What is a clinical research study?
What is the EPPIC clinical study and its purpose?
Why study non-drug treatments for pelvic pain?
What are the alternatives for the treatment of pelvic pain?
Who is funding this study?
Is the EPPIC study being conducted anywhere else?
Why do people volunteer for research?
What are the potential benefits to participating in the EPPIC study?
What are the potential discomforts or risks of being a research subject?
What are the possible disadvantages of taking part?
Who may be eligible to participate in the EPPIC study?
If I choose to participate in the EPPIC study, can I continue to take my usual pelvic pain medication during the study period?
Will I have to pay anything?
If I volunteer, is there any way I can change my mind later?
Will my participation be kept confidential?
How can I find out about the results of this research?
How do I become a participant in the EPPIC study and whom can I contact for further information?
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.
What is the EPPIC clinical study and its purpose?
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.
Why study non-drug treatments for pelvic pain?
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.
What are the alternatives for the treatment of pelvic pain?
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.
Who is funding this study?
This study is funded by the National Institutes of Health.
Is the EPPIC trial being conducted anywhere else?
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.
Why do people volunteer for research?
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:
- 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.
- Participants in clinical trials feel empowered over their health care.
- Participants help increase knowledge about treating chronic pelvic pain that can only be discovered in studies such as this.
What are the potential benefits of participating in the EPPIC study?
Patients receive excellent state-of-the-art care from an experienced caring group of doctors. Individuals with moderate to severe pelvic pain who have undergone treatments featured in the study typically report a significant reduction in the severity and impact of pain symptoms. EPPIC participants also may receive:
- Non-invasive, diagnostic assessment – free of charge
- Home-based drug-free treatment with limited clinic visits – free of charge
- Payment for time and contribution related to the study
Individuals with moderate to severe pelvic pain who have undergone treatments featured in the study typically report a significant reduction in the severity and impact of pain symptoms.
What are the potential discomforts or risks of being a research subject?
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.
What are the possible disadvantages of taking part?
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.
Who may be eligible to participate in the EPPIC study?
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:
- Suffer from moderate-to-severe pelvic pain symptoms (pelvic pain associated with urinary urgency and/or frequency)
- Experience symptoms for at least the past three months
- Are between the ages of 18 and 70
- Are male or female
If I choose to participate in the EPPIC study, can I continue to take my usual pelvic pain medication during the study period?
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.
Will I have to pay anything?
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.
If I volunteer, is there any way I can change my mind later?
Yes. Although it is preferred that volunteers are committed to completing the study, volunteers are free to withdraw at any time.
Will my participation be kept confidential?
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.
How can I find out about the results of this research?
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.
How do I become a participant in the EPPIC study and whom can I contact for further information?
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.