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New Study Confirms First Safety Outcomes for Rigicon ContiClassic®: Artificial Urinary Sphincter, in Male Stress Urinary Incontinence Treatment


We proudly announce the publication of the clinical study article „First Safety Outcomes for Rigicon ContiClassic: Artificial Urinary Sphincter.“ This study sheds light on the safety profile of the Rigicon ContiClassic in treating male stress urinary incontinence (SUI) and positions it as a comparable, innovative option alongside existing solutions.

Introduced to the international market just two years ago, the Rigicon ContiClassic Artificial Urinary Sphincter has rapidly garnered attention as a viable treatment option for men grappling with stress urinary incontinence.

The study focused on patient demographics, surgical intricacies, and underlying causes of incontinence, revealing commendable efficacy across a diverse patient cohort. Notably, participants had a mean age of 68.3 years, with post-radical prostatectomy-related urinary incontinence accounting for 58.6% of implantations. Encouragingly, the study reported no instances of infections or significant complications. A highlight of the study was the Kaplan-Meier calculation, demonstrating an impressive 93.2% survival rate at the 12-month milestone.

Renowned urology authority, Dr. Steven K. Wilson, commended the study’s findings, stating, „The Rigicon ContiClassic represents an important step in addressing male stress urinary incontinence. Its innovative design and comparable safety outcomes position it as a valuable choice for patients seeking effective solutions.“

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 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).

Most patients who experience weekly urinary incontinence do not seek care for it. Many who sought treatment believe that none was provided and many who received treatment continue to have troubling symptoms.

 

About Artificial Urinary Sphincter

Artificial Urinary Sphincter (AUS) is a medical device specifically designed to treat urinary incontinence. 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) AUS will close the urethra 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 around 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’ experience in Urology. We focus on creating a comprehensive product portfolio for urologist(s) around the world. Committed to improving the quality of life for patients, Rigicon focuses on providing cutting-edge treatments that address various urological conditions, including erectile dysfunction and urinary incontinence.


Release Date: August 23, 2023