The Pelvic Floor Disorders Network conducts clinical research studies to learn more about how to help women with pelvic floor problems. Women who are considering whether to participate in these clinical research studies often have questions about clinical research and clinical trials. The information on this page and the links at the bottom of the page provide additional information to help answer these questions.
What are clinical trials?
Clinical research is research that either directly involves a particular person or group of people or uses materials from humans, such as their behavior or samples of their tissue, to answer important clinical or health-related questions. A clinical trial is a research study in which humans volunteer to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat human diseases. Different types of clinical trials within the Pelvic Floor Disorders Network include:
Why are clinical trials done?
Treatment trials test new treatments (like a new drug to reduce incontinence, new surgical approaches, or improved behavioral therapy procedures).
- Prevention trials test new approaches, such as medicines, exercise regimens, or surgical procedures that doctors believe may lower the risk of getting a specific pelvic floor disorder.
- Screening trials test the best way to detect specific pelvic floor disorders or to identify individuals with characteristics that make the disorder more easily treated with specific measures.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied.
- Quality of Life trials (also called Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic pelvic floor problem.
Clinical trials help doctors learn what are the best tests and treatments for a given condition and to help determine whether treatments are safe and effective for people to use. Often clinical trials compare existing treatment options to determine which is better. Without these trials, doctors may not know the best way to diagnose or treat a health problem. When a pelvic floor problem has more than one treatment option, doctors may not know which treatment works the best, lasts the longest, or has the least side effects. For example, women who have bladder control problems may be offered medication, physical therapy, or even surgery. A clinical trial could compare medication to physical therapy, and the results of the trial helps doctors and patients in the future to make the best choice about which treatment to pick.
Before starting a clinical trial, researchers get approval from committees (such as Institutional Review Boards, or IRBs) at their medical centers. If you are thinking about being in a clinical trial, the researchers will give you more information in writing. For most types of research, you need to give your permission in writing before you can be part of a clinical trial. It is up to you to decide whether to join a clinical trial. The researchers will answer any questions that you have about being in a clinical trial before you sign up.
Where can people find out more about clinical trials?
You can find information about clinical trials now being conducted by searching ClinicalTrials.gov which is an interactive, online database managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research in human volunteers. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, eligibility requirements, locations, and phone numbers to call for more information. Other sources of information are linked below:
Food and Drug Administration (FDA)
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)