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PROACT™

Adjustable Continence Therapy For Men

Control Starts with ProACT™,  Adjustable Continence Therapy for Men

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

ProACT Balloon

WHAT IS PROACT?

ProACT, Adjustable Continence Therapy for Men consists of two small, adjustable, silicone balloons each connected with tubing to a port. The balloons are placed where the prostate was removed or resected. The fluid-filled balloons apply pressure to and support the bladder neck, which helps prevent accidental leakage of urine. The ports are placed just below the skin in your scrotum to allow your physician to adjust the balloon to meet your individual needs.

KEY DEVICE ELEMENTS:

  • Adjustable to meet individual and changing incontinence needs.  

  • No patient manipulation required. 

  • Minimally invasive day case.

  • 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.

WHAT OUR PATIENTS HAVE TO SAY:

BOB // POST PROSTATE REMOVAL

BACKGROUND INFORMATION

“Bob had his prostate removed in April of 2011 due to prostate cancer. As a result, Bob was left with incontinence for seven years and was using 5-6 pads per day.

OUTCOME

After putting ProACT to the test, Bob now uses a light pad after the device was adjusted three times. As a result of meeting his individual continence needs, Bob has gotten his life back thanks to the ProACT therapy.

Results may vary. Not all patients respond the same. Bob received no compensation for this testimonial.

The potential risks with the ProACT implant procedure include perforation, migration, erosion, infection, and other risks. 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), ProACT can be completely removed in an office setting. See ProACT Safety Information Sheet for further safety information. Your Doctor is your best source for further information on the risks and benefits of ProACT.

FIND A PHYSICIAN NEAR YOU

Ready to reclaim your continence, find a ProACT implanter near you!

URO-GBL-20-014

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