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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

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 data supports the effectiveness of the drug lidocaine for treating overactive bladder?

Research shows that lidocaine, when used directly in the bladder, can help improve bladder function in various conditions, including overactive bladder in patients with brain or spinal issues, and in animal models. Additionally, lidocaine has been effective in relieving symptoms of interstitial cystitis, a condition with similar bladder symptoms. ^{1 2 3 4 5}

Is lidocaine safe for use in humans?

Lidocaine, used as a local anesthetic, has been shown to be safe in humans when used in the bladder, with studies reporting no adverse reactions and plasma concentrations below toxic levels. ^{1 3 5 6 7}

How is the drug Lidocaine unique for treating overactive bladder?

Lidocaine is unique for treating overactive bladder because it is a local anesthetic that numbs the bladder lining, potentially reducing the urge to urinate frequently. This approach is different from other treatments that typically target bladder muscle contractions or nerve signals. ^{8 9 10 11 12}

Research Team

Sean Francis, MD

Principal Investigator

University of Louisville

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Diagnostic value of intravesical lidocaine for overactive bladder. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

Effects of 1% Lidocaine Instillation on Overactive Bladder Induced by Bladder Outlet Obstruction in Rats. [2021]

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

The effects of intravesical lidocaine on bladder dynamics of children with myelomeningocele. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Intravesical lidocaine in severe interstitial cystitis. Case report. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Intravesical sustained release system of lidocaine and oxybutynin results from in vitro and animal study. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of available therapies in the management of idiopathic overactive bladder: A systematic review of the literature]. [2018]

8. Iran pubmed.ncbi.nlm.nih.gov

A spectroscopic assessment of interaction between 4% articaine hydrochloride with adrenaline and various endodontic irrigants. [2022]

9. Iran pubmed.ncbi.nlm.nih.gov

Interaction between lidocaine hydrochloride (with and without adrenaline) and various irrigants: A nuclear magnetic resonance analysis. [2022]

10. Turkey pubmed.ncbi.nlm.nih.gov

Influence of Lignocaine Hydrochloride with Adrenaline on Free Active Chlorine Content of Sodium Hypochlorite Solution Admixed in Various Proportions. [2022]

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

The effect of sodium hypochlorite application on the success of calcium hydroxide pulpotomy in primary teeth. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Inadvertent injection of sodium hypochlorite into the maxillary sinus. [2019]