What side effects are associated with this type of intervention?

Common treatments for urological diseases, such as acupuncture and auricular acupressure, generally have a low incidence of major adverse events. Minor adverse events may include mild pain, bruising, or discomfort at the treatment site. Studies have shown that these treatments are generally safe, with no major adverse events reported. However, the evidence regarding their efficacy is often of low certainty, and further research is needed to confirm their benefits and long-term safety.

What prior FDA approvals exist?

The FDA has approved several treatments for urological diseases that modulate pain through neural pathways. For instance, neuromodulation therapies like sacral nerve stimulation (SNS) have been approved for conditions such as overactive bladder and interstitial cystitis/bladder pain syndrome (IC/BPS). Additionally, medications like duloxetine, an SNRI, have been used off-label for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) due to their pain-modulating effects. While auricular acupressure is still under study, these existing treatments highlight the FDA's recognition of neural pathway modulation as a viable approach for managing urological pain.

What other types of research exist?

Promising novel alternatives to Auricular Acupressure for urological diseases include Transcutaneous Electrical Nerve Stimulation (TENS), which has shown efficacy in various pain syndromes, and acupuncture, which has demonstrated pain relief through modulation of neural pathways. Both methods are non-invasive and have been supported by clinical evidence for their effectiveness in pain management.

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Auricular Acupressure for Interstitial Cystitis (IC/BPS Trial)

N/A

Waitlist Available

Led By Stephen Walker, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of documented interstitial cystitis/bladder pain syndrome (IC/BPS)

Age >= 18 years

Must not have

Patients with a history of skin disease (e.g. psoriasis) involving the ear, adhesive allergy, recent scar tissue on ear, or current abrasions or cuts on the ear

Physical impairment preventing them from applying daily pressure/stimulation to ear seeds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 1, day 2, day 3, day 4, day 5

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether pressing on small pads placed on the ears can help reduce pain for people with chronic bladder pain. Participants will press on these pads regularly and report their pain levels. The goal is to see if this method can lower their pain and reduce their need for pain medication.

Who is the study for?

This trial is for adults over 18 with confirmed interstitial cystitis/bladder pain syndrome who can understand English. It's not suitable for those with ear skin diseases, adhesive allergies, recent ear scars or cuts, cognitive impairments, physical inability to apply pressure to the ear, pacemaker users, certain hearing aid users, or anyone with acute illnesses or psychiatric conditions affecting study participation.

What is being tested?

The study tests auricular acupressure's effectiveness in reducing pain and lessening the need for pain medication in patients suffering from interstitial cystitis/bladder pain syndrome. Participants will receive auricular acupressure therapy and their responses will be monitored.

What are the potential side effects?

While specific side effects are not detailed for auricular acupressure in this summary, potential general concerns may include discomfort at the application site on the ear or an allergic reaction if one has a sensitivity to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a documented history of interstitial cystitis or bladder pain.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of skin issues or recent injuries on my ear.

Select...

I cannot apply pressure to ear seeds due to a physical impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 1, day 2, day 3, day 4, day 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 1, day 2, day 3, day 4, day 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 1, day 2, day 3, day 4, day 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain, Enjoyment, and General Activity (PEG) Assessment Scores

Pain scores using Numeric Rating Scale (NRS)

Secondary study objectives

Auricular Acupressure Acceptability - Feedback

Auricular Acupressure Acceptability - Likert scale scores

Auricular Acupressure Acceptability - auricular acupressure

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Auricular Acupressure (AA) GroupExperimental Treatment1 Intervention

Participants will receive the AA intervention over a 5 day period in addition to their Standard of Care treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), and complete daily study questionnaires

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for urological diseases include pharmacological therapies, behavioral interventions, and non-pharmacological methods like acupuncture and auricular acupressure. Pharmacological treatments often work by modulating neurotransmitter activity or hormonal pathways to alleviate symptoms. Behavioral interventions aim to retrain bladder function and improve lifestyle factors. Non-pharmacological methods like auricular acupressure and acupuncture modulate pain and symptoms through neural pathways, potentially involving the release of endorphins and other neurotransmitters. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, considering both efficacy and potential side effects.

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