What is a clinical research study?

A clinical research study, or trial, is a systematic way of finding answers to difficult scientific or health questions. For example, doctors may do a research study to find out if a new medicine helps improve eyesight. Clinical trials follow pre-defined protocols, which is a detailed plan for conducting the study, and are strictly regulated by the federal government.

The EPPIC study is a federally funded clinical study that tests the effectiveness of two types of drug-free treatments for adults with moderate to severe pelvic pain. Additional study goals aim to understand the reasons why treatments relieve pelvic pain symptoms, identify individuals for whom treatment is most effective, and track it. The EPPIC study is a federally funded clinical study that tests the effectiveness of two types of drug-free treatments for adults with moderate to severe pelvic pain and bladder problems (urinary frequency, urinary urgency, or both). Additional study goals aim to understand the reasons why treatments relieve pelvic pain symptoms, identify individuals for whom treatment is most effective, and track the durability of treatment gains over six months. All treatment featured in this study has been proven effective in previous clinical trials. Because it is not clear which of the treatments would be better for you, patients are assigned to one of the two treatments by a random process.

Unfortunately, there is no medical cure for pelvic pain. The goal of state-of-the-art treatment is to help patients learn ways to control flare-ups and live more comfortably and productively.

Currently, there is no cure for pelvic pain. Medications, medical procedures, and dietary agents provide unsatisfactory relief for most patients and are often associated with unpleasant side effects. The non-drug treatments featured in the EPPIC trial are recognized as some of the most effective pelvic pain treatments available.  Because they are drug-free, they are not associated with adverse side effects. 

This study is funded by the National Institutes of Health.

There are two other universities across the United States that are participating in this study in conjunction with the University at Buffalo. These sites include:

The University at Buffalo is the only institution where treatment is provided.

Evidence shows that treatment centers such as the University at Buffalo Behavioral Medicine Division that are active in research and deliver clinical research trials achieve better outcomes. Patients who participate in research enable clinical staff to be better informed about their condition, medical care, and treatment. Some of the common reasons for participating in research are:

  1. Participants in a clinical trial gain access to new, state-of-the-art treatments that are free and administered by experts before they are widely available.
  2. Participants in clinical trials feel empowered over their health care.
  3. Participants help increase knowledge about treating chronic pelvic pain that can only be discovered in studies such as this.

Patients receive excellent state-of-the-art care from an experienced caring group of doctors. EPPIC participants also may receive:

  1. Non-invasive, diagnostic assessment – free of charge
  2. Home-based drug-free treatment with limited clinic visits – free of charge

It is impossible to eliminate every risk in testing a new treatment. However, unnecessary risks are avoided, and many safeguards are built into the research to minimize the harm that might occur if patients have an unfavorable response to the treatment. A careful review process to protect the health of human subjects is conducted before a study is approved.

Because this trial features non-drug treatment, potential side effects are few, generally minor, and time-limited. The biggest inconvenience is the time required to complete the assessment and clinic visits. 

Specific criteria have been established to determine who is eligible to participate in this research study. These criteria are based on such factors as age, disease/condition, previous treatment history, and other medical conditions. You may be eligible to participate in this clinical study if you: 

  1. Suffer from moderate-to-severe pelvic pain symptoms (pelvic pain associated with urinary urgency and/or frequency)
  2. Experience symptoms for at least the past three months
  3. Are between the ages of 18 and 70
  4. Are male or female

Yes. Patients are not required to stop any medical or dietary treatment for pelvic pain while they are being treated. We only ask patients to notify us of what treatments they are taking, the medication dosages, and any changes to these treatments. 

No. There is no charge for pre-treatment assessment and those who qualify and choose to participate will receive treatment and follow-up assessment free of charge. All eligible subjects will be paid for their time and travel for completing post-treatment follow-up visits. 

Yes. Although it is preferred that volunteers are committed to completing the study, volunteers are free to withdraw at any time.

Yes, your anonymity will be protected within the limits of the law. No medical information will be released to outside individuals without your written permission. No names are given when reports on trials are made to the scientific community.

The results of the study will not be published until all of the participants have finished. A summary of the main findings is usually provided to interested participants.

If you think you might be eligible for this study, please call us at 716-898-6254 to see if you qualify for an evaluation. 

Yes, you will be paid/compensated for your time and contribution related to the study.