Not yet recruitingPHASE3INTERVENTIONAL

Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

This research is exploring if using vaginal oestrogen after surgery for pelvic organ prolapse (when organs slip down from their normal place) can lead to better recovery for women. Doctors are trying to figure out the best way to use this oestrogen cream, either twice a week or every day, for six weeks after the operation. This first stage of the study will help them understand how easy it is to find women who want to take part and how well the study works. They will check on women's well-being, how satisfied they are, and if there are any problems after their surgery over two years.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Queen's University

Enrolment target

180

Start

01 Oct 2025

Estimated completion

30 Sep 2029

Pelvic Organ Prolapse (POP)

What is this study about?

You're reading about a study that wants to improve how women recover after surgery for pelvic organ prolapse. Pelvic organ prolapse happens when organs like your womb, bladder, or bowel sag down from their usual spot. Surgery can fix this, but doctors are always looking for ways to make recovery even better and more comfortable.

This study is looking at vaginal oestrogen, which is a common treatment for some women, often used to help with symptoms after menopause. Researchers want to see if using a small amount of this oestrogen cream directly in the vagina for six weeks after surgery can help with healing, reduce discomfort, or improve how satisfied women are with their results. This is a "pilot" study, which means it's a smaller first step to make sure everything is set up correctly before a bigger study starts. They’ll be looking at how well women adapt to the treatment and if there are any difficulties during the study period.

Participants will be split into three groups: one group won't use vaginal oestrogen, another will use it twice a week, and the third group will use it daily. By comparing these groups, doctors hope to learn if vaginal oestrogen can make a positive difference after prolapse surgery and, if so, what the best way to use it might be. They’ll follow up with women for up to two years to see how they're doing.

Key takeaways

This study evaluates vaginal oestrogen after pelvic organ prolapse surgery.
It's a pilot study to check feasibility for a larger trial.
You might be in a group with no oestrogen, twice weekly, or daily use.
Follow-up appointments are scheduled for up to two years.
The aim is to find ways to improve women's recovery and satisfaction.
Participation involves questionnaires and careful monitoring of your health.

Who may be eligible?

This study is looking for women who are at least 18 years old and are planning to have surgery for pelvic organ prolapse. Specifically, you need to be having a type of surgery that fixes the top part of the vagina (called apical suspension), and it can be done through the vagina or abdomen, and use either mesh or your own body tissue. You should not have had previous surgery using mesh for prolapse before, and your surgery must not only involve fixing the front or back walls of the vagina. You also shouldn't be having surgery where the vagina is closed.

It's important that you are willing to complete questionnaires about your health and how you're feeling, and that you plan to stay in the area where the study is taking place for at least two years after your surgery. The doctors need to believe you can follow the study instructions reliably.

There are also some reasons why you wouldn't be able to join. These include if you have certain medical conditions or if you are pregnant. For example, if you have or have had certain cancers (like breast or womb cancer) that can be affected by oestrogen, or if you have severe liver problems or a history of blood clots, this study wouldn't be suitable for you.

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 aged 18 or over?
Are you having surgery to fix pelvic organ prolapse, specifically affecting the top of your vagina?
Are you willing to complete health questionnaires?
Do you plan to live in the study area for at least two years after surgery?
Have you *not* had previous prolapse surgery that involved using mesh?
Do you have any medical conditions, like certain cancers or severe liver issues, or are you pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a meeting where the study is explained, and you'll sign a consent form. This will happen within six weeks before your planned surgery. You'll also fill out some questionnaires about your health, either online, on paper, or by answering questions from the study staff.

Once enrolled, you'll be randomly put into one of three groups shortly before your surgery. One group won't use vaginal oestrogen, another will use it twice a week, and the third group will use it daily. You'll apply the oestrogen cream (if you're in one of those groups) from the day of your surgery for six weeks.

You'll have check-up visits after your surgery – at 6 weeks, 6 months, 1 year, and 2 years. During these visits, the study team will ask about your health, any changes, how you're feeling, and if you've had any problems or complications since your last visit. They’ll also ask about your satisfaction with the surgery and any symptoms you might have. Each visit will involve completing forms to gather this information.

Potential risks and benefits

Taking part in a study like this might offer a chance to learn more about your health and potentially lead to better recovery for you and other women after surgery. For some women, using vaginal oestrogen might help with healing and symptoms during recovery. However, like any medicine, vaginal oestrogen can have side effects, and for some women, it might not be suitable or could cause problems. The study will carefully monitor any side effects or complications. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Health Sciences Centre
Verified postcode
St. John's, Canada
Kingston Health Sciences Centre
Verified postcode
Kingston, Canada

Common questions

What is pelvic organ prolapse?

Pelvic organ prolapse is when organs like your womb, bladder, or bowel slip down from their normal position into your vagina.

What is vaginal oestrogen?

Vaginal oestrogen is a cream or tablet that contains a small amount of the hormone oestrogen, used directly in the vagina, often to help with dryness or discomfort.

What does 'randomised' mean in a study?

It means you're put into one of the study groups by chance, like flipping a coin, so it's fair and unbiased.

How long will I be in the study?

You'll be involved in the study for six weeks after surgery, and then have follow-up visits for up to two years.

Can I still get my usual medical care if I join the study?

Yes, taking part in the study will not affect your ability to receive all your normal medical care from your doctors.

How to find out more

Jessca Pudwell, MPH, MSc

jessica.pudwell@queensu.ca 613-549-6666 Official trial record

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