Magnetic Stimulation as a Treatment for Stress Urinary Incontinence
This study aims to find out if a new treatment, called magnetic stimulation, can help women who experience stress urinary incontinence. This is a common problem where urine leaks out when you cough, sneeze, or laugh. The study will compare the magnetic treatment to a 'dummy' treatment (sham) to see if it's effective in reducing or stopping these leaks. Researchers will also look at how this treatment affects a woman's quality of life and overall satisfaction. Participants will be carefully monitored for two years to see the long-term effects of the treatment and if there are any problems. The goal is to discover if this magnetic stimulation could be a helpful option for women struggling with bladder control.
At a glance
What is this study about?
This study is about understanding if a treatment called magnetic stimulation can help women who have stress urinary incontinence (SUI). SUI is a common condition where everyday actions like coughing, sneezing, laughing, or exercising can cause accidental urine leaks. It happens because the muscles that support the bladder and urethra (the tube urine passes through) aren't strong enough.
The researchers want to see if strengthening these 'pelvic floor' muscles using magnetic stimulation can reduce or stop these leaks. To do this fairly, they'll divide women into two groups. One group will receive the actual magnetic stimulation, and the other will get a 'sham' treatment, which feels similar but doesn't have the active magnetic effect. This helps the researchers know if any improvements are truly due to the magnetic stimulation or just from the attention and care during the study. After three months, if women in the 'sham' group haven't improved, they'll have the chance to try the real magnetic stimulation.
Over the course of the study, researchers will compare how well both groups do in stopping or reducing their urine leaks. They'll also check for any side effects and see how the treatment affects women's daily lives and their happiness with the results. This research is important because it could lead to new and better ways to help women manage SUI, improving their comfort and confidence.
Key takeaways
- The study explores magnetic stimulation for stress urinary incontinence (SUI).
- It aims to reduce accidental urine leaks during activities like coughing/sneezing.
- Compares real magnetic treatment to a dummy (sham) treatment.
- Follows participants for up to two years to track results and safety.
- Could offer a new way to help women manage SUI and improve their daily lives.
Who may be eligible?
This study is looking for adult women who have stress urinary incontinence (SUI). You should have experienced leaks when coughing or sneezing for at least three months, and a doctor will need to confirm this with a simple test. Your bladder should be able to hold a reasonable amount of urine, and you shouldn't have too much urine left in your bladder after you go to the toilet.
There are some reasons you wouldn't be able to join. For example, if you are pregnant, breastfeeding, or plan to get pregnant during the study period. You also can't have this type of SUI if you have other main types of incontinence (like urgency leaks). Having certain medical conditions that affect your bladder, or if you have metal implants in your body between your belly button and knees (like pacemakers), would also prevent you from joining.
You also can't be currently having radiation or chemotherapy, or have had pelvic surgery or radiation in the last three months. If you are already trying another treatment for SUI, or are unable to attend appointments or follow instructions, you wouldn't be suitable for this study.
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 an adult woman with stress urinary incontinence (leaking with cough/sneeze)?
- Have you had SUI for at least 3 months?
- Are you not pregnant, breastfeeding, or planning a pregnancy during the study?
- Do you have no metal implants between your belly button and knees, or a pacemaker?
- Do you not have other main types of incontinence (e.g., urgency leaks)?
- Are you able to attend appointments and follow instructions?
What does participation involve?
If you decide to take part, you'll first have a medical check-up to make sure the study is right for you. Then, you will be randomly assigned to one of two groups: either you'll receive the actual magnetic stimulation treatment, or you'll receive a 'sham' (dummy) treatment for a period. This is vital so researchers can compare the real treatment to no active treatment, without you knowing which one you're getting at first.
Around three months after your treatment, the researchers will check your progress. If you were in the 'sham' group and haven't improved, you might then have the option to receive the actual magnetic stimulation treatment. Your progress will be monitored regularly, and you'll have check-ups to assess your symptoms, quality of life, and any new issues. The researchers will continue to follow up with you for up to two years after your treatment.
Potential risks and benefits
Locations (1)
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada
Common questions
What is 'stress urinary incontinence'?
It's when you accidentally leak urine during activities like coughing, sneezing, laughing, or exercising, due to weakened pelvic floor muscles.
What is magnetic stimulation?
It's a treatment that uses magnetic pulses to strengthen the muscles in your pelvic floor, which help control your bladder.
What does 'sham treatment' mean?
It's a dummy treatment that looks and feels like the real thing, but doesn't have the active magnetic effect. This helps researchers compare the real treatment fairly.
How long will I be involved in the study?
You'll have an initial treatment period, and then researchers will follow your progress for up to two years.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without giving a reason, and it won't affect your regular care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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