38 Participants Needed

Nerve Stimulation Therapy for Bladder Pain Syndrome

SW
EM
Overseen ByEli Medvescek, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Walter Reed National Military Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat bladder pain syndrome (BPS) by using electrical energy to target specific nerves. Researchers aim to determine if this nerve stimulation, known as pulsed radiofrequency ablation, reduces pain more effectively than a placebo. Women diagnosed with BPS who feel it impacts their daily life might be suitable candidates. Participants will receive either the actual treatment or a placebo and will be monitored over six months to track changes in pain and other symptoms. The goal is to discover a more effective way to relieve BPS symptoms. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for BPS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an implantable neurostimulation device, you cannot participate in the trial.

What prior data suggests that this nerve stimulation therapy is safe for treating bladder pain syndrome?

Research has shown that pulsed radiofrequency ablation, the treatment under study, has promising safety results from past studies. This therapy has provided long-term pain relief for conditions similar to bladder pain syndrome. Reports and studies suggest that patients tolerated the procedure well and experienced less pain without major side effects. For example, one study found that pain relief lasted over two years without serious problems. While every medical procedure carries some risk, current data suggest that this treatment is generally well-tolerated. These findings are important to consider for those thinking about joining the trial.12345

Why are researchers excited about this trial?

Researchers are excited about pulsed radiofrequency ablation for bladder pain syndrome because it uses a unique approach to manage pain. Unlike traditional treatments like oral medications or physical therapies, this method targets the superior hypogastric plexus, a nerve center involved in pain transmission. By using precise, pulsed energy, it aims to disrupt pain signals without causing significant damage to surrounding tissues. This technique could offer relief for patients who haven't had success with other treatments, providing a new, minimally invasive option for managing chronic bladder pain.

What evidence suggests that pulsed radiofrequency ablation is effective for bladder pain syndrome?

Research shows that pulsed radiofrequency ablation, which participants in this trial may receive, can provide long-lasting relief from bladder pain syndrome (BPS). Studies have found that this treatment can reduce pain and improve symptoms for over two years in some cases. In one study, patients experienced significant pain relief and fewer urinary problems after the procedure. Another study suggested that pulsed radiofrequency might help patients who don't get relief from standard treatments. This therapy interrupts nerve signals that send pain messages to the bladder, potentially easing BPS symptoms.12367

Who Is on the Research Team?

EM

Eli Medvescek, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

This trial is for women over 18 with bladder pain syndrome (BPS), who are eligible for DEERS health care benefits and have a specific score on a BPS diagnostic test. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

DEERS-eligible health care beneficiaries
I am female.
I have been diagnosed with Bladder Pain Syndrome.

Exclusion Criteria

I have a neurogenic bladder or a spinal cord injury.
I have an infection where I get my shots.
Current pregnancy
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulsed radiofrequency ablation or sham procedure targeting the superior hypogastric plexus

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up appointments at 1, 3, and 6 months

6 months
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Pulsed radiofrequency ablation
  • Sham ablation
Trial Overview The study tests pulsed radiofrequency ablation—a procedure using electrical micro-currents aimed at nerves to relieve BPS symptoms—against sham ablation, which is like a placebo. Participants will be compared after one treatment over six months.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pulsed Radiofrequency Ablation ArmExperimental Treatment1 Intervention
Group II: Sham ArmPlacebo Group1 Intervention

Pulsed radiofrequency ablation is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Pulsed Radiofrequency Ablation for:
🇪🇺
Approved in European Union as Pulsed Radiofrequency Ablation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials
149
Recruited
33,800+

Published Research Related to This Trial

Pulsed radiofrequency (PRF) applied to the dorsal root ganglion (DRG) shows potential for treating neuropathic pain, but the evidence is primarily based on small studies with low quality, as only 5 out of 28 studies were randomized controlled trials (RCTs).
With a total of 991 participants across all studies, the overall quality of evidence is very low, indicating that the current findings on PRF's efficacy and safety are preliminary and need to be validated through larger, high-quality RCTs.
Efficacy and Safety of Pulsed Radiofrequency as a Method of Dorsal Root Ganglia Stimulation in Patients with Neuropathic Pain: A Systematic Review.Vuka, I., Marciuš, T., Došenović, S., et al.[2021]
Pulsed radiofrequency (PRF) treatment effectively modulates various biological pathways involved in chronic neuropathic pain, impacting nociceptive signaling, immune activity, and synaptic function, as identified in a review of 20 publications.
PRF treatment influences key components such as ion channels, neurotransmitters, and inflammatory cytokines, suggesting a complex mechanism of action that may help in pain management, although definitive causal relationships to clinical outcomes remain unclear.
Pulsed Radiofrequency in Interventional Pain Management: Cellular and Molecular Mechanisms of Action - An Update and Review.Sam, J., Catapano, M., Sahni, S., et al.[2021]
In a pilot study of 21 subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), 70% experienced some degree of symptom improvement after treatment with percutaneous tibial nerve stimulation (PTNS), although only 30% met the criteria for 'moderately' or 'markedly improved' on the Global Response Assessment after 12 weeks.
The study reported no adverse events associated with PTNS, suggesting it is a safe treatment option for managing IC/BPS symptoms, despite the challenges in recruitment and follow-up that limited the statistical significance of the findings.
Percutaneous tibial nerve stimulation for the treatment of interstitial cystitis/bladder pain syndrome: a pilot study.Sudol, NT., Guaderrama, N., Adams-Piper, E., et al.[2021]

Citations

Pulsed radiofrequency treatment of the superior ...This case report showed that long-term pain relief and regression of lower urinary tract symptoms were achieved for up to 2 years and 6 months ...
Evaluation of Pulsed Radiofrequency Ablation of the ...chronic pelvic pain, bladder pain syndrome, interstitial cystitis, superior hypogastric plexus, pulsed radiofrequency ablation. 9.2 Background and ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/27930554/
Pulsed radiofrequency treatment of the superior ...Outcomes: This treatment relieved the pain and symptoms for 2 years and 6 months. Lessons: PRF treatment of the superior hypogastric plexus results in long- ...
Nerve Stimulation Therapy for Bladder Pain SyndromePulsed radiofrequency (PRF) treatment effectively alleviated neuropathic pain in two patients with cubital tunnel syndrome, with one patient experiencing ...
Pulsed Radiofrequency May Provide Relief When Other IC ...The authors say that PRF treatment could provide long-term improvements in pain and symptoms for other IC patients who aren't achieving relief with standard ...
Diagnosis and Treatment of Interstitial Cystitis/Bladder Pain ...The purpose of this clinical guideline is to provide a clinical framework for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome (IC/ ...
(PDF) Pulsed radiofrequency treatment of the superior ...Outcomes: This treatment relieved the pain and symptoms for 2 years and 6 months. associated with interstitial cystitis. Abbreviations: PRF = ...
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