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Clinical Evidence

Clinical Evidence

Peer-reviewed publications and clinical evidence from the frontiers of prosthetic urology
Clinical Evidence
Clinical Evidence
Peer-reviewed publications and clinical evidence from the frontiers of prosthetic urology
  • Featured Papers

    Celebrating 50 Years of Penile Implants

    This perspective article reviews the 50-year evolution of penile implants, covering historical milestones, technical improvements, and the emergence of Rigicon Infla10®.

    IJIR: Your Sexual Medicine Journal 2023
    Infla10® Pulse IPP Series
    Read Paper

    The International Penile Prosthesis Implant Consensus Forum: clinical recommendations and surgical principles on the inflatable 3-piece penile prosthesis implant

    A global panel of prosthetic urologists provides surgical guidelines for 3-piece inflatable penile prostheses. Recommendations emphasize patient selection, surgical safety, and postoperative care, featuring Rigicon's Infla10®.

    Nature Reviews Urology 2022
    Infla10® Pulse IPP Series
    Read Paper

    New Advancements in Inflatable Penile Prosthesis

    This review evaluates the latest design and functional updates in inflatable penile prostheses (IPPs), covering pumps, cylinders, reservoirs, anti-infective coatings, and transgender-specific devices. It emphasizes clinical innovations with relevance to Rigicon’s IPP system.

    Sexual Medicine Reviews 2020
    Infla10® Pulse IPP Series
    Read Paper
    Clinical Outcome Studies

    Sliding Technique Through a Non-Degloving Approach for Peyronie’s Disease: 2-Surgeon Experience

    This retrospective study describes a novel non-degloving sliding technique (ST) for penile length restoration in Peyronie’s Disease with erectile dysfunction. The method demonstrated effective curvature correction and length gain with minimal complications. Relevant for Rigi10™.

    The Journal of Sexual Medicine 2022
    Rigi10 Malleable Penile Prosthesis
    Read Paper

    Modified malleable prosthesis with a fixed mesh: case series for the Ghattas technique

    This study introduces the Ghattas technique—using a polypropylene mesh fixed around a 13-mm malleable prosthesis—to increase the prosthesis diameter for patients with large corporal bodies. The method led to significantly improved IIEF-5 and EDITS scores. The Rigicon malleable prosthesis was used in select cases.

    Asian Journal of Andrology 2022
    Rigi10 Malleable Penile Prosthesis
    Read Paper
    Peer-Reviewed Publications

    Celebrating 50 Years of Penile Implants

    This perspective article reviews the 50-year evolution of penile implants, covering historical milestones, technical improvements, and the emergence of Rigicon Infla10®.

    IJIR: Your Sexual Medicine Journal 2023
    Infla10® Pulse IPP Series
    Read Paper

    Initial Safety Outcomes for Rigicon Infla10® Inflatable Penile Prosthesis

    This multicenter retrospective study evaluated early safety outcomes of the Rigicon Infla10® IPP in 319 patients. At 21 months, 95.6% of devices remained free from revision or removal. The device showed low rates of mechanical failure and no infections.

    BJU International 2023
    Infla10® Pulse IPP Series
    Read Paper

    The International Penile Prosthesis Implant Consensus Forum: clinical recommendations and surgical principles on the inflatable 3-piece penile prosthesis implant

    A global panel of prosthetic urologists provides surgical guidelines for 3-piece inflatable penile prostheses. Recommendations emphasize patient selection, surgical safety, and postoperative care, featuring Rigicon's Infla10®.

    Nature Reviews Urology 2022
    Infla10® Pulse IPP Series
    Read Paper

    The modern testicular prosthesis: patient selection and counseling, surgical technique, and outcomes

    This review outlines patient selection, counseling, and surgical techniques for testicular prostheses, highlighting high satisfaction, low complications, and the importance of counseling. Relevant to Testi10®.

    Asian Journal of Andrology 2020
    Testi10 Testicular Prosthesis
    Read Paper

    Future considerations in prosthetic urology

    This review outlines expected advancements in penile, urinary, and testicular prostheses over the next 5–10 years. It highlights device innovations like automatic pumps and neophallus-specific designs, and surgical trends such as outpatient care and non-narcotic pain protocols. Rigicon's Testi10® is mentioned among current testicular prosthetic options.

    Asian Journal of Andrology 2020
    Testi10 Testicular Prosthesis
    Read Paper

    Is there still a place for malleable penile implants in the United States? Wilson’s Workshop

    This review discusses the continued role of malleable penile prostheses (MPP) in the U.S., highlighting patient groups who benefit from them. The study compares MPP with IPP and includes Rigicon’s Rigi10® among modern MPP options.

    IJIR: Your Sexual Medicine Journal 2020
    Rigi10 Malleable Penile Prosthesis
    Read Paper

    IPP Improvements—Recent Innovations, Current Iterations, and Developments in the Pipeline

    This article highlights recent innovations and future developments in inflatable penile prostheses (IPPs), including Rigicon’s Infla10®, and compares current device offerings globally.

    The Journal of Sexual Medicine 2022
    Infla10® Pulse IPP Series
    Read Paper

    Shaeer’s Punch Technique: Trans-Corporeal Peyronie’s Plaque Surgery and Penile Prosthesis Implantation

    Shaeer’s Punch Technique enables minimally invasive removal of Peyronie’s plaques during penile prosthesis implantation. Compared to traditional methods, it shortens surgery time and reduces complications. Study includes Rigicon penile implants.

    The Journal of Sexual Medicine 2022
    Infla10® Pulse IPP Series
    Read Paper

    New Advancements in Inflatable Penile Prosthesis

    This review evaluates the latest design and functional updates in inflatable penile prostheses (IPPs), covering pumps, cylinders, reservoirs, anti-infective coatings, and transgender-specific devices. It emphasizes clinical innovations with relevance to Rigicon’s IPP system.

    Sexual Medicine Reviews 2020
    Infla10® Pulse IPP Series
    Read Paper

    Technological Advances in Penile Implant Surgery

    This review highlights the evolution of penile implant surgery, summarizing key technological milestones in materials, design, coatings, and surgical techniques. It covers malleable, 2-piece, and 3-piece inflatable devices, with emphasis on innovations that improve reliability, patient satisfaction, and surgical safety. Rigicon’s Rigi10 is included among recent FDA-approved devices with specific design enhancements. The article concludes by examining emerging trends like remote-controlled and transgender-specific implants.

    The Journal of Sexual Medicine 2021
    Rigi10 Malleable Penile Prosthesis
    Read Paper

    Penile implant infection prevention part II: device coatings have changed the game

    This review explores how antibiotic and hydrophilic coatings have drastically reduced penile implant infection rates. The authors analyze infection mechanisms and advances in prevention and salvage. Rigicon’s hydrophilic-coated IPP and malleable prostheses are positioned within this innovation shift.

    IJIR: Your Sexual Medicine Journal 2021
    Infla10® Pulse IPP Series Rigi10 Malleable Penile Prosthesis
    Read Paper

    IPP Improvements-Recent Innovations, Current Iterations, and Developments in the Pipeline

    This study reviews advancements in inflatable penile prosthesis technology, highlighting innovations like Rigicon’s Infla10 system aimed at improving functionality and durability.

    The Journal of Sexual Medicine 2022
    Infla10® Pulse IPP Series
    Read Paper

    A novel corporal dilation tool in penile implant surgery

    This study introduces a new corporal dilation tool for penile implant surgery, evaluating its effectiveness and safety; the Rigicon HL Dilator was highlighted.

    Northern Clinics of Istanbul 2022
    HL Dilator
    Read Paper

    The Rigicon Infla10® IPP implantation via the penoscrotal and subcoronal approaches: The UKSH experience

    Clinical outcomes of Rigicon Infla10® IPP implantation via penoscrotal and subcoronal approaches at UKSH, highlighting surgical success, patient safety, and satisfaction.

    The Journal of Sexual Medicine 2022
    Infla10® Pulse IPP Series
    Read Paper
  • Clinical Outcome Studies

    Sliding Technique Through a Non-Degloving Approach for Peyronie’s Disease: 2-Surgeon Experience

    This retrospective study describes a novel non-degloving sliding technique (ST) for penile length restoration in Peyronie’s Disease with erectile dysfunction. The method demonstrated effective curvature correction and length gain with minimal complications. Relevant for Rigi10™.

    The Journal of Sexual Medicine 2022
    Rigi10 Malleable Penile Prosthesis
    Read Paper

    Modified malleable prosthesis with a fixed mesh: case series for the Ghattas technique

    This study introduces the Ghattas technique—using a polypropylene mesh fixed around a 13-mm malleable prosthesis—to increase the prosthesis diameter for patients with large corporal bodies. The method led to significantly improved IIEF-5 and EDITS scores. The Rigicon malleable prosthesis was used in select cases.

    Asian Journal of Andrology 2022
    Rigi10 Malleable Penile Prosthesis
    Read Paper
  • Peer-Reviewed Publications

    Celebrating 50 Years of Penile Implants

    This perspective article reviews the 50-year evolution of penile implants, covering historical milestones, technical improvements, and the emergence of Rigicon Infla10®.

    IJIR: Your Sexual Medicine Journal 2023
    Infla10® Pulse IPP Series
    Read Paper

    Initial Safety Outcomes for Rigicon Infla10® Inflatable Penile Prosthesis

    This multicenter retrospective study evaluated early safety outcomes of the Rigicon Infla10® IPP in 319 patients. At 21 months, 95.6% of devices remained free from revision or removal. The device showed low rates of mechanical failure and no infections.

    BJU International 2023
    Infla10® Pulse IPP Series
    Read Paper

    The International Penile Prosthesis Implant Consensus Forum: clinical recommendations and surgical principles on the inflatable 3-piece penile prosthesis implant

    A global panel of prosthetic urologists provides surgical guidelines for 3-piece inflatable penile prostheses. Recommendations emphasize patient selection, surgical safety, and postoperative care, featuring Rigicon's Infla10®.

    Nature Reviews Urology 2022
    Infla10® Pulse IPP Series
    Read Paper

    The modern testicular prosthesis: patient selection and counseling, surgical technique, and outcomes

    This review outlines patient selection, counseling, and surgical techniques for testicular prostheses, highlighting high satisfaction, low complications, and the importance of counseling. Relevant to Testi10®.

    Asian Journal of Andrology 2020
    Testi10 Testicular Prosthesis
    Read Paper

    Future considerations in prosthetic urology

    This review outlines expected advancements in penile, urinary, and testicular prostheses over the next 5–10 years. It highlights device innovations like automatic pumps and neophallus-specific designs, and surgical trends such as outpatient care and non-narcotic pain protocols. Rigicon's Testi10® is mentioned among current testicular prosthetic options.

    Asian Journal of Andrology 2020
    Testi10 Testicular Prosthesis
    Read Paper

    Is there still a place for malleable penile implants in the United States? Wilson’s Workshop

    This review discusses the continued role of malleable penile prostheses (MPP) in the U.S., highlighting patient groups who benefit from them. The study compares MPP with IPP and includes Rigicon’s Rigi10® among modern MPP options.

    IJIR: Your Sexual Medicine Journal 2020
    Rigi10 Malleable Penile Prosthesis
    Read Paper

    IPP Improvements—Recent Innovations, Current Iterations, and Developments in the Pipeline

    This article highlights recent innovations and future developments in inflatable penile prostheses (IPPs), including Rigicon’s Infla10®, and compares current device offerings globally.

    The Journal of Sexual Medicine 2022
    Infla10® Pulse IPP Series
    Read Paper

    Shaeer’s Punch Technique: Trans-Corporeal Peyronie’s Plaque Surgery and Penile Prosthesis Implantation

    Shaeer’s Punch Technique enables minimally invasive removal of Peyronie’s plaques during penile prosthesis implantation. Compared to traditional methods, it shortens surgery time and reduces complications. Study includes Rigicon penile implants.

    The Journal of Sexual Medicine 2022
    Infla10® Pulse IPP Series
    Read Paper

    New Advancements in Inflatable Penile Prosthesis

    This review evaluates the latest design and functional updates in inflatable penile prostheses (IPPs), covering pumps, cylinders, reservoirs, anti-infective coatings, and transgender-specific devices. It emphasizes clinical innovations with relevance to Rigicon’s IPP system.

    Sexual Medicine Reviews 2020
    Infla10® Pulse IPP Series
    Read Paper

    Technological Advances in Penile Implant Surgery

    This review highlights the evolution of penile implant surgery, summarizing key technological milestones in materials, design, coatings, and surgical techniques. It covers malleable, 2-piece, and 3-piece inflatable devices, with emphasis on innovations that improve reliability, patient satisfaction, and surgical safety. Rigicon’s Rigi10 is included among recent FDA-approved devices with specific design enhancements. The article concludes by examining emerging trends like remote-controlled and transgender-specific implants.

    The Journal of Sexual Medicine 2021
    Rigi10 Malleable Penile Prosthesis
    Read Paper

    Penile implant infection prevention part II: device coatings have changed the game

    This review explores how antibiotic and hydrophilic coatings have drastically reduced penile implant infection rates. The authors analyze infection mechanisms and advances in prevention and salvage. Rigicon’s hydrophilic-coated IPP and malleable prostheses are positioned within this innovation shift.

    IJIR: Your Sexual Medicine Journal 2021
    Infla10® Pulse IPP Series Rigi10 Malleable Penile Prosthesis
    Read Paper

    IPP Improvements-Recent Innovations, Current Iterations, and Developments in the Pipeline

    This study reviews advancements in inflatable penile prosthesis technology, highlighting innovations like Rigicon’s Infla10 system aimed at improving functionality and durability.

    The Journal of Sexual Medicine 2022
    Infla10® Pulse IPP Series
    Read Paper

    A novel corporal dilation tool in penile implant surgery

    This study introduces a new corporal dilation tool for penile implant surgery, evaluating its effectiveness and safety; the Rigicon HL Dilator was highlighted.

    Northern Clinics of Istanbul 2022
    HL Dilator
    Read Paper

    The Rigicon Infla10® IPP implantation via the penoscrotal and subcoronal approaches: The UKSH experience

    Clinical outcomes of Rigicon Infla10® IPP implantation via penoscrotal and subcoronal approaches at UKSH, highlighting surgical success, patient safety, and satisfaction.

    The Journal of Sexual Medicine 2022
    Infla10® Pulse IPP Series
    Read Paper

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