ACT® INTERNATIONAL

Adjustable Continence Therapy

Caution – The Uromedica ACT system is an INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE. The ACT System is not available for sale in the United States.

The Uromedica ACT system has received European CE Mark approval, Canadian licensing, and is listed on the Australian Register of Therapeutic Goods for treatment of stress urinary incontinence and is available for sale in Europe, Canada and Australia.

WHAT IS ACT?


The ACT system is implanted within your body to assist in the protection of accidental leaking of urine. This can occur during everyday activities such as coughing, sneezing or physical activity. Once implanted, only you will know it is there. While other devices require surgery for an adjustment, ACT can be adjusted in a brief office visit to better match your individual needs. ACT can be inflated, deflated or removed by your doctor if necessary. ACT is also a passive therapy meaning there is no need for you to manipulate the device at any time.
 

The ACT device consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure of approximately 30 minutes, the balloons are surgically placed on either side of the bladder neck. The fluid-filled balloons provide pressure and support which protects against accidental leaking of urine that can occur during a sneeze, cough, or physical activity. When you need to urinate, it will only require a normal amount of bladder effort. The balloon size can be altered through a small port located underneath the skin of the labia majora. 

IS ACT RIGHT FOR ME?


ACT may be right for you if: You suffer from stress urinary incontinence as a result of intrinsic sphincter deficiency or a previously failed surgery. You have not adequately responded to conservative treatments.




ACT MAY NOT BE RIGHT FOR YOU IF...


ACT may not be right for you if you have: + An active or systemic or urinary tract infection + A current pregnancy + Incontinence due to detrusor (bladder) instability or over activity + Reduced bladder compliance + Primarily urge incontinence + Residual urine volume greater than 100cc after urinating + Currently or plan to receive radiotherapy within the next six months + Received radiotherapy within the last six months + Suspected bladder cancer + Unsuccessfully treated bladder stones + A bleeding disorder It is important to talk with your physician before selecting any treatment option.





GET MORE INFORMATION.

KEY RESOURCES


Guiffart P, Reix B, Martin-Malburet A, Marcelli F, Biardeau X. Adjustable continence therapy balloons in women: Evolution of efficacy within the 24 months following implantation. Prog Urol. 2018; 28(16):927-934. doi: 10.1016/j.purol.2018.09.003. French. Freton L, Tondut L, Enderle I, Hascoet J, Manunta A, Peyronnet B. Comparison of adjustable continence therapy periurethral balloons and artificial urinary sphincter in female patients with stress urinary incontinence due to intrinsic sphincter deficiency. Int Urogynecol J. 2018; 29(7);949-957. doi: 10.1007/s00192-017-3544-8. Chevrot A, Jaffard A, Medici M, Costa P, Wagner L, Moreau-Gaudry A, Droupy S and Voros S. Rigid cystoscopy versus retrovision for adjustable peri-urethral balloons guidance: Comparision of precision thanks to a surgical navigation system. Prog Urol. 2016; 2(10):566-572. French. Billault C, Chartier-Kastler E, Roupret M, Robain G, and Phe V. Functional outcomes of adjustable continence therapy (ACT™) balloons in women aged >80 years and suffering from stress urinary incontinence caused by intrinsic sphincter deficiency. World J Urol. 2015; 33(11):1897-1903 doi:10.1007/s00345-015-1520-9.




FAQs


Is age a limiting factor for this procedure? Age is not a limiting factor. The physician will need to determine if you will qualify for the ACT. I have previously had another device implanted to treat my incontinence and it has not been successful. Am I a candidate for ACT? Slings have been successful in treating many women who are suffering from stress urinary incontinence (SUI) but many patients are looking for less invasive therapies. ACT can be a good alternative and can be implanted in patients who have previously had a sling procedure. ACT can be easily implanted, adjustable, and can be removed without a complicated surgery. ACT is a balloon, NOT a mesh device. I have tried injectables or bulking agents without success. Am I a candidate for ACT? Yes, injectables may have some short-term effect but often wear off over time and are not removable. How many women have been implanted? This therapy has been commercially available since 2002 outside the USA. To date, over 6,000 women have been implanted with ACT. What if ACT doesn’t work for me? If you see no improvement with ACT, or are not satisfied with the amount of improvement, it can be removed at any time. The balloons are deflated and removed in an office setting with no invasive surgery required. After it is removed, you can be re-implanted with ACT within 4-6 weeks or pursue other therapy options.





IMPORTANT SAFETY INFORMATION

The ACT System is indicated for the treatment of moderate to severe stress urinary incontinence in adult females with intrinsic sphincter deficiency (ISD) who have failed to respond adequately to non-surgical therapy or adult females who have failed another surgical therapy.

The potential risks with the ACT implant procedure are similar to those for other surgical treatments for stress urinary incontinence. These include but are not limited to tissue perforation, device migration, post-operative urgency, frequency or retention, tissue erosion/infection at the implant site, device failure and non-response to treatment. Women who are sexually active or have ISD due to a neurogenic cause may have worse functional results or greater incidence of complications.

If an infection occurs at the implant site, it can be treated with antibiotics. If a more serious side effect occurs (e.g., perforation, migration, erosion), ACT can be completely removed in an office setting. 

Your doctor is your best source for information on the risks and benefits of ACT. Talk to your doctor for a complete listing of risks, warnings and important safety information.

FIND A PHYSICIAN NEAR YOU

Ready to reclaim your continence, find an ACT implanter near you!

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