Bulkamid to treat stress urinary incontinence

Bladder leaking is common.  We think that more than 1/3 of women leak.  It becomes more common (but never normal) as we age.  The population is getting older- this means that an even larger number of women will be leaking in the next decades.  Companies have recognized that this is a large market.  And this has spurred research, innovation, and new products.  This is all very exciting for me and my urogynecology world because it means that there are more treatment options to discuss.

Urethral bulking

One treatment for stress urinary incontinence (leaking with coughing, sneezing, exercise, etc.) is urethral bulking.  In this procedure, we take a material and inject it into the urethra.  This plumps up the urethra (think of it as lip filler but for the urethra) and makes it much harder to leak.  It rarely impacts how well you empty.  This is an easy procedure, and we often do it in the office with a bit of numbing medication.

When I first started training, we would inject collagen into the urethra as filler.

Before doing this, we would have to test for an allergic reaction.  The collagen worked but would wear off after about two years.  Repeat injections could be done, but they didn’t work as well after the second or third injection.  New products were developed over time, but they all wore off after about two years.  Because of this durability issue, we used this treatment mostly in older women.

In 2020, the FDA approved a new gel material (polyac,rylamide hydrogel, to be exact).

This material has been used in Europe for much longer and is commercially known as “bulkamid” in the US.  This material is proving to last much longer and is more effective.  And because of this, it is a reasonable option for a large range of patients.  So, let’s review the data here.

In 2021 a study from Germany about bulkamid was published.  They questioned patients about their leaking and their satisfaction with the procedure SEVEN years after it was done.  These results don’t mean that the material fails at seven years. This was just when we asked the questions.  1200 women had had the procedure, and about 33% answered their questions.  67% of women felt cured or much better seven years after bulkamid IF it was their first procedure.  Only 61% felt cured or much better if it was their second procedure.  Around 20% of women went on to get another procedure or surgery for their leaking.

When you consider how easy this procedure is, these are great results.  It is just an injection- there are no knives, cutting, mesh or sewing.  The recovery time is minimal.  There are very few risks as well.  In this study, about 3% of women got a bladder infection.  And 15% had trouble emptying their bladder for a few days.  These issues were easily corrected.  This data supports the efficacy and longevity of this procedure.  I would love to see more work on how long it can last.

Comparing bulkamid to the TVT

One of the questions I always have is how one procedure compares to another.  These studies are expensive and are rarely done.  Companies don’t always want to know what works better.  But a recent study compared bulkamid to the TVT.

The TVT is a brand of retropubic midurethral (mesh) sling.  It has been used for decades in the US and is considered (with other brands of retropubic midurethral slings) to be the “gold standard” or best treatment for stress urinary incontinence.  It works really well.  But nothing is perfect.

When we use mesh, there can be mesh complications.

These are rare (happen less than 2% of the time) and are easily treatable, but they are a nuisance for women.  It is also preferable to use a sling when someone is done having children, so they aren’t a great option for younger women with leaking issues.  A sling is also a surgery with some required recovery time.  And surgery can be expensive.

This study was a randomized controlled trial (the best kind of study).

They found that the mesh sling worked better than the bulkamid.  Cure rates for the mesh sling were 95% and 66% for the bulkamid.  But complications were higher in the sling group.  And some women in the sling group had to have a second surgery (for bleeding and mesh complications).  No one in the bulkamid group had to have a second surgery or had a complication more serious than a bladder infection.  And 88% of the bulkamid patients would pick this treatment again.  92% of the bulkamid patients would recommend the treatment to a friend.  These are really strong indicators of satisfaction.  No woman recommends anything less than great to her friends.

So the take-home message?  Bulkamid is a good option to treat stress urinary incontinence.  It doesn’t work as well as a mesh sling, but there are fewer complications.  And women are generally happy with their results.  If bulkamid doesn’t solve the problem, we can always move on to more invasive things.

It is really exciting to have new treatments.  It helps me tailor the treatment to the individual.  Some companies are even advertising their products on TV.  And while their treatment may not be the right one for you, it does normalize bladder leaking.  It gets the conversation started.  It makes you realize how common this all is.  And that is a very good thing.

Brosche T Neurourol & Urodyn 2021

Itkonen Freitas J Urol 2020