Botox different from other treatments for overactive bladder?

Botox (onabotulinumtoxinA) is unique because it is injected directly into the bladder muscle, helping to relax it and reduce overactive bladder symptoms. This is different from other treatments that are often oral medications or lifestyle changes. ^{6 7 8 9 10}

Research Team

Amy Krambeck, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

Willing to sign the Informed Consent Form

Able to read, understand, and complete patient questionnaires

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

Exclusion Criteria

I currently have a urinary tract infection.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intra-detrusor OnabotulinumtoxinA injections are administered at the time of HoLEP

Immediate (at time of HoLEP)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of urinary retention, hematuria, and other complications

3 months

Clinic/telephone follow-up

Extended Follow-up

Long-term monitoring of symptom resolution and efficacy endpoints through patient surveys and clinical assessments

6-12 months

Treatment Details

Interventions

• OnabotulinumtoxinA

Trial Overview 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.

Participant Groups

Group I: Intra-detrusor OnabotulinumtoxinA Injection Experimental Treatment 1 Intervention

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

Group II: No intra-detrusor OnabotulinumtoxinA Injection Active Control 1 Intervention

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

OnabotulinumtoxinA is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Urinary incontinence
• Facial wrinkles
• Cervical dystonia
• Upper limb spasticity
• Lower limb spasticity

Approved in European Union as Botox for:

• Blepharospasm
• Strabismus
• Axillary hyperhidrosis
• Cervical dystonia
• Upper limb spasticity
• Lower limb spasticity
• Overactive bladder
• Urinary incontinence
• Facial wrinkles

Approved in Canada as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Urinary incontinence
• Facial wrinkles
• Cervical dystonia
• Upper limb spasticity
• Lower limb spasticity

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Findings from Research

Botulinum toxin-A significantly improves symptoms of idiopathic overactive bladder (OAB), including reduced urinary frequency and incontinence episodes, based on a review of 12 randomized controlled trials involving 1,020 participants.

While effective, botulinum toxin-A is associated with a higher risk of urinary retention and urinary tract infections compared to placebo, suggesting that lower doses may provide a better balance of benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin-A injections for idiopathic overactive bladder: a systematic review and meta-analysis. Cui, Y., Wang, L., Liu, L., et al.[2022]

In a study of 686 Korean patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO) or overactive bladder (OAB), onabotulinumtoxinA significantly reduced UI symptoms, with 64.9% of NDO patients and 47.3% of OAB patients showing a meaningful improvement of over 5 points on the ICIQ-SF scale.

The treatment was found to be safe, with only a small percentage of patients experiencing adverse drug reactions (5.6% for NDO and 3.2% for OAB), primarily related to urinary tract issues, indicating a favorable risk-benefit profile for onabotulinumtoxinA in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Korean Postmarketing Study Assessing the Effectiveness of OnabotulinumtoxinA for the Treatment of Neurogenic Detrusor Overactivity or Idiopathic Overactive Bladder Using a Validated Patient-Reported Outcome Measure. Ko, KJ., Jenkins, B., Patel, A., et al.[2020]

In a study of 290 patients receiving intravesical onabotulinumtoxinA (BoNT-A) for overactive bladder, common adverse events included acute urinary retention (8.3%) and urinary tract infections (15.2%) within 3 months post-treatment.

Predictive factors for these adverse events included being male, older than 61 years, having a low maximum flow rate (Qmax), high post-void residual (PVR) volume, and low voiding efficiency, indicating that certain patient characteristics can help identify those at higher risk for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors of adverse events after intravesical suburothelial onabotulinumtoxina injections for overactive bladder syndrome-A real-life practice of 290 cases in a single center. Jiang, YH., Ong, HL., Kuo, HC.[2018]

In a systematic review of 11 randomized controlled trials involving 1008 patients, onabotulinumtoxinA (BOTOX) was found to be significantly more effective than placebo in improving bladder control, symptoms, and quality of life for patients with refractory idiopathic overactive bladder (iOAB).

The treatment was well tolerated, with manageable adverse events such as urinary retention and infections, which did not negatively impact the patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Idiopathic overactive bladder and BOTOX(®): Literature review]. Gamé, X., Karsenty, G., Ruffion, A., et al.[2018]

In a study of 278 adults receiving onabotulinumtoxin A (BTX-A) for overactive bladder, 35% of men and 17% of women experienced incomplete emptying, with men having 2.4 times higher odds than women.

The study found that 17% of men and 23.5% of women developed urinary tract infections (UTIs) post-injection, with a history of prior UTIs being the strongest predictor for developing a UTI after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incomplete bladder emptying and urinary tract infections after botulinum toxin injection for overactive bladder: Multi-institutional collaboration from the SUFU research network. Reynolds, WS., Suskind, AM., Anger, JT., et al.[2023]

In a study of 102 women, both those with idiopathic overactive bladder (OAB) and those with de novo OAB after midurethral sling surgery showed significant improvement in symptoms after receiving onabotulinumtoxinA injections, with similar rates of being completely dry (41.5% vs. 38.8%).

The treatment led to a notable reduction in daily voids and incontinence episodes for both groups, with urinary retention occurring in only four patients, indicating that the safety profile of onabotulinumtoxinA is acceptable even in women who have undergone previous surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of botulinum toxin injection in the treatment of de novo OAB symptoms following midurethral sling surgery. Miotla, P., Futyma, K., Cartwright, R., et al.[2018]

In a pilot study involving 28 patients with refractory overactive bladder (OAB) after surgery for benign prostatic hyperplasia (BPH), onabotulinumtoxinA (BOTOX) showed significant improvements in quality of life and lower urinary incontinence scores at 6 and 9 months post-treatment.

Patients receiving onabotulinumtoxinA experienced a reduction in urinary frequency from 11 to 8 voids per day, while the placebo group showed no change, indicating potential efficacy in managing OAB symptoms, although larger studies are needed for confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo controlled pilot study of intradetrusor injections of onabotulinumtoxinA for the treatment of refractory overactive bladder persisting following surgical management of benign prostatic hyperplasia. Chughtai, B., Dunphy, C., Lee, R., et al.[2018]

In a study involving 97 patients across six urogynecology centers, OnabotulinumtoxinA (Botox) was primarily used as a second-line treatment for idiopathic overactive bladder after previous therapies like tibial or sacral neuromodulation failed, with 70% of first injections adhering to marketing authorization guidelines.

The study highlighted significant variability in diagnostic and treatment practices among centers, indicating a need for greater standardization in the use of Botox for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Botulinium toxin and idiopathic overactive bladder: Multicentric contempory management in Bourgogne]. Schneider, A., Tourlonias, B., Cormier, L., et al.[2019]

In a study of 208 women with idiopathic overactive bladder (OAB) treated with 100 U of Botox, older and multiparous women were found to be at a higher risk for urinary retention, particularly those requiring clean intermittent self-catheterization (CISC).

The risk of urinary retention significantly decreased by 2 weeks post-injection, indicating that close monitoring during this period is crucial for OAB patients after receiving Botox treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary retention in female OAB after intravesical Botox injection: who is really at risk? Miotla, P., Cartwright, R., Skorupska, K., et al.[2018]

In a study of 207 patients with non-neurogenic overactive bladder, both onabotulinumtoxinA (Botox) and abobotulinumtoxinA (Dysport) showed similar effectiveness in reducing symptoms like daytime frequency and incontinence episodes.

However, abobotulinumtoxinA was associated with a significantly higher rate of urinary retention requiring intermittent self-catheterization (42% vs 23%), indicating that these two treatments are not interchangeable at the doses used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A for the treatment of non-neurogenic overactive bladder: does using onabotulinumtoxinA (Botox(®) ) or abobotulinumtoxinA (Dysport(®) ) make a difference? Ravindra, P., Jackson, BL., Parkinson, RJ.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Botulinum toxin-A injections for idiopathic overactive bladder: a systematic review and meta-analysis. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

A Korean Postmarketing Study Assessing the Effectiveness of OnabotulinumtoxinA for the Treatment of Neurogenic Detrusor Overactivity or Idiopathic Overactive Bladder Using a Validated Patient-Reported Outcome Measure. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Predictive factors of adverse events after intravesical suburothelial onabotulinumtoxina injections for overactive bladder syndrome-A real-life practice of 290 cases in a single center. [2018]

4. France pubmed.ncbi.nlm.nih.gov

[Idiopathic overactive bladder and BOTOX(®): Literature review]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Incomplete bladder emptying and urinary tract infections after botulinum toxin injection for overactive bladder: Multi-institutional collaboration from the SUFU research network. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of botulinum toxin injection in the treatment of de novo OAB symptoms following midurethral sling surgery. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo controlled pilot study of intradetrusor injections of onabotulinumtoxinA for the treatment of refractory overactive bladder persisting following surgical management of benign prostatic hyperplasia. [2018]

8. France pubmed.ncbi.nlm.nih.gov

[Botulinium toxin and idiopathic overactive bladder: Multicentric contempory management in Bourgogne]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Urinary retention in female OAB after intravesical Botox injection: who is really at risk? [2018]

10. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A for the treatment of non-neurogenic overactive bladder: does using onabotulinumtoxinA (Botox(®) ) or abobotulinumtoxinA (Dysport(®) ) make a difference? [2018]