RecruitingOBSERVATIONAL

Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire

This study is investigating how treatments for breast cancer and gynaecological (female reproductive organ) cancers can sometimes affect a part of the body called the pelvic floor. The pelvic floor is a group of muscles that supports your bladder, bowel, and womb, and plays a role in sexual function. When these muscles don't work as well, it can impact a person's quality of life. Researchers will use special questionnaires to understand how treatments might change bladder, bowel, or sexual function. They also want to identify factors that contribute to these changes. The goal is to find better ways to prevent or treat these issues in the future, helping patients feel more comfortable and improve their overall well-being.

At a glance

Status

Recruiting

Sponsor

St. Josefs-Hospital Wiesbaden GmbH

Enrolment target

200

Start

01 Apr 2018

Estimated completion

31 Dec 2026

Pelvic Floor Disorders

What is this study about?

When someone is treated for breast cancer or cancers of the female reproductive organs, like the womb or ovaries, they often receive different kinds of treatments. While these treatments are vital for fighting cancer, they can sometimes have side effects on other parts of the body, including the pelvic floor. The pelvic floor is a group of muscles at the bottom of your pelvis that supports your bladder, bowel, and uterus (womb), and is important for controlling when you go to the toilet and for sexual activity.

Changes to the pelvic floor can mean experiencing problems like leaking urine (pee) or struggling with bowel control, or changes in sexual function. These issues can be upsetting and affect how a person feels day-to-day. This study aims to understand these problems better by asking patients about their experiences using specific questionnaires. These questionnaires are designed to help researchers measure how well the pelvic floor is working and if there are any difficulties.

By gathering this information, researchers hope to learn more about how treatments for breast and gynaecological cancers might impact the pelvic floor and what other factors could be involved. Their ultimate goal is to use this knowledge to develop new and better ways to help prevent these problems from happening or to treat them if they do occur. This could significantly improve the quality of life for many cancer patients.

Key takeaways

This study focuses on pelvic floor health during cancer treatment.
It's for people receiving treatment for breast or gynaecological cancer.
Participation involves answering questionnaires about bladder, bowel, and sexual function.
No new treatments or medications are given during the study.
The goal is to improve prevention and treatment for pelvic floor issues in cancer patients.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. You would be considered if you are currently receiving treatment for breast cancer or for a gynaecological cancer (cancer affecting the female reproductive organs).

There are no specific reasons why you would not be able to join this study, other than not meeting the above criteria. The study welcomes all genders who meet the cancer treatment requirements.

Essentially, if you are an adult undergoing treatment for either breast cancer or a gynaecological cancer, you might be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently receiving treatment for breast cancer?
Are you currently receiving treatment for a gynaecological cancer (like ovarian, womb, or cervical cancer)?
Are you comfortable answering questions about your bladder, bowel, and sexual health?

Answer every question to see your result.

What does participation involve?

This study involves answering questions using special forms, known as validated questionnaires. These questionnaires will ask about your pelvic floor function, covering topics related to your bladder, bowel, and sexual health. You won't be given any new medications or treatments as part of this study. You will simply be sharing your experiences through these forms. The study does not specify doctor visits or a long follow-up period, suggesting it mainly involves completing these questionnaires. The total duration of your participation would depend on how many questionnaires are involved and over what period, but it's focused on your current experience during treatment.

Potential risks and benefits

A potential benefit of joining this study is that your contribution will help researchers better understand how cancer treatments affect the pelvic floor. This knowledge could lead to better ways of preventing or treating these issues for future patients. While there are no expected physical risks from simply filling out questionnaires, some questions might cover sensitive personal topics, which could be uncomfortable for some individuals. Remember, you have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

St. Josefs-Hospital Wiesbaden GmbH
Verified postcode
Wiesbaden, Germany· Recruiting

Common questions

What is the 'pelvic floor'?

The pelvic floor is a group of muscles at the bottom of your pelvis. They support your bladder, bowel, and womb, and help you control when you go to the toilet.

Why is this study important?

It helps researchers understand how cancer treatments might affect your pelvic floor. This knowledge can lead to better ways to prevent or treat problems, improving quality of life.

Will I receive new treatments?

No, this study is about understanding your experiences with your current cancer treatment. You won't be given any new medications or therapies.

What does a 'questionnaire' involve?

It's a set of questions you answer about your health and experiences, specifically about your bladder, bowel, and sexual function.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time. It will not affect your medical care.

How to find out more

Boris Gabriel, Prof. Dr. med.

bgabriel@joho.de +496111771500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.