Lidocaine for Overactive Bladder

Overseen By Laurel Carbone, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Louisville

Disqualifiers: Untreated UTI, Pregnancy, 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: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of different amounts of the bladder-numbing medication, lidocaine, in relieving pain during bladder Botox injections. It compares two groups: one receives a higher volume of lidocaine, and the other a lower volume. The goal is to determine which amount is more effective and safe for women with overactive bladder conditions, such as frequent urges or incontinence, that haven't improved with other treatments. Women who have struggled with these bladder issues and have not found relief from other treatments may be suitable candidates. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

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.

What is the safety track record for lidocaine?

Research has shown that intravesical lidocaine, which involves placing lidocaine directly into the bladder, is generally safe. In past studies, patients with bladder conditions used lidocaine and found it well-tolerated. Some reported minor side effects, such as temporary discomfort during the procedure, but these are uncommon. The FDA's approval of lidocaine for other uses adds confidence in its safety. This study tests different amounts of lidocaine to determine the most effective dose, and both amounts have a strong safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using lidocaine for overactive bladder because it offers a unique approach compared to existing treatments like anticholinergics and beta-3 agonists. Unlike these medications, which often have systemic side effects, lidocaine works locally by numbing the bladder, potentially reducing irritation and urgency without affecting the rest of the body. This trial explores two different volumes of lidocaine administered directly into the bladder, which could provide quick relief by directly targeting the bladder lining. This direct approach might offer benefits like faster symptom relief and fewer side effects, making it a promising option for those who struggle with current treatments.

What evidence suggests that this treatment might be an effective treatment for overactive bladder?

This trial will compare two different volumes of intravesical lidocaine for managing pain associated with overactive bladder treatments. Research has shown that administering lidocaine directly into the bladder can reduce pain from these treatments. Studies have found that lidocaine significantly lowers pain levels, especially when used before Botox injections in the bladder. One study discovered that a special form of lidocaine worked better than a placebo in reducing pain. Additionally, lidocaine has increased bladder capacity, particularly in patients with certain neurological conditions. This evidence supports lidocaine's effectiveness in managing bladder pain and discomfort. ^{1 5 6 7 8}

Who Is on the Research Team?

Sean Francis, MD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for individuals with various bladder conditions like overactive bladder and neurogenic bladder. Participants should be scheduled for office Botox injections to manage their condition but cannot join if they have specific health issues that the study doesn't list.

Inclusion Criteria

Able to provide informed consent

I have severe urinary issues not improved by standard treatments.

Exclusion Criteria

Inability to provide informed consent

Pregnancy, breast-feeding, intending to become pregnant within 6 months of treatment

I do not have a current urinary tract infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure

Participants receive intravesical lidocaine instillation 20-30 minutes prior to bladder Botox injections

1 day

1 visit (in-person)

Treatment

Participants undergo office intradetrusor Botox injections with either 200 ml or 30 ml of 2% lidocaine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of pain relief and satisfaction

1 year

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine

Trial Overview The study is testing two different volumes of a numbing medication called lidocaine given during Botox injections in the bladder. It's a controlled test where patients are randomly assigned to receive either 200 ml or 30 ml of lidocaine, without knowing which one they get.

How Is the Trial Designed?

Group I: Higher volume intravesical lidocaine Active Control 1 Intervention

200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox.

Group II: Lower volume intravesical lidocaine Active Control 1 Intervention

30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox.

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

Approved in United States as Lidocaine for:

• Local anesthesia for minor surgical procedures
• Surface anesthesia for minor procedures
• Spinal anesthesia
• Epidural anesthesia

Approved in European Union as Lidocaine for:

• Local anesthesia
• Regional anesthesia
• Surface anesthesia

Approved in Canada as Lidocaine for:

• Local anesthesia
• Regional anesthesia

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

In a study of 102 patients with interstitial cystitis/painful bladder syndrome, treatment with intravesical alkalinized lidocaine (PSD597) resulted in significantly improved bladder symptoms compared to placebo, with 30% of patients reporting moderate to marked improvement three days after treatment.

PSD597 was found to be safe, with peak serum lidocaine levels remaining well below toxic levels, indicating it may avoid the systemic side effects associated with oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. Nickel, JC., Moldwin, R., Lee, S., et al.[2022]

A patient with severe interstitial cystitis experienced significant pain relief and anti-inflammatory effects from repeated vesical instillations of lidocaine, demonstrating its potential as an effective treatment for this condition.

The treatment was safe, as plasma lidocaine levels remained below toxic thresholds and no adverse reactions were reported, indicating a favorable safety profile for lidocaine instillation in managing interstitial cystitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical lidocaine in severe interstitial cystitis. Case report. Asklin, B., Cassuto, J.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00427648

Local Anesthetic Treatments for Overactive Bladder The purpose of this study is to determine whether alkalized lidocaine instilled into the bladder is effective in the treatment of overactive bladder (OAB).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11913603/

Alkalinised lidocaine as an anaesthetic before ... Intravesical instillation of alkalinised lidocaine before BTX‐A injections significantly reduced VAS pain scores compared to placebo.

3. spandidos-publications.com spandidos-publications.com/10.3892/wasj.2022.163

Intravesical indwelling lidocaine‑releasing devices for IC/ ... Lidocaine is effective not only in reducing bladder pain, but also in relieving dyspareunia. Welk and Teichman (34) treated 57 patients with IC/ ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10893580/

Diagnostic value of intravesical lidocaine for overactive ... Results: The percentage increase in bladder capacity for patients with spinal lesions was 136%, compared to 56%, 29% and 41% for patients with brain lesions, ...

5. link.springer.com link.springer.com/article/10.1007/s11884-006-0006-4

Intravesical therapy for overactive bladder Intravesical instillation of anticholinergics such as oxybutynin and atropine can achieve cholinergic blockade without producing systemic side effects.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7028015/

Evaluating the safety and potential activity of URO‐902 (hMaxi ... Here we provide data from two phase 1 trials demonstrating safety and potential efficacy of URO‐902, comprising a gene therapy plasmid vector expressing the ...

7. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16647

Alkalinised lidocaine as an anaesthetic before ... The primary outcome measure was procedural pain rated on a 100-mm visual analogue scale (VAS). Secondary outcomes included adverse effects such ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168365910008266

An intravesical device for the sustained delivery of ... An intravesical lidocaine therapy of three instillations per week for two weeks demonstrated immediate and sustained relief of pain, urgency and frequency of IC ...