Do you experience Stress Urinary Incontinence?

Due to Chronic Cough?

If you leak urine when you cough you may be eligible for a clinical research study.

The MK‑7264‑042 study is enrolling women who leak urine when they cough. This condition is known as chronic cough induced stress urinary incontinence, or cSUI. The MK‑7264‑042 clinical research study is evaluating an investigational drug to see if it may be a safe and effective treatment for cSUI.

Answer a few questions to see if you may qualify for the MK‑7264‑042 study.

Answer Questions

What is cSUI?

Stress urinary incontinence (SUI) means you leak urine unintentionally as a result of pressure, or stress, on your bladder. This stress happens during physical movements or activities, such as coughing, sneezing, running, laughing, or lifting. If you have a persistent cough and leak urine when you cough, you may have cSUI. However, you may not leak every time you cough to have cSUI.

What factors may contribute to cSUI?

The following factors may put you at increased risk:

  • Type of childbirth delivery
  • Body weight
  • Pelvic surgery
  • Factors that may contribute to persistent cough, such as smoking or allergies

How is cSUI diagnosed?

Your doctor or a specialist may ask you questions, such as how bad your cough is, how often you cough and how often you leak urine when you cough. A pelvic examination may help determine if there could be any underlying conditions causing the leaking. Other tests or activities that could be important in diagnosing cSUI include:

  • Cough stress test. You may be asked to cough while you have a comfortably full bladder with the doctor or a nurse practitioner observing to see if any urine leaks out.
  • Diary entries. You may be asked to keep track of such things as your coughing, urine leakage, how much you drink, and how often you urinate.

How is cSUI treated?

Therapies and treatments are available to help address urinary leaking. Your doctor may recommend behavioral changes, such as adjusting how much you drink and when you drink or quitting smoking. Other potential therapies include the use of external devices designed to control leaking or surgical options.

doctor with patient

Who can participate?

About 380 women are expected to participate. You may qualify to participate if you are a woman and:

  • Are at least 18 years of age
  • Have been diagnosed with a refractory or unexplained chronic cough
  • Have been coughing for more than year
  • Leak urine when you cough

There may be reasons why you cannot be in this study. The study doctor or staff will discuss this with you.

What should I expect?

Before joining the MK‑7264‑042 study, you will be screened to find out if you are eligible. If you are eligible and choose to enroll, your participation will last approximately 22 weeks. It will include 6 scheduled visits to the study clinic and 2 phone calls with the study doctor or staff.

What are my responsibilities in the study?

Clinical studies rely on the cooperation of volunteer participants. While you are taking part in this study, you will need to:

  • Follow instructions from the study doctor and staff
  • Ask questions if you have concerns or need clarification
  • Take your study drug
  • Attend all study visits
  • Complete your study diary entries
  • Tell the study doctor or staff about any changes to your health

Where do I begin?

The first step involves answering a few questions in an online prescreening questionnaire to see if you are a potential candidate for the study. Depending on your answers, you may be referred to a study clinic for screening.

Answer Questions
A Clinical trial is a research study that tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational medication is safe and effective. Studies may help doctors find new ways to help prevent, detect, or treat health problems. Clinical trials may also be referred to as research studies.
Clinical studies follow a specific set of standards and are closely regulated to help protect study participants. An independent Ethics Committee or Institutional Review Board reviews and monitors each study closely to safeguard the rights and welfare of participants. Nevertheless, all clinical studies and investigational products have risks, including the potential to make participants sick or uncomfortable. Although safety precautions are put in place to protect people who participate in clinical studies, your condition or health could remain the same, improve, or get worse. Any known risks and side effects will be discussed during the informed consent process, but there may be unknown risks.
The investigational drug is called gefapixant and is also known as MK-7264. This drug is considered investigational because it is not currently approved for uses other than research.
If you qualify and choose to participate, you will be put into a group by chance, like flipping a coin, to determine what type of study drug you will get:

  • Gefapixant - 1 tablet two times a day
  • Placebo - 1 tablet two times a day

You will have a 50/50 chance of getting either gefapixant or placebo.
The placebo looks like the investigational drug but contains no active ingredients. Placebos are often used in clinical research studies to help evaluate the investigational drug by comparing effects seen in study participants who take the investigational drug to effects seen in those who take placebo.

Although MK-7264-042 study participants who take the placebo will not receive any active drug, they will receive the same care from the study doctor and staff as participants taking the investigational drug. Study activities, including diary entries, study visits, and phone calls will help the study doctor monitor your health and assess your condition (leaking urine when you cough) throughout the study.
You can stop taking part in this study at any time. If you choose not to take part or you agree to take part but then withdraw, medical care you receive outside the study will not be affected. The study doctor will discuss other treatment options with you.
You may need to stop taking certain medications during the study. The study doctor or staff will discuss this with you in detail.
You can visit any doctor to meet your health needs during a study. You should tell other medical professionals you see that you are participating in a clinical study and always communicate openly with the study doctor regarding other care you receive.
At study visits, you will talk with the study doctor or staff about how you are feeling and about other medications you may be taking. You will review your study diary entries with the study doctor or staff and complete questionnaires about your health and your quality of life. At some visits, medical procedures, such as measurement of your vital signs, blood and urine tests, and physical examinations, may be required. You will also be provided with your study drug at visits.
If you choose to participate in a study, we encourage you to communicate freely with the study doctor and staff throughout the study. If you have questions or concerns about any aspect of the study, you should feel comfortable discussing them with the study doctor at any time.