Author: Sercan Ataikiz

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.

The clinical study, titled “Safety Outcomes of the First Rigi10 Malleable Penile Prostheses Implanted Worldwide” provides a comprehensive evaluation of the safety of the Rigi10 Malleable Penile Prosthesis.

This study underscores the device’s status as a reliable solution for patients seeking treatment for erectile dysfunction (ED). Conducted between March 2019 and December 2022, it encompassed the participation of 605 first-time patients who were implanted with the Rigi10 by 46 high-volume, experienced implanters in 15 countries.

Survival calculations were performed at 12 months, 24 months, and 36 months, yielding Kaplan-Meier statistical survival curves with survival rates of 98.8%, 98.9%, and 99.2%, respectively. The device offers an efficient solution for addressing ED while ensuring exceptional safety and patient contentment. In this study, Rigi10 MPP was successful in treating ED in 603 out of 606 patients (99.5%). The paucity of revision operations was remarkable.

Compared to its competitors, notable features of Rigi10 include the supple bending capacity of its rods, simplifying implantation through a smaller corporotomy, and the availability of extra widths of rods that facilitate precise penile girth attainment. Support for this is evident in the study, which indicates that the 12 mm cylinder size, not offered by competitive devices, was the second most used cylinder width.

Rigi10’s safety was convincingly demonstrated; according to the results, Rigi10 MPP had no mechanical malfunctions, and the risk of prosthesis erosion (0.17%), infection (0.33%), or patient dissatisfaction (0.49%) was quite low. Less than 1% of all implants required reoperation for any reason.

The Rigi10 MPP, introduced in 2019, is a sterile, trimmable, and single-use implant that consists of two rods available in two lengths and six different widths, along with extender tips. The rods have stainless-steel wires, which are quite flexible, improving concealability under the patient’s clothing. The Rigi10 provides the required rigidity, comfort, and discretion to patients with ED.

Rigicon remains dedicated to advancing the field of prosthetic urology and providing patients with a safe and effective option for addressing ED. This study underscores Rigicon’s unwavering commitment to these goals.

About Erectile Dysfunction

Erectile Dysfunction, or ED, is the inability to achieve or sustain an erection suitable for sexual intercourse. ED is a common sexual disorder and may have a permanent course, as some cannot have any erection for the remaining part of their lives. ED might have a profound impact on the quality of life and social relationships of the patient.

ED may be caused by various diseases and disorders, including heart disease, diabetes, pelvic area damage due to surgery, accidents, or radiation therapy, benign prostatic hyperplasia (BPH, a non-cancerous enlargement of the prostate tissue), disorders associated with low testosterone levels, Parkinson’s disease, and other neurological diseases. 

About Malleable Penile Prosthesis

A malleable penile prosthesis is a medical device that allows an impotent patient to achieve an erection. The malleable implant consists of two rods that are always hard but pliable. All components are concealed within the body and cannot be seen from the outside. The penile implant rods reside in the penis on either side. No tissue is removed to place the rods; the rods simply occupy spaces previously filled with blood when one was potent. The rods do not disrupt the flow of urine or ejaculate, and they do not alter the sensation of the penis. 

About Rigicon

Rigicon specializes in the research, development, and manufacturing of innovative prosthetic urology solutions, with 30 years of experience in urology. We focus on creating a comprehensive product portfolio for urologists 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.

A recent clinical study article published titled “Survival From Revision Surgery for New Rigicon Infla10 Three-piece Inflatable Penile Prosthesis Is Comparable to Preceding Devices.” This study highlights the safety and performance of the Rigicon Infla10 Inflatable Penile Prosthesis, showcasing its potential as an effective solution in prosthetic urology.

In its initial 2 to 3 years of availability, the Rigicon Infla10 Inflatable Penile Prosthesis has shown notable resilience against the need for revision, similar to well-established already in-market devices. Analyzing data from the first 535 patients who received the Rigicon Infla10 (between January 2019 and August 2022), the study emphasizes its safety record, mechanical stability, infection incidence, and patient satisfaction in comparison with other devices.

Key findings echo the preliminary research, underlining the Infla10’s impressive durability. Mechanical Stability: The Rigicon Infla10’s mechanical failure rate is comparable to other available devices, signifying its long-term effectiveness.

Another key finding showed that Rigicon Infla10’s infection rate is found to be very low, with only a single instance among the 535 patients under observation. The infection rate of the Infla10 three-piece IPP with 103 different implanting surgeons is well within expectations.

Renowned urologist Dr. Steven K. Wilson, a contributor to the study, notes, “The Rigicon Infla10 marks progress in prosthetic urology. The data reaffirms the company’s commitment to innovative prosthetic urology solutions, providing reliable options that make a positive impact on patients’ lives.”

About Erectile Dysfunction

Erectile Dysfunction, or ED, is the inability to achieve or sustain an erection suitable for sexual intercourse. ED is a common male sexual disorder and may maintain a permanent course as some men cannot have any erection for the remaining part of their life. ED might have a deep impact on the quality of life and social relationships of the patient.

ED may be basically caused by various diseases and disorders including heart disease, diabetes, pelvic area damage due to surgery, accidents or radiation therapy, benign prostatic hyperplasia (BPH, which is non-cancerous enlargement of the prostate tissue), disorders associated with low testosterone levels, Parkinson’s disease, and other neurologic diseases.

About Inflatable Penile Prosthesis

About Inflatable Penile Prosthesis (Three–Piece Inflatable Penile Prosthesis)

Inflatable devices, the most common type of penile implant used, can be inflated to create an erection, and deflated at other times. Three-piece inflatable implants use a fluid-filled reservoir implanted under the abdominal wall, a pump and a release valve placed inside the scrotum, and two inflatable cylinders inside the penis. (Source: Mayo Clinic)

Penile implant surgery is considered a gold standard therapy for men with erectile dysfunction.

About Rigicon

Rigicon specializes in the research, development, and manufacturing of innovative prosthetic urology solutions with 30 years’ of 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.

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.