Analgesia for Overactive Bladder

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the pill phenazopyridine is as effective as the liquid medicine lidocaine in reducing pain during bladder Botox injections for individuals with overactive bladders. It also evaluates participant satisfaction and whether doctors find the pill impacts their work. Participants will either take the phenazopyridine pill or receive lidocaine (a local anesthetic) in their bladder to compare pain levels. Women planning to undergo bladder Botox treatment at Montefiore Medical Center, who do not have conditions like a current UTI or neurogenic bladder, may be suitable for this trial. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment benefits 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 these treatments?

Previous studies have shown that phenazopyridine, a common medicine for relieving bladder discomfort, is generally safe. The FDA has approved it to help with symptoms like pain and burning during urination. Some people may notice their urine turns reddish-orange, but this is harmless and not a cause for concern.

Research indicates that intravesical lidocaine, a liquid pain reliever applied directly into the bladder, is also well-tolerated. It effectively reduces bladder pain and is considered safe with a good safety margin.

Both treatments are commonly used and known to be safe. Participants in this trial can feel reassured about the safety of these treatments based on past studies and experiences. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for overactive bladder, which typically involve anticholinergic medications or beta-3 adrenergic agonists, the treatments in question use different approaches. Oral phenazopyridine provides relief by acting as a local anesthetic on the urinary tract, which helps to alleviate discomfort and pain associated with the condition. Meanwhile, intravesical lidocaine offers a novel delivery method by being administered directly into the bladder, potentially providing immediate pain relief during procedures. Researchers are excited about these treatments because they offer alternative pain management strategies that could work faster and more effectively than traditional options.

What evidence suggests that phenazopyridine could be an effective treatment for pain control during bladder botox injections for overactive bladder?

Research has shown that applying lidocaine directly into the bladder reduces pain and improves bladder function without affecting the bladder muscles. In this trial, participants will receive either intravesical lidocaine or oral phenazopyridine at random. Oral phenazopyridine often eases pain and discomfort from urinary issues. A study comparing these treatments found that participants were slightly more satisfied with lidocaine, but the difference was not significant. This suggests both treatments manage pain similarly well during bladder procedures. ^{1 2 4 6 7}

Who Is on the Research Team?

Melissa Laudano, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4708535/

Review of intravesical therapies for bladder pain syndrome ... Outcome measures were not well defined, with 92% achieving initial remission for an average of 8 months. Nine patients (36%) had one or more relapses and ...

2. auajournals.org auajournals.org/doi/pdf/10.1097/JU.0000000000002082.12

MP52-12 SODIUM BICARBONATE TO ... CONCLUSIONS: In our cohort, those who received the sodium bicarbonate experienced less pain at first injection compared to those subject to ...

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

Alkalinised lidocaine as an anaesthetic before ... Alkalinising lidocaine with sodium bicarbonate reduces its ionisation, enhancing drug diffusion and intravesical uptake.

4. 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31630385/

Effects of 1% Lidocaine Instillation on Overactive Bladder ... Intravesical instillation of 1% lidocaine improves cystometric parameters without deterioration of contractility by blocking excessive C-fiber activity.

6. 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).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429515000606

Lidocaine in the Diagnosis and Treatment of Interstitial ... Lidocaine is a familiar and readily available LA with a reassuring safety margin when used intravesically. However, there remain many unanswered questions ...