Yeni ContiReflex Yapay Üriner Sfinkterin Güvenliği Onaylandı
Haber Özeti
Rigicon, ContiReflex® yapay üriner sfinkterin ilk güvenlik sonuçlarını açıkladı. 2022-2023 arasında radikal prostatektomi geçirmiş 50 hastada yapılan çalışmada, cihazın yüksek güvenlik ve operasyonel güvenilirlik sunduğu gözlemlendi. ContiReflex®, %98 hayatta kalma oranı ve minimal cerrahi revizyon gereksinimi ile dikkat çekti. Cihazın, intra-abdominal basınç değişikliklerine uyum sağlayarak daha tutarlı kuruluk sağladığı belirtildi. Veriler, 2024 Amerikan Üroloji Derneği Yıllık Toplantısı’nda sunuldu.
New Study Confirms First Safety Outcomes of ContiReflex® Artificial Urinary Sphincter for Treating Male Incontinence
Rigicon proudly announces the publication of the clinical study article titled “First Safety Outcomes of ContiReflex® Artificial Urinary Sphincter for Treating Male Incontinence”.
ContiReflex® has been shown to offer comparable safety outcomes to other devices on the market.
Spanning from April 2022 to October 2023, the study involved the first 50 patients who received the ContiReflex® device. Most patients had undergone radical prostatectomy, with ages ranging from 57 to 84 years.
ContiReflex® showcased a high level of safety and operational reliability, evidenced by a 98% survival rate at 18 months post-implantation. Notably, the device required minimal surgical revisions, emphasizing its precision and effectiveness in clinical application.
Data on the “Early Safety Outcomes of the ContiReflex® Artificial Urinary Sphincter for Treating Male Incontinence” were presented at the 2024 American Urological Association Annual Meeting in San Antonio, Texas, USA.
ContiReflex® Enhanced Artificial Urinary Sphincter (AUS), a novel device developed by Rigicon, is being used to treat urinary incontinence due to intrinsic sphincter deficiency in cases such as incontinence following prostate surgery.
Unlike traditional devices, the ContiReflex® with its smart reflex balloon constantly senses intra-abdominal pressure changes and simultaneously adapts the pressure on the urethra, potentially helping patients stay dry more consistently.
The ContiReflex’s unique two-component design allows the system to adjust cuff pressure in real time, based on intra-abdominal pressure changes. This means that it can potentially achieve satisfactory continence outcomes with a lower baseline pressure than traditional devices.
New cuff sizes provide surgeons with a range of occlusive cuff options, which are available in incremental sizes of 0.25 cm, ranging from 3.5 to 5 cm, for a personalized fit to the patient’s urethral anatomy.
Unlike other devices on the market, ContiReflex® is uniquely manufactured with a HydroShield™ hydrophilic coating on all external surfaces, including the pressure-regulating balloon. The HydroShield™ coating allows for diverse dipping options, enabling a customized approach to meet the specific needs of the surgeon and the patient.
About Urinary Incontinence
Urinary incontinence (UI) is the involuntary loss of urine. Patients suffering from urinary incontinence are unable to control the release of urine from the bladder. While Stress Urinary Incontinence (SUI) is the most common type, there are different types of urinary incontinence. Stress urinary incontinence is the unexpected leakage of urine when an outside pressure occurs with activities such as heavy lifting, coughing, sneezing, laughing, or exercise. This outside pressure causes the already weakened bladder to leak urine.
Weakened urinary sphincters may be caused by: Surgery in the pelvic area or the prostate, injury to the urethra, medicines, being overweight, changes with age, and other causes. Urinary incontinence is a significant problem, affecting tens of millions of patients. UI is estimated to affect 1 out of 10 males, with increasing prevalence associated with aging.
Men with urinary incontinence have a higher rate of depression and are more likely to decrease participation in activities (e.g., decrease work hours, change employment, or take voluntary early retirement).
About Artificial Urinary Sphincter
Artificial Urinary Sphincter (AUS) is a medical device specifically designed to treat urinary incontinence. An Artificial Urinary Sphincter is a surgical treatment option when non-surgical or behavioral treatment options fail.
AUS will mimic the role of a healthy urinary sphincter (the two muscles controlling the exit of urine from the bladder through the urethra) closing the urethra, and preventing urine leakage. The patient will squeeze a pump located in his scrotum to release the cuff over the urethra and void. The cuff will return to its closed state in about 2 minutes to prevent urine leakage after voiding.
The artificial urinary sphincter is widely regarded as the gold standard for the treatment of urinary incontinence.
About Rigicon
Rigicon specializes in the research, development, and manufacturing of innovative prosthetic urology solutions, with 30 years of experience in urology. Rigicon continues to introduce cutting-edge technologies that improve patient outcomes and enhance the quality of life for those suffering from urinary conditions, including erectile dysfunction and urinary incontinence. Rigicon’s commitment to innovation and patient care continues to redefine industry standards and improve the quality of life for patients globally.