Analgesia for Overactive Bladder

Overseen By Grace Khaner

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Disqualifiers: Pregnancy, UTI, Neurogenic bladder, 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

Compensation: Varies

Number of Visits: 1

Duration: Day of the procedure

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn more about using phenazopyridine (Pyridium) for pain control during bladder onabotulinumtoxinA ("botox") injections for surgical management of overactive bladder (OAB) for patients at Montefiore Medical Center in The Bronx. It will also learn about if using the phenazopyridine pill affects how satisfied patients are with their experience, how much pain patients feel afterwards, and if doctors think using the Pyridium pill affected how they performed the procedure. The main question it aims to answer is: - Is oral phenazopyridine at least as good as intravesical lidocaine is for managing pain with bladder botox injections for OAB in Montefiore patients? Researchers will compare phenazopyridine to intravesical lidocaine, a liquid put into the bladder, to see if phenazopyridine is at least as good at controlling pain with bladder botox injections as intravesical lidocaine is. Participants will be assigned, by chance, to receive either the oral phenazopyridine pill or the intravesical lidocaine as their pain control for the procedure.

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 1% lidocaine with sodium bicarbonate, Phenazopyridine for overactive bladder?

Research suggests that lidocaine, when used in the bladder, can help reduce bladder sensation and overactivity, making it a potential alternative treatment for overactive bladder symptoms. ^{1 2 3 4 5}

How does the drug Phenazopyridine differ from other treatments for overactive bladder?

Phenazopyridine is unique because it is primarily used to relieve urinary tract discomfort rather than directly treating overactive bladder symptoms. Unlike anticholinergic drugs that target bladder muscle contractions, Phenazopyridine works by providing pain relief and reducing irritation in the urinary tract. ^{6 7 8 9 10}

Research Team

Melissa Laudano, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for patients at Montefiore Medical Center with overactive bladder conditions who are undergoing botox injections for treatment. Participants should not have any health issues that would interfere with the study or medication use.

Inclusion Criteria

Provided informed consent

I am a woman aged 18 or older.

I am planning to have Botox injections for overactive bladder at Montefiore.

Exclusion Criteria

I have been diagnosed with a neurogenic bladder.

I have undergone radiation therapy in the pelvic area.

I have significant memory or thinking problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral phenazopyridine or intravesical lidocaine for pain control during bladder Botox injections

Day of the procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including self-reported use of additional analgesia and patient satisfaction

3 days

Treatment Details

Interventions

• 1% lidocaine with sodium bicarbonate
• Phenazopyridine

Trial Overview The study compares oral phenazopyridine (Pyridium) to intravesical lidocaine, which is a liquid administered into the bladder, to see if Pyridium can manage pain as effectively during bladder botox injections.

Participant Groups

Group I: Intravesical lidocaine Active Control 1 Intervention

Patients randomized to the intravesical lidocaine arm will be administered 50 cubic centimeters (cc) of 1% lidocaine with 50cc sodium bicarbonate within the bladder immediately prior to the procedure.

Group II: Oral phenazopyridine Active Control 1 Intervention

Patients randomized to the oral phenzopyridine arm will receive 200 milligrams (mg) phenazopyridine orally prior to the scheduled procedure.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

References

1. Slovakia pubmed.ncbi.nlm.nih.gov

Neuromodulative treatment of overactive bladder--noninvasive tibial nerve stimulation. [2016]

2. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Gabapentin in Comparison to Solifenacin Succinate in Adult Overactive Bladder Treatment. [2018]

3. Poland pubmed.ncbi.nlm.nih.gov

[Capsaicin and lidocaine usage in functional disorders of urinary bladder]. [2017]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and tolerability profiles of anticholinergic agents used for the treatment of overactive bladder. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Gabapentin for overactive bladder and nocturia after anticholinergic failure. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Urinary bladder relaxation through activation of opioid μ-receptors induced by loperamide is increased in diabetic rats. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Injectable, Adhesive, and Self-Healing Composite Hydrogels Loaded With Oxybutynin Hydrochloride for the Treatment of Overactive Bladder in Rats. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Optogenetic silencing of nociceptive primary afferents reduces evoked and ongoing bladder pain. [2019]

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

Pharmacological agents for the treatment of urinary incontinence due to overactive bladder. [2019]

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

Novel pyrazolo[1,5-a]pyridines as orally active EP1 receptor antagonists: Synthesis, structure-activity relationship studies, and biological evaluation. [2018]