Nerve Stimulation Therapy for Bladder Pain Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Walter Reed National Military Medical Center
Disqualifiers: Neurostimulation, Malignancy, Coagulation, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?Many women suffer from bladder pain syndrome (BPS). There are many treatments, but there is no one universally effective option. The goal of this clinical trial is to explore the use of electrical energy directed towards a group of nerves, called the superior hypogastric plexus, for treatment of BPS in women over the age of 18 with a diagnosis of BPS. The main question it aims to answer is: does use of electrical micro-current directed at the superior hypogastric plexus improve pain associated with BPS over the use of placebo?
There is data from many different studies that suggest that this kind of therapy might provide relief of BPS symptoms.
Participants will be asked to participate for a total of six months from the date of their first nerve treatment. At the first appointment, they will be evaluated in the Walter Reed Chronic Pain clinic and asked several questions about the severity and personal management of their symptoms. The procedure will then be performed by inserting two needles into the back (one on either side of the spine) and directing extremely short bursts of electrical micro-current towards the target nerve. The medical term for this is "pulsed radiofrequency ablation." This procedure causes disruption on a microscopic level of nerve fibers that send pain sensations to the bladder and other organs in the pelvis. Some participants will receive treatment, whereas others will receive sham (placebo). Participants will not be informed of their treatment group until the conclusion of the study. Following this initial appointment, participants will be asked about their symptoms at 1-, 3-, and 6-month follow-up appointments. Participants will be asked about pain, mood symptoms, sexual function, and measures of bladder irritation. The procedure will only be performed once.
At the study conclusion, researchers will compare treatment and sham groups to see if pain scores, as well as other secondary outcomes listed above, are different between these groups.
Benefits of this study may include possible relief of BPS symptoms. This may help to advance research about treatments for BPS. This is a novel approach to the treatment of BPS and as such may provide benefits greater than those found in treatment outside of the study.
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 data supports the effectiveness of the treatment Pulsed Radiofrequency Ablation for Bladder Pain Syndrome?
Research on similar treatments, like percutaneous tibial nerve stimulation, shows that nerve stimulation can help manage symptoms of bladder pain syndrome by reducing pain and improving bladder function. Additionally, neuromodulation, which involves stimulating nerves to alter pain signals, is recommended for patients who do not respond to other treatments.
12345Is nerve stimulation therapy using pulsed radiofrequency safe for humans?
Pulsed radiofrequency (PRF) has been safely used to manage various types of pain, including joint and neuropathic pain, by using low energy bursts to modulate nerve activity without causing significant damage.
678910How is pulsed radiofrequency ablation treatment different from other treatments for bladder pain syndrome?
Pulsed radiofrequency ablation (PRF) is unique because it uses low energy, short bursts of radiofrequency to modulate nerve activity, which can help manage pain without destroying tissue. This approach is different from other treatments for bladder pain syndrome, as it focuses on altering nerve signals rather than using medications or invasive procedures.
4671011Eligibility Criteria
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 am 18 years old or older.
+1 more
Exclusion Criteria
I have a neurogenic bladder or a spinal cord injury.
I have an infection where I get my shots.
Current pregnancy
+7 more
Trial Timeline
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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pulsed Radiofrequency Ablation ArmExperimental Treatment1 Intervention
18 total subjects in this arm. Subjects will be laid in the prone position. Local anesthesia will be administered. The appropriate spinal interspace will be identified under fluoroscopic guidance and hollow-tip needles will be inserted through the back into the retroperitoneal space adjacent to the superior hypogastric plexus. A microelectrode will be inserted through the hollow needle. A test pulse will be delivered. When proper positioning has been confirmed, 4mL of 1% lidocaine without epinephrine will be administered to reduce discomfort associated with radiofrequency ablation. Pulsed radiofrequency ablation will be performed at a pulse frequency of 2Hz, pulse width of 20ms, temperature of 42 degrees Celsius, total duration 120 seconds. The microelectrode and hollow-tip needle will then be withdrawn.
Group II: Sham ArmPlacebo Group1 Intervention
18 total subjects in this arm. Subjects will be laid in the prone position. Local anesthesia will be administered. The appropriate spinal interspace will be identified under fluoroscopic guidance and hollow-tip needles will be inserted through the back into the retroperitoneal space adjacent to the superior hypogastric plexus. A microelectrode will be inserted through the hollow needle. A test pulse will be delivered. Sham pulsed radiofrequency ablation will then be performed with the radiofrequency generator disconnected from the microelectrode. The duration of the sham procedure will be 120 seconds. The microelectrode and hollow-tip needle will then be withdrawn.
Pulsed radiofrequency ablation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Pulsed Radiofrequency Ablation for:
- Bladder Pain Syndrome (BPS)
- Chronic Pelvic Pain
🇪🇺 Approved in European Union as Pulsed Radiofrequency Ablation for:
- Bladder Pain Syndrome (BPS)
- Chronic Pelvic Pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Walter Reed National Military Medical CenterBethesda, MD
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Who Is Running the Clinical Trial?
Walter Reed National Military Medical CenterLead Sponsor
References
Percutaneous tibial nerve stimulation for the treatment of interstitial cystitis/bladder pain syndrome: a pilot study. [2021]Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition that requires multimodal management. The American Urologic Association includes sacral neuromodulation in the treatment algorithm for refractory IC/BPS. We sought to determine the rate of overall symptom improvement of IC/BPS symptoms, using validated measures, after treatment with percutaneous tibial nerve stimulation (PTNS), a form of peripheral neuromodulation.
Comparison of the Clinical Efficacy and Adverse Events between Intravesical Injections of Platelet-Rich Plasma and Botulinum Toxin A for the Treatment of Interstitial Cystitis Refractory to Conventional Treatment. [2023]Intravesical injection of Botulinum toxin A (BoNT-A) and platelet-rich plasma (PRP) have been reported to alleviate bladder pain and decrease nocturia in patients with refractory interstitial cystitis/bladder pain syndrome (IC/BPS). Both treatments are novel and there has no comparison between them. This study compared the therapeutic effects and adverse events between IC/BPS patients receiving PRP or BoNT-A injections.
Pulsed electromagnetic field (PEMF) as an adjunct therapy for pain management in interstitial cystitis/bladder pain syndrome. [2022]Patients with interstitial cystitis/bladder pain syndrome (IC/BPS) often experience chronic pelvic and even systemic pain that can be difficult to clinically manage. Pulsed electromagnetic field (PEMF) therapy, a non-invasive strategy that has shown significant efficacy for pain reduction in other chronic pain conditions, may provide benefit for pain management in patients with IC/BPS.
Current role of neuromodulation in bladder pain syndrome/interstitial cystitis. [2022]Neuromodulation is recommended by major international guidelines as a fourth-line treatment in bladder pain syndrome/interstitial cystitis (BPS/IC) patients after failure of behavioural, oral and intravesical pharmacological treatments, including hydrodistension. A non-systematic review of studies identified by electronic search of MEDLINE was performed with no time limitation. A narrative synthesis of the existing evidence regarding the results of sacral, tibial and pudendal nerve stimulation in the management of BPS/IC was developed. Neuromodulation in pelvic chronic pain disorders, including BPS/IC, is a useful tool for refractory patients to conventional treatments. Sacral neuromodulation may be effective in patients with BPS without Hunner's lesions, and the effect seems to be maintained in the mid- and long-term. Posterior tibial nerve stimulation can be offered to patients with BPS/IC in the context of a multidisciplinary approach. When pudendal neuralgia is suspected, selective pudendal nerve stimulation has a high response rate. The aetiology of the pain can influence the outcomes in the mid- and long-term of the different neuromodulation approaches, thus careful diagnosis is recommended.
Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study. [2017]More than 20 million Americans have an overactive bladder, the predominant symptoms being frequency, urgency, urge incontinence and pelvic pain. While the etiology is not completely understood, most investigators believe the causes to be many and the pelvic floor to be intimately related. Whatever the etiology, traditional therapies, including dietary manipulation, bladder drill, medications and physical therapy, are often poorly tolerated and/or ineffective. We report a prospective, multicenter clinical trial that was undertaken to determine the safety and efficacy of percutaneous peripheral afferent nerve stimulation for treatment of refractive overactive bladder and/or pelvic floor dysfunction.
Efficacy and Safety of Pulsed Radiofrequency as a Method of Dorsal Root Ganglia Stimulation in Patients with Neuropathic Pain: A Systematic Review. [2021]Pulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. We conducted a systematic review with the aim to create a synthesis of evidence about the efficacy and safety of PRF applied to the dorsal root ganglion (DRG) for the treatment of neuropathic pain.
Pulsed Radiofrequency in Interventional Pain Management: Cellular and Molecular Mechanisms of Action - An Update and Review. [2021]Pulsed radiofrequency (PRF) treatment uses low energy, short pulsations to modulate tissue characteristics. PRF treatment has been effective as an interventional pain management technique to treat a variety of chronic neuropathic pain (neuralgia) disorders, but a comprehensive review of its biological mechanism has not been updated in a decade.
Long-term Outcomes of Pulsed Radiofrequency for Supraorbital Neuralgia: A Retrospective Multicentric Study. [2022]Pulsed radiofrequency (PRF) is a percutaneous, micro-invasive, and micro-destructive neuromodulation technology. It has been reported to be useful in the treatment of supraorbital neuralgia (SN). However, the long-term effectiveness and safety of this technique in SN has not been reported yet.
A comprehensive review of pulsed radiofrequency in the treatment of pain associated with different spinal conditions. [2022]The objective of this review was to evaluate the efficacy of pulsed radiofrequency (PRF) treatment of pain associated with different spinal conditions. The mechanisms of action and biological effects are shortly discussed to provide the scientific basis for this radiofrequency modality.
The Effectiveness of Pulsed Radiofrequency on Joint Pain: A Narrative Review. [2020]Pulsed radiofrequency (PRF) stimulation has been safely and effectively applied for controlling various types of pain.
Management of neuropathic pain induced by cubital tunnel syndrome using pulsed radiofrequency: Two case reports. [2022]Recently, pulsed radiofrequency (PRF) has been applied to alleviate neuropathic pain caused by various peripheral nerve pathologies. This report describes and discusses the cases of 2 patients with cubital tunnel syndrome who responded well to PRF for the management of neuropathic pain.