Active not recruitingNAINTERVENTIONAL

RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women with Recurrent Urinary Tract Infections

This research study is for women who have gone through menopause and frequently suffer from urinary tract infections (UTIs). Many women find that after menopause, hormone changes can make UTIs more common. The study wants to investigate if a laser treatment applied gently inside the vagina, which aims to improve vaginal health, can help reduce how often these UTIs occur. We are comparing this laser treatment with a 'sham' treatment (a dummy treatment that feels similar but isn't the active laser) to see if the laser makes a real difference. Researchers will also look at how this treatment affects the natural balance of bacteria in the vagina.

At a glance

Status

Active not recruiting

Phase

Sponsor

King's College Hospital NHS Trust

Enrolment target

Start

01 Oct 2023

Estimated completion

08 Oct 2026

Recurrent Urinary Tract Infection Genitourinary Syndrome of Menopause

What is this study about?

Many women, especially after menopause, can experience changes in their body that make them more likely to get urinary tract infections, or UTIs. This is often part of a wider issue called Genitourinary Syndrome of Menopause (GSM), which describes a range of symptoms caused by lower hormone levels. These changes can include the thinning of sensitive tissues in the genitourinary area and shifts in the helpful bacteria found there, both of which can make UTIs return again and again.

While there are some treatments for frequent UTIs, they don't always work for everyone. Laser treatment inside the vagina has shown promise for treating other symptoms of GSM by helping to restore the health of the vaginal tissues. However, we don't yet know if it can specifically help with recurrent UTIs. We believe that by improving the health of the vaginal lining and encouraging good bacteria, this laser treatment might make it harder for the bad bacteria that cause UTIs to thrive.

This study aims to find out if this vaginal laser therapy can reduce the number of UTIs in post-menopausal women. To do this, we'll compare the laser treatment to a 'sham' treatment – a procedure that looks and feels like the real thing but doesn't deliver the active laser. This helps us ensure that any improvements seen are truly due to the laser and not just a placebo effect. We will also be looking closely at how the treatment affects the natural bacteria in the vagina, which could give us clues about how it works.

Key takeaways

This study is for post-menopausal women with frequent UTIs.
It tests a special vaginal laser treatment against a dummy (sham) treatment.
The goal is to see if the laser can reduce UTIs and improve vaginal health.
Participation involves clinic visits and lasts about 17 months.
You won't know if you're getting the real laser or the sham treatment.
Your involvement could help many women with recurrent UTIs in the future.

Who may be eligible?

This study is looking for women who have already gone through menopause. You would need to have a history of frequent urinary tract infections. This typically means you've had at least three UTIs in the last year, or two within the past six months, or you've had a UTI that needed hospital care. If you've been taking antibiotics regularly to prevent UTIs, you would need to have stopped them for at least three months before joining.

There are also some reasons why you might not be able to join. For example, if you've recently used hormonal creams or tablets in your vagina (in the last three months), or if you have certain existing medical conditions or infections. You also wouldn't be able to join if you use catheters, have unexplained vaginal bleeding, or have had certain types of surgery or radiation therapy in the past. Above all, you must be willing and able to participate in the study for its full duration and understand what's involved.

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 has already gone through menopause?
Have you had at least three UTIs in the last year, or two in the past six months?
Are you able to attend clinic visits for about 17 months?
Have you avoided using hormonal vaginal treatments in the last three months?
Do you not have an active vaginal infection or certain medical conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in the study for about 17 months in total. You would be randomly assigned to receive either the active intravaginal laser treatment or a 'sham' treatment, which feels similar but isn't the real laser. Neither you nor your immediate care team would know which treatment you are receiving. The study involves several visits to the clinic for treatments and follow-up checks. During these visits, there will be assessments to see how you are doing and to check for any UTIs. You might also be asked to provide samples to help researchers understand the impact on vaginal health. You'll need to follow specific instructions, including avoiding vaginal intercourse for 48 hours after any laser treatment sessions.

Potential risks and benefits

Taking part in this study could potentially reduce your number of UTIs and improve your vaginal health, especially if the laser treatment proves effective. However, there's no guarantee you will personally benefit from the treatment. As with any medical procedure, there's a possibility of side effects or discomfort, though current information suggests this laser treatment is generally safe for similar uses. By participating, you would be helping researchers learn more about new ways to treat recurrent UTIs, which could benefit many women in the future. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

King's College Hospital
Verified postcode
London, United Kingdom

Common questions

What is menopause?

Menopause is when a woman's periods stop permanently, usually around the age of 45-55. It marks the end of her reproductive years.

What is a 'sham' treatment?

A 'sham' treatment is like a dummy treatment. It's done in a way that makes you feel like you're getting the real treatment, but it doesn't contain the active ingredient or device. This helps us fairly compare it to the actual treatment.

What is a recurrent UTI?

A recurrent UTI means you keep getting urinary tract infections, typically having three or more in one year, or two or more in six months.

Will I know if I'm getting the real laser or the sham treatment?

No, this is a 'single-blinded' study, meaning you won't know which treatment you are receiving. This helps make the study results more reliable.

Is the laser treatment painful?

The information suggests the treatment is generally safe and effective for other conditions, but personal experiences can vary. You can discuss any concerns about discomfort with the study team.