Active not recruitingNAINTERVENTIONAL

Laser Vaginal Treatment for GSM

This study is investigating a new laser treatment for symptoms that many women experience after menopause. These symptoms, often called Genitourinary Syndrome of Menopause (GSM), can include vaginal dryness, itching, discomfort during sex, and even bladder problems like needing to go to the toilet urgently or having pain. They happen because of lower hormone levels. While there are treatments available, finding one that works well and is easy to stick with long-term can be a challenge. This research aims to compare the new laser treatment with existing options to understand if it's an effective way to help women feel more comfortable and improve their quality of life. The study will be a 'randomised controlled trial', which is a good way to test new treatments fairly.

At a glance

Status

Active not recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

01 Aug 2019

Estimated completion

31 Oct 2027

Menopausal Urethral Atrophy Vulvar Atrophy

What is this study about?

Many women experience uncomfortable vaginal and urinary symptoms as they go through menopause or afterwards. These symptoms, sometimes called Genitourinary Syndrome of Menopause (GSM), are often caused by lower levels of a hormone called oestrogen. They can include things like vaginal dryness, itching, feeling sore or uncomfortable, and pain during sex. Some women also find they have bladder irritation, painful urination, or more frequent bladder infections.

Currently, treatments often involve using vaginal moisturisers, lubricants, or oestrogen creams and tablets. While these can be helpful, some women might find them expensive long-term or simply prefer not to use creams or inserts regularly. This study is exploring a new approach: a laser treatment that might help improve these symptoms.

Researchers want to see if this laser treatment is a good option for women dealing with these menopausal symptoms. By setting up a careful study, they aim to find out how effective it is and whether it could offer a lasting solution for women, helping to improve their comfort and overall well-being.

Key takeaways

This study is testing a new laser treatment for common post-menopausal symptoms.
It aims to help women with vaginal dryness, discomfort, and bladder issues.
Researchers want to see if the laser is a good alternative to creams or moisturisers.
The study is a careful comparison to find out how effective this new treatment is.
Participation involves receiving the treatment and being monitored for a few months.

Who may be eligible?

To join this study, you need to be a woman between 45 and 70 years old. You must have gone through menopause at least two years ago, either naturally or if you've had surgery to remove both ovaries. You should also be experiencing at least one bothersome vaginal symptom, such as dryness, itching, irritation, soreness, or pain during sex, for the last month, and these symptoms should be moderate or severe at least once a week.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you have any unexplained bleeding from your vagina. You also can't have an active vaginal or bladder infection, or have taken antibiotics in the last month. If you're already undergoing other new treatments for your symptoms, or if you've had certain surgeries recently, you might not be suitable.

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 between 45 and 70 years old?
Have you been through menopause (natural or surgical) for at least two years?
Do you have moderate to severe vaginal symptoms (dryness, itching, irritation, soreness, or painful sex) at least once a week for the last month?
Are you able to follow study instructions?
Are you NOT pregnant or breastfeeding, and don't have any unexplained vaginal bleeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the laser vaginal treatment. The study will monitor your symptoms for a period that includes the treatment time and for three months afterwards. You won't be able to start any new treatments for your menopausal symptoms during this time, to make sure the researchers can clearly see the effects of the laser. Details about the number of visits, specific assessments, and the overall duration of your participation will be fully explained by the study team if you are eligible and interested.

Potential risks and benefits

Participating in this study might offer you a potential benefit by improving your vaginal and urinary symptoms through a new laser treatment. However, as with any medical procedure, there could be some risks or side effects that the study team will explain carefully. You will be given full information about these during the consent process. Remember, joining any study is completely voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (1)

Sunnybrook Health Sciences Centre, University of Toronto
Verified postcode
Toronto, Canada

Common questions

What kind of symptoms is this laser treatment for?

It's for symptoms like vaginal dryness, itching, irritation, soreness, painful sex, and bladder problems that can happen after menopause.

How does the laser treatment work?

The study is investigating how a new laser treatment can help improve these menopausal symptoms. More detailed information will be provided by the study team.

Will I have to stop my current treatment if I join?

You cannot be on any *new* treatments for these specific symptoms during the study and for three months afterwards. The study team will discuss this with you.

Who is running this study?

This is a randomised controlled trial, which is an independent scientific study designed to fairly test new treatments.

What happens after the study ends?

The study aims to see how effective the laser is for your symptoms during the three-month follow-up period. Further care options would then be discussed with your doctor.