Nerve Stimulation Therapy for Bladder Pain Syndrome
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo pulsed radiofrequency ablation or sham procedure targeting the superior hypogastric plexus
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up appointments at 1, 3, and 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Pulsed radiofrequency ablation
- Sham ablation
Pulsed radiofrequency ablation is already approved in United States, European Union for the following indications:
- Bladder Pain Syndrome (BPS)
- Chronic Pelvic Pain
- Bladder Pain Syndrome (BPS)
- Chronic Pelvic Pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
Walter Reed National Military Medical Center
Lead Sponsor