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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. 

  • KEY RESOURCES
    Klock J, Palacios A, Leslie S, Feloney M. Artificial Urinary Sphincters and Adjustable Dual- Balloon Continence Therapy in Men. [Updated 2023 Nov 2]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. https://www.ncbi.nlm.nih.gov/books/NBK597382/ Kong L, Coddington N, Flynn B. Secondary placement of adjustable continence therapy (ProACT™) using open perineal technique: Case report of ProACT placement in a man with a devastated urethra following pelvic trauma and multiple AUS erosion. Urology Case Reports 49 (2023) 102424. https://doi.org/10.1016/j.eucr.2023.102424 Tricard T, Qi-Xiang S, et. al. Adjustable Continence Therapy (ProACT) for treatment of male SUI PP -Systematic review and meta-analysis (2023 Update). World J Urol 41, 1793–1802 (2023). https://doi.org/10.1007/s00345-023-04452-6 Ricard H, Léon G, Branchereau J, et al. Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications. Neurourol Urodyn. 2022;1‐9. doi:10.1002/nau.24967 Bada M, Crocetto F, Barone B, et al. ProACT in the management of stress urinary incontinence after radical prostatectomy. What happens after 8 years of follow up? Monocentric analysis in 42 patients. J Basic Clin Physiol Pharmacol 2022; https://doi.org/10.1515/jbcpp-2021- 0295 M. Ruggiero, U. Pinar, M.-B. Popelin et al., Single centre experience and long-term outcomes of implantable devices ACT and Pro-ACT (Uromedica, Irvin, CA, USA) Adjustable continence Therapy for treatment of stress urinary incontinence. Prog Urol, https://doi.org/10.1016/j.purol.2022.12.004 Munier P, Nicolas M, Tricard T, et al. What if artificial urinary sphincter is not possible? Feasibility and effectiveness of ProACT for patients with persistent stress urinary incontinence after radical prostatectomy treated by sling. Neurourol Urodyn. 06 April 2020:1-6. doi:10.1002/nau.24355 Noordhoff TC, Finazzi-Agrò E, Scheepe JR, Blok BFM. Outcome and complications of adjustable continence therapy (ProACTTM) in the treatment of urinary incontinence after transurethral resection of the prostate: A multicenter study. Neurourol Urodyn. 2019 Apr;38(4):1111-1119. doi: 10.1002/nau.23966. Larson T, Jhaveri H, Yeung LL. Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and metaanalysis. Neurourology and Urodynamics. 2019; 38(8):2051-2059. doi: 10.1002/nau.2413. Finazzi Agrò E, Gregori A, Bianchi D, et al. Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long‐term follow‐up data of a national multicentric retrospective study. Neurourol Urodyn. 2019 Sep;38(7):1979-1984. doi: 10.1002/nau.24103. Nash S, Aboseif S, Gilling P, Gretzer M, Samowitz H, Rose M, Slutsky J, Siegel S, Tu LM. Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™. Neurourol Urodyn. 2019; 38(1): 248-253. doi: 10.1002/nau.23838.
  • FAQs
    I am incontinent after prostate surgery. How long should I wait to consider ProACT: Most urologists suggest doing pelvic floor exercises for at least 12 months. If after this period there is no improvement, you may want to consult a urologist regarding your treatment options. What is the Difference between a male sling and ProACT? A male sling is a long strip of woven polypropylene mesh that is used to compress or reposition the urethra. Mesh devices require an invasive surgery for placement and may require extensive surgery to remove. The ProACT device consists of two small balloons made of silicone, not polypropylene mesh, which are attached by tubing to a filling port placed under the skin of the scrotum. ProACT can be simply adjusted to better fit the patient’s individual needs in the doctor’s office and does not require additional surgery. What is the difference between an artificial urinary sphincter (AUS) and ProACT? The artificial urinary sphincter is a device consisting of three main components: the cuff to constrict the urethra, the pressure regulation balloon, and the pump with tubing connecting these components. The implant procedure for an AUS is more complex and invasive than the insertion of ProACT. The AUS cannot be adjusted post-operatively to the needs of the individual patient and removal of this device requires an extensive surgery. In addition, patients with an AUS must manipulate a pump located in the scrotum every time they need to void. ProACT can be adjusted to the needs of the individual patient. The physician injects fluid into the port of the balloon in a brief office adjustment. With ProACT, the patient urinates naturally. No patient manipulation is required. How many men have been implanted with ProACT? This therapy had been commercially available since 2002 outside the USA and has been available within the USA since 2015. To date, over 10,000 men have been implanted with ProACT. What should I expect after ProACT implantation? After your ProACT surgery, your doctor will adjust your device in brief office visits to better suit your individual needs. These adjustments are intended to improve your continence. You may see an improvement right away, although it could take six months or longer to reach maximum effectiveness. What if ProACT doesn’t work for me? If you see no improvement with ProACT, 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 ProACT or pursue other therapy options.

GET MORE INFORMATION.

  • KEY RESOURCES
    Klock J, Palacios A, Leslie S, Feloney M. Artificial Urinary Sphincters and Adjustable Dual- Balloon Continence Therapy in Men. [Updated 2023 Nov 2]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. https://www.ncbi.nlm.nih.gov/books/NBK597382/ Kong L, Coddington N, Flynn B. Secondary placement of adjustable continence therapy (ProACT™) using open perineal technique: Case report of ProACT placement in a man with a devastated urethra following pelvic trauma and multiple AUS erosion. Urology Case Reports 49 (2023) 102424. https://doi.org/10.1016/j.eucr.2023.102424 Tricard T, Qi-Xiang S, et. al. Adjustable Continence Therapy (ProACT) for treatment of male SUI PP -Systematic review and meta-analysis (2023 Update). World J Urol 41, 1793–1802 (2023). https://doi.org/10.1007/s00345-023-04452-6 Ricard H, Léon G, Branchereau J, et al. Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications. Neurourol Urodyn. 2022;1‐9. doi:10.1002/nau.24967 Bada M, Crocetto F, Barone B, et al. ProACT in the management of stress urinary incontinence after radical prostatectomy. What happens after 8 years of follow up? Monocentric analysis in 42 patients. J Basic Clin Physiol Pharmacol 2022; https://doi.org/10.1515/jbcpp-2021- 0295 M. Ruggiero, U. Pinar, M.-B. Popelin et al., Single centre experience and long-term outcomes of implantable devices ACT and Pro-ACT (Uromedica, Irvin, CA, USA) Adjustable continence Therapy for treatment of stress urinary incontinence. Prog Urol, https://doi.org/10.1016/j.purol.2022.12.004 Munier P, Nicolas M, Tricard T, et al. What if artificial urinary sphincter is not possible? Feasibility and effectiveness of ProACT for patients with persistent stress urinary incontinence after radical prostatectomy treated by sling. Neurourol Urodyn. 06 April 2020:1-6. doi:10.1002/nau.24355 Noordhoff TC, Finazzi-Agrò E, Scheepe JR, Blok BFM. Outcome and complications of adjustable continence therapy (ProACTTM) in the treatment of urinary incontinence after transurethral resection of the prostate: A multicenter study. Neurourol Urodyn. 2019 Apr;38(4):1111-1119. doi: 10.1002/nau.23966. Larson T, Jhaveri H, Yeung LL. Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and metaanalysis. Neurourology and Urodynamics. 2019; 38(8):2051-2059. doi: 10.1002/nau.2413. Finazzi Agrò E, Gregori A, Bianchi D, et al. Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long‐term follow‐up data of a national multicentric retrospective study. Neurourol Urodyn. 2019 Sep;38(7):1979-1984. doi: 10.1002/nau.24103. Nash S, Aboseif S, Gilling P, Gretzer M, Samowitz H, Rose M, Slutsky J, Siegel S, Tu LM. Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™. Neurourol Urodyn. 2019; 38(1): 248-253. doi: 10.1002/nau.23838.
  • FAQs
    I am incontinent after prostate surgery. How long should I wait to consider ProACT: Most urologists suggest doing pelvic floor exercises for at least 12 months. If after this period there is no improvement, you may want to consult a urologist regarding your treatment options. What is the Difference between a male sling and ProACT? A male sling is a long strip of woven polypropylene mesh that is used to compress or reposition the urethra. Mesh devices require an invasive surgery for placement and may require extensive surgery to remove. The ProACT device consists of two small balloons made of silicone, not polypropylene mesh, which are attached by tubing to a filling port placed under the skin of the scrotum. ProACT can be simply adjusted to better fit the patient’s individual needs in the doctor’s office and does not require additional surgery. What is the difference between an artificial urinary sphincter (AUS) and ProACT? The artificial urinary sphincter is a device consisting of three main components: the cuff to constrict the urethra, the pressure regulation balloon, and the pump with tubing connecting these components. The implant procedure for an AUS is more complex and invasive than the insertion of ProACT. The AUS cannot be adjusted post-operatively to the needs of the individual patient and removal of this device requires an extensive surgery. In addition, patients with an AUS must manipulate a pump located in the scrotum every time they need to void. ProACT can be adjusted to the needs of the individual patient. The physician injects fluid into the port of the balloon in a brief office adjustment. With ProACT, the patient urinates naturally. No patient manipulation is required. How many men have been implanted with ProACT? This therapy had been commercially available since 2002 outside the USA and has been available within the USA since 2015. To date, over 10,000 men have been implanted with ProACT. What should I expect after ProACT implantation? After your ProACT surgery, your doctor will adjust your device in brief office visits to better suit your individual needs. These adjustments are intended to improve your continence. You may see an improvement right away, although it could take six months or longer to reach maximum effectiveness. What if ProACT doesn’t work for me? If you see no improvement with ProACT, 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 ProACT 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!

ACT-INTL-20-002

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