RecruitingOBSERVATIONAL

Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

This research trial is studying a new treatment for a common condition called pelvic organ prolapse, specifically when the womb drops down (uterine prolapse). The treatment involves a device called Splentis, which is put in through the vagina to help lift and support the womb. We want to see how good this treatment is at fixing the prolapse and if it causes any problems over a long time – about five years. We're also looking at how it affects things like bladder control, quality of life, and sex life. This study is for women who haven't had children recently and are having this specific surgery for the first time.

At a glance

Status

Recruiting

Sponsor

Promedon

Enrolment target

140

Start

19 Dec 2022

Estimated completion

01 Jul 2030

Pelvic Organ Prolapse

What is this study about?

You might be reading this because you're experiencing something called pelvic organ prolapse, which is a common condition where organs like the womb, bladder, or bowel drop down from their usual position. This study is focusing on a particular type called uterine prolapse, which is when the womb (uterus) drops into or out of the vagina.

Doctors are testing a new way to treat this using a special device called Splentis. This device is put in during a minor operation through the vagina and helps to lift and hold the womb back in place. The main goal of this study is to see how well the Splentis device works to fix the prolapse and if it's safe to use over a long period. Researchers will follow participants for five years to understand the long-term effects. This is a "first-time" treatment for uterine prolapse, meaning they are looking at women who haven't had this specific problem before.

Beyond just fixing the prolapse, the study will also look at how this treatment affects your daily life. This includes things like how well your bladder works, whether you have any leaks, how your quality of life changes, and how it impacts your sexual health. They will also keep a very close eye on any side effects or problems that might come up, ensuring your safety throughout the study.

Key takeaways

This study evaluates a new treatment (Splentis) for a dropped womb.
It aims to check how well the treatment works and if it's safe over five years.
The study is for women experiencing uterine prolapse for the first time.
It also looks at how the treatment affects bladder control, quality of life, and sexual health.
You'll have regular follow-up appointments for five years if you take part.

Who may be eligible?

This study is looking for women who have never had children recently (meaning they are past their childbearing years or have chosen not to have more children). You should be experiencing a noticeable drop of your womb (uterine prolapse) for the first time, and it should be causing you symptoms. Importantly, you must be planning to have the Splentis procedure to fix this issue.

You won't be able to join the study if you are still able to have children. Also, if your prolapse has happened before and come back, or if you've had a hysterectomy (womb removal) and your upper vagina has dropped, this study isn't suitable. Other reasons you couldn't take part include having any active infections in your vagina, cervix, or womb, or if you've had or are having certain types of cancer or radiation treatment in the pelvic area.

Finally, if you know you are allergic to a material called polypropylene, which is used in the Splentis device, you would not be able to participate. You must also be willing and able to come to all the study appointments and give your informed consent, which means you understand what the study involves and agree 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 a woman who is no longer planning to have children?
Is this the first time you've experienced your womb dropping (uterine prolapse)?
Are you scheduled to have surgery with the Splentis device for your prolapse?
Do you not have any active infections in your vaginal or pelvic area?
Are you able to attend all study appointments over five years?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have the Splentis procedure to treat your uterine prolapse. The study team will then follow your progress for up to five years (60 months). During this time, you'll have regular check-ups where doctors will assess how well the treatment is working. They'll look at whether the prolapse has improved, ask you about any symptoms you might have like bladder problems, and how your quality of life is. You'll also be asked to complete questionnaires about your general well-being and sexual health. The team will carefully record any side effects or complications, no matter how small, throughout this entire five-year period.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving a new treatment for your prolapse that could improve your symptoms and quality of life. By monitoring your progress so closely, any potential issues will be identified quickly. However, as with any medical procedure, there are potential risks, including those associated with surgery and the possibility of side effects or complications from the Splentis device. All known risks will be fully explained before you decide to participate. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

DRK Hospital Chemnitz-Rabenstein
Verified postcode
Chemnitz, Germany· Recruiting
Helios Hospital Erfurt, Department of gynaecology
Verified postcode
Erfurt, Germany· Recruiting
University Hospital Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Clinic Kassel
Verified postcode
Kassel, Germany· Recruiting
St. Elisabeth Hospital
Verified postcode
Leipzig, Germany· Recruiting
University Hospital
Verified postcode
Mannheim, Germany· Not yet recruiting
Hospital Tettnang
Verified postcode
Tettnang, Germany· Recruiting

Common questions

What is 'pelvic organ prolapse'?

It's when organs like your womb, bladder, or bowel drop down from their normal position, often causing discomfort or other symptoms.

What is Splentis?

Splentis is a medical device used in surgery to help lift and support the womb when it has dropped down (uterine prolapse).

How long will I be followed in this study?

You will be followed for a full five years (60 months) after your surgery to see the long-term effects of the treatment.

Can I join if I've had prolapse before?

No, this study is only for women experiencing uterine prolapse for the very first time. If it's a 'recurrence' (it's come back), you wouldn't be eligible.

Will this affect my ability to have children?

This study is for women who are past their childbearing years or don't plan to have more children, so it's not designed for those still planning a family.

How to find out more

Philipp Schelhorn

trials.de@promedon.com 00498031900400 Official trial record

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