Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in Türkiye

Objective: To analyze data from patient information forms (PIFs) submitted to the manufacturer of a new 3-piece inflatable penile prosthesis (IPP), the Rigicon Infla10® , to summarize interim outcomes of 250 implantations in a single center, which is the largest series in Türkiye. Methods: A retr...

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Main Authors: Muhammet İhsan Karaman, Rasim Güzel, Duygu Kirkik, Orhan Koca
Format: Article
Language:English
Published: AVES 2024-07-01
Series:Urology Research and Practice
Online Access:https://urologyresearchandpractice.org/en/interim-results-of-rigicon-penile-prosthesis-implantation-in-a-single-center-the-largest-series-in-turkiye-133954
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author Muhammet İhsan Karaman
Rasim Güzel
Duygu Kirkik
Orhan Koca
author_facet Muhammet İhsan Karaman
Rasim Güzel
Duygu Kirkik
Orhan Koca
author_sort Muhammet İhsan Karaman
collection DOAJ
description Objective: To analyze data from patient information forms (PIFs) submitted to the manufacturer of a new 3-piece inflatable penile prosthesis (IPP), the Rigicon Infla10® , to summarize interim outcomes of 250 implantations in a single center, which is the largest series in Türkiye. Methods: A retrospective review of PIFs from 250 patients implanted with the IPP between January 2021 and December 2023 was performed to assess patient characteristics, surgical data, device durability, patient satisfaction, and rates of reoperation for any reason. Results: The mean ± SD (range) follow-up was 21.2 ± 8.7 (6-36) months and the mean ± SD patient age was 56.2 ± 9.1 years. The average surgical time was 47 minutes. Of the total, 2.4% of devices required removal or revision. Mechanical failure of the device was reported in 3 patients (1.2%). One patient (0.4%) required revision for noise during pumping. Two patients (0.8%) requested device removal because of dissatisfaction. No infections were observed in this series. A total of 97.6% of the Rigicon Infla10® devices were free from explant or revision. The satisfaction rate based on a single question asked to the patient by the surgeon 6 months after surgery was 98.4%. Conclusion: All Rigicon Infla10® IPPs implanted in the center prior to January 2024 were included in the retrospective analysis of volunteered PIFs. Initial durability from reoperation was demonstrated to be superior compared to other contemporary devices. Additionally, high satisfaction with treatment outcomes was reported by 92.4% of patients.
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spelling doaj-art-891bedc579cb4c649cc75e41e73a80f82025-01-31T14:01:00ZengAVESUrology Research and Practice2980-14782024-07-0150423423910.5152/tud.2025.24122Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in TürkiyeMuhammet İhsan Karaman0https://orcid.org/0000-0001-5700-0835Rasim Güzel1https://orcid.org/0000-0002-1886-5235Duygu Kirkik2https://orcid.org/0000-0003-1417-6915Orhan Koca3https://orcid.org/0000-0002-6184-8801Department of Urology, Medistate Kavacık Hospital, İstanbul, TürkiyeDepartment of Urology, Medistate Kavacık Hospital, İstanbul, TürkiyeDepartment of Medical Biology, University of Health Sciences Hamidiye Faculty of Medicine, İstanbul, TürkiyeDepartment of Medical Biology, University of Health Sciences Hamidiye Faculty of Medicine, İstanbul, TürkiyeObjective: To analyze data from patient information forms (PIFs) submitted to the manufacturer of a new 3-piece inflatable penile prosthesis (IPP), the Rigicon Infla10® , to summarize interim outcomes of 250 implantations in a single center, which is the largest series in Türkiye. Methods: A retrospective review of PIFs from 250 patients implanted with the IPP between January 2021 and December 2023 was performed to assess patient characteristics, surgical data, device durability, patient satisfaction, and rates of reoperation for any reason. Results: The mean ± SD (range) follow-up was 21.2 ± 8.7 (6-36) months and the mean ± SD patient age was 56.2 ± 9.1 years. The average surgical time was 47 minutes. Of the total, 2.4% of devices required removal or revision. Mechanical failure of the device was reported in 3 patients (1.2%). One patient (0.4%) required revision for noise during pumping. Two patients (0.8%) requested device removal because of dissatisfaction. No infections were observed in this series. A total of 97.6% of the Rigicon Infla10® devices were free from explant or revision. The satisfaction rate based on a single question asked to the patient by the surgeon 6 months after surgery was 98.4%. Conclusion: All Rigicon Infla10® IPPs implanted in the center prior to January 2024 were included in the retrospective analysis of volunteered PIFs. Initial durability from reoperation was demonstrated to be superior compared to other contemporary devices. Additionally, high satisfaction with treatment outcomes was reported by 92.4% of patients.https://urologyresearchandpractice.org/en/interim-results-of-rigicon-penile-prosthesis-implantation-in-a-single-center-the-largest-series-in-turkiye-133954
spellingShingle Muhammet İhsan Karaman
Rasim Güzel
Duygu Kirkik
Orhan Koca
Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in Türkiye
Urology Research and Practice
title Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in Türkiye
title_full Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in Türkiye
title_fullStr Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in Türkiye
title_full_unstemmed Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in Türkiye
title_short Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in Türkiye
title_sort interim results of rigicon penile prosthesis implantation in a single center the largest series in turkiye
url https://urologyresearchandpractice.org/en/interim-results-of-rigicon-penile-prosthesis-implantation-in-a-single-center-the-largest-series-in-turkiye-133954
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