For those of you suffering from stress or urge-induced urinary incontinence, implantable devices might be your new savior.
In this post, we will discuss 3 main types of minimally invasive treatment options to consider when conventional treatments like weight loss and pelvic floor exercises have failed – injectables, sling surgery, and implantable devices for both stress and urge induced urinary incontinence. The option you choose will mostly depend on the cause of your Urinary Incontinence and other personal factors like durability, convenience, family planning, longevity, etc.
Here’s a quick summary: Gynecare TVT has proven to be the most effective in all sling procedures, producing “lasting results” with “85-90%” success rates whilst being “minimally invasive”. But it shouldn’t be done if you plan to give birth in the future. As for implantable devices, Interstim II takes the cake, since it’s the “tiniest device”, does not need to be charged for up to “5 years” and doesn’t “interfere” with your future pregnancies. As for injectables, Bulkamid has shown to be a “safe” and “durable” option to treat stress-induced incontinence, producing a success rate of “80%”. But you may need “multiple treatments” to see lasting results.
| Type | Recovery time | Incision | Post Operative Complications/Side effects | Lasting Results | |
|---|---|---|---|---|---|
| Gynecare TVT | Sling | 6 weeks | Yes – 2 | difficulty urinating, injury to blood vessels, bladder and bowl. | 7+ years |
| Solyx™ | Sling | 1-2 weeks | Yes | Minor pain, light vaginal bleeding, abdominal cramping. | 5 years |
| Supris® | Sling | 1-2 weeks | Yes – 2 | Adhesions, bleeding, erosion, bowel issues. | 5 years |
| KIM | Sling/ Mesh without Knots | 1-2 weeks | Yes – 1 | Pain, erosion, UTI, scarring, bleeding, bowel issues. | 5 years |
| Desara® One | Sling | 2 weeks | Yes – 1 | Infection, erosion, inflammation, adhesions. | 5 years |
| Obtryx II | Sling | 1-2 weeks | Yes – 2 | Pain, Mesh erosion, pain during intercourse | 3 years |
| Altis | Sling | 1-2 weeks | Yes – 1 | Pain, erosion. | 8 years |
| Aris | Sling | 1-2 weeks | Yes – 2 | Pain, erosion. | 3 years |
| Needleless | Sling | 1-2 weeks | Yes – 1 Tiny | Bladder perforation and stone formation on mesh. | 3 years |
| Macroplastique | Injectable silicone implants | 1-2 weeks | No | Pain, blood in urine, painful urination, UTI. | 3 years |
| Bulkamid | Injectable hydrogel | 1 day | No | Struggle emptying bladder | 7 years |
| InterStim II | Implantable Device | 6 weeks | Yes – 1 | Pain, infection, bowel changes, undesirable stimulation. | 5 years |
| Axonics | Implantable Device | 3 weeks | Yes – 1 | Minor discomfort | 15 years |
Imagine leaking a little every time you laugh, cough or sneeze. That’s a daily struggle for people suffering from Urinary Incontinence.
Urinary incontinence is the loss of bladder control, leading to urinary leakage. It’s something that up to 50% of women go through at some point in their life, while 10-20% suffer from bothersome leakage. Urinary incontinence in women can be categorized into two types: stress incontinence and urge incontinence, which is also known as an overactive bladder.
Before we proceed, we need to voice something rather important: urinary incontinence is not a normal part of aging. Yes, it is concerning. But it can also be treated.
So the first thing you should do is get a thorough checkup from your health care provider to determine if you are suffering from urinary incontinence, and if so, what type it is. It could be:
Stress incontinence: urine leaks when pressure is exerted by coughing, sneezing, laughing, etc.
Urge incontinence: sudden, intense urge to urinate often followed by involuntary urine leakage, especially throughout the night.
Mixed incontinence: A combination of more than one type of urinary incontinence.
Initially, you may be recommended the following lifestyle modifications which include:
Weight loss.
Fluid management, which includes cutting back on fluids to reduce leakage.
Pelvic muscle or Kegel exercises to strengthen the muscles that control urine leakage.
Your healthcare provider may also recommend supervised pelvic floor physical therapy or using vaginal pessaries. A pessary is a flexible device made out of silicone and is worn in the vagina to support the urethra and treat stress incontinence.
While these noninvasive treatments can work for some, it is quite common for them to be ineffective for others. So, what would be the next step?
Then, it’s time to consider other more innovative procedures – exactly what this post is all about.
There are a ton of options that you can choose from, but you don’t have to feel overwhelmed. We’ll mention all the details: the procedure, durability, and so much more. By the end of this, you’ll have everything you need to know to make the best decision for yourself.
Sling Surgery Options
1. Gynecare TVT
(Ethicon US, LLC, Bridgewater, NJ, USA, and Cincinnati, OH, USA, a Johnson & Johnson company)
One of the most common surgeries to treat stress incontinence is sling surgery. Sling surgery is widely known to be effective and can dramatically improve the quality of life. Gynecare TVT involves a sling procedure using 2 tiny incisions starting near the urethra and coming out through the abdominal wall. But it is still a short procedure and can be performed under local, regional, or general anesthesia. The risks include difficulty urinating, injury to blood vessels of the pelvic sidewall and abdominal wall, and bladder and bowel injury.
A huge plus point with Gynecare TVT is that it is the only treatment of its kind with demonstrated long-term clinical results. 98% of women claim that they are still dry or experience significantly reduced leakage even seven years after the treatment.
2. Solyx™ Single Incision Sling System
(Boston Scientific Corp., Marlborough, MA, USA)
What happens in a single-incision method, your surgeon will make one small cut in your vagina and put in a ‘sling’ made out of mesh or human tissue that is put under the urethra as a means to support it and the neck of your bladder.
The procedure is done with anesthesia, so it’s painless. The recovery period is about a week or two. Post-operative effects can include minor pain at the incision site, abdominal cramping, or light vaginal bleeding for a week or two.
If the sling is improperly placed or shifts over time, it can be removed or replaced. Therefore, this option is reversible and will not stop you from other procedures in the future.
3. Supris®
(Coloplast Corp., Minneapolis, MN, USA)
The Supris Retropubic Sling System is a mid-urethral sling indicated for the surgical treatment of all types of female stress urinary incontinence. Retropubic slings pass underneath the middle of the urethra and then run in front of the bladder. Like Gynecare TVT, this procedure also involves two small incisions.
Patients are discharged within a few hours, as soon as they’re able to empty their bladder. If, however, you struggle with emptying your bladder, you might be asked to stay a night or two. It’s always recommended to drink lots of water and eat fiber-rich foods to avoid constipation to have a smooth recovery.
Despite being on the market since 2011, there is not a lot of scientific evidence supporting its efficacy.
4. Knotless Incontinence Mesh (KIM)
(Neomedic International, Terrassa, Spain)
Incorporating the same sling system like the others, what sets KIM® apart is that it is the only mesh available with no knots. The absence of knots makes the mesh macroporous (not microporus within the knots) and hence less susceptible to infection. The sling also has smoother edges than other slings, thus facilitating a painless placement and lesser risk of tissue erosion. Studies have supported the fact that the KIM system might be beneficial in terms of reducing post-operative complications.
5. Desara® One
(Caldera Medical, Agoura Hills, CA, USA)
A single-incision sling system, the Desara One is part of the Desara Family of Products, all dedicated to the treatment of female stress urinary incontinence. It incorporates an anchor that is fully integrated with the mesh, which prevents ripping, twisting, and roping. Its blue mesh ensures that the sling maintains its shape after placement, reduces inflammatory responses, and encourages tissue in-growth.
There are multiple studies that are being conducted currently to assess the effectiveness of the Desara One, which means that this treatment will soon have evidence to support it.
6. Obtryx II
(Boston Scientific Corp., Marlborough, MA,USA)
This procedure targets stress urinary incontinence and includes a transobturator sling, which is inserted through the groin and away from other organs. Conducted with anesthesia and lasting about 30 minutes, two incisions are made; one in the vagina under the urethra and one in each groin. While the Obtryx II is safer, it does pose a higher risk for mesh erosion and pain over the long-term, including during intercourse.
In a study, when Obtryx II was compared to the Solyx Single Incision Sling System, it was found that they both had similar rates of adverse events.
Altis
(Coloplast Corp., Minneapolis, MN, USA)
Another transobturator sling, the Aris consists of a polypropylene sling that is sheathless and minimizes tissue disruption. Similar to the Obtryx II, it too targets stress urinary incontinence. It guarantees stable results beyond 3 years and low complications.
Aris
(Coloplast Corp., Minneapolis, MN, USA)
Another transobturator sling, the Aris consists of a polypropylene sling that is sheathless and minimizes tissue disruption. Similar to the Obtryx II, it too targets stress urinary incontinence. It guarantees stable results beyond 3 years and low complications.
Needleless
(Neomedic International, Edina, MN, USA)
First of its kind, Needleless is the single incision sling that is placed with no anchors and no skin incisions. It incorporates a patented pocket positioning system and can be performed with local anesthesia. So, if you’re looking for a minimally invasive treatment that leaves no marks and scars, this is a viable option for you.
Urethral Bulking Agents
Macroplastique
(Cogentix Medical, Inc., Minnetonka, MN, USA)
In this procedure, tiny silicone implants are injected into the tissues as a bulking agent. The increased bulk enables the urethra to close more effectively, thus preventing urine leakage. Local anesthesia is administered and the procedure is approximately 30 minutes long.
Given that it’s minimally invasive, you can expect to resume your daily activities after a couple of days. Risks include pain due to the procedure, minimal amounts of blood in urine, painful urination, and urinary tract infection. You might also need more than one injection. However, with a successful Macroplastique procedure, you will have significantly reduced episodes of urinary leakage or even become fully free of them.
It is possible for the symptoms to not improve or to return after the treatment. In that case, you can easily get other treatments, as Macroplastique doesn’t prevent that.
Bulkamid
(Axonics Modulation Technologies, Inc., Irvine, CA, USA)
This procedure is injection-based, where a hydrogel – a thick, permanent gel – is injected into the wall of the urethra, which adds volume to it and provides support and better control of the urine flow.
The procedure is merely 10-15 minutes long; but is known to show lasting results.
However, research does show that it isn’t as effective as mesh slings, which is why you might need multiple injections for the treatment to be successful.
There is also the risk of struggling to empty your bladder, upon which you might be fitted with a temporary catheter to solve the issue. It is also important to note that this procedure should not be performed if you already have a urinary tract infection.
Implantable Device Options
InterStim
(Medtronic plc., Dublin, Ireland)
With InterStim Therapy, an implantable device sends mild electrical pulses to the sacral nerves, which control the bladder and help relieve symptoms of urinary incontinence. Before the procedure, the patient can always opt for a minor test to see if the procedure works, which is known as Interstim Stage 1.
For the test, a small skin puncture is done and small wires are placed down the bladder nerves. The process takes about 10 minutes, after which you’re sent home to observe the results for about a week. Patients are to log their symptoms through this period. If the test is successful, you can then opt for a permanent implant, which is Interstim Stage 2.
This procedure takes 30 minutes, where a small battery and soft wire are implanted under the skin of the upper buttock. Both the testing and full procedure are performed under sedation, hence they are painless.
Once the procedure is completed, your surgeon will then program the device’s electrical signals based on the results from the test period. As the battery doesn’t last forever, this device needs to be replaced periodically. Newer versions of this product continue to be developed, each with progressively longer battery life.
The InterStim is used with two devices: InterStim Micro and InterStim II. The major difference between the two is that the InterStim II is a recharge-free system, offering patients freedom from a hasslesome recharging routine and recharging components. It is also the smallest Sacral Neuromodulation device available in the market.
This procedure is known to significantly improve your quality of life and is a long-term solution, majorly for those patients who have tried and not succeeded with conservative treatment. It is also generally covered through most insurance plans, which thus makes it a cost-effective treatment option. Some more benefits of the InterStim device is that it is full-body MRI compatible, and completely and easily reversible.
Axonics
(Axonics Modulation Technologies, Inc., Irvine, CA, USA)
Similar to InterStim, Axonics Therapy works by stimulating the sacral nerves with electrical pulses. It also includes a trial period and evaluation, which if successful, is followed by the surgery where the device is implanted permanently. It too is removable and full-body MRI compatible. Axonics Therapy is specifically for urge incontinence, and is not ideal for patients who suffer primarily from stress incontinence.
Now let’s compare it to InterStim Micro and InterStim II.
Sizes: Interstim Micro is about the size of a silver dollar; Axonics about the size of a quarter; InterStim II is the smallest device available.
Charging: InterStim Micro needs to be charged every week for about 20 minutes; Axonics for about an hour every month; InterStim II doesn’t require recharging at all.
Replacement: Both InterStim Micro and Axonics claim their batteries will last 15 years, although there are no real world studies to validate these claims; InterStim II needs to be replaced about every 5 years.
So other than the replacement frequency, InterStim II is the clear winner.
Frequently Asked Questions
Are there any new treatments for female incontinence?
Electrical stimulation
To stimulate and strengthen pelvic floor muscles, electrodes are temporarily implanted into your rectum or vagina. Gentle electrical stimulation can be useful for stress and urge incontinence, although many treatments over several months may be required.
What is the number one treatment for urinary incontinence?
If you’ve been diagnosed with urge incontinence, bladder training may be one of the first therapies you’re recommended. If you have mixed urine incontinence, bladder training can be paired with pelvic floor muscle training.
What are the three major categories of treatment for incontinence?
The three major treatment categories are behavioural, pharmaceutical, and surgical. Behavioural approaches may include any of the following: Scheduling Toileting – Every two to four hours, the carer reminds the incontinent patient to use the restroom. This establishes a regular voiding routine for the patient.
What drug classes treat urinary incontinence?
Anticholinergic medications, antispasmodics, and TCAs are the three primary types of pharmaceuticals used to treat urge incontinence.
Things To Consider
Before opting for any option, it’s important to have a detailed discussion with your doctor. Feel free to ask why they recommend an option and why they’re against the other. Talk about which treatment will work most effectively for the type of urinary incontinence you’re suffering from. Keep in mind that all the options we mentioned are FDA-approved, which informs you of their safety. Do not agree to a treatment that is not FDA-approved.
If a sling procedure seems right to you, Gynecare TVT is known to have the most evidence to support its efficacy. If you’re looking for injection-based, then Bulkamid is known to have long-lasting effects. And if you’re going for neurostimulation, then the device with the most favorable profile is the InterStim II.
Also keep in mind that things can go wrong. We’ve mentioned the potential risks that come with each treatment. For instance, if painful sexual intercourse is a no-go, be aware that a transobturator sling such as Aris or Obtryx II may not be right for you. If you’re looking to not consistently be reminded of your condition, then consider opting for the recharge-free InterStim II. Not only does it not show, but you also don’t have to worry about recharging it. However, if the quicker replacement time is bothersome for you, you can go for Axonics. Just make sure to discuss with your doctor all the potential downsides, outcomes and factors mentioned in the table.
There are so many things you need to factor in when making your decision and we hope we’ve made it easier for you.
Selected References
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