Im Zeitraum von 1999 bis 2009 wurde am Universitätsklinikum Göttingen bei 65 Patienten im Rahmen einer Harninkontinenztherapie ein operativer Eingriff mit einem künstlichen Sphinktersystem durchgeführt. Die vorliegende Arbeit untersucht den Erfolg dieser Behandlungsmethode. Dazu wurden sowohl präoperative Befunde aus den Patientenakten erhoben als auch der postoperative Verlauf bewertet. Mit Hilfe zweier validierter Fragebögen sowie selbst formulierter Zusatzfragen, die sich mit der allgemeinen Lebensqualität der behandelten Patienten, mit der Inkontinenzsymptomatik und der die Miktion betreffenden Lebensqualität beschäftigen, sollen sowohl die subjektive Patientenzufriedenheit als auch Veränderungen bezüglich der präoperativen und postoperativen Kontinenzsituation der Betroffenen evaluiert werden. Die Schwerpunkte der Auswertung betreffen die postoperative Kontinenzsituation, die Komplikationsrate und die Zufriedenheit der Patienten mit dem Behandlungserfolg. Die Ergebnisse werden mit bereits veröffentlichten Literaturangaben verglichen und diskutiert.

Submitted by Fabio Sobreira Campos da Costa (fabio.sobreira@ufpe.br) on 2016-09-19T13:22:14Z No. of bitstreams: 2 license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) 06.01.16 - TESE - MARCILIO (1) (1).pdf: 2477100 bytes, checksum: 4c3e51b36f4be713ec3d0a4fb02e62ca (MD5) / Made available in DSpace on 2016-09-19T13:22:14Z (GMT). No. of bitstreams: 2 license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) 06.01.16 - TESE - MARCILIO (1) (1).pdf: 2477100 bytes, checksum: 4c3e51b36f4be713ec3d0a4fb02e62ca (MD5) Previous issue date: 2016-01-22 / Introdução: A incontinência urinária agrega consequências físicas e psíquicas ao seu portador, e sua incidência tem crescido ultimamente, principalmente em decorrência da prostatectomia radical.Slings e esfíncteres artificiais são opções terapêuticas usuais no enfrentamento desse problema. O implante desses artefatos traz um alto índice de satisfação, embora se acompanhe de complicações como a atrofia e a erosão uretrais. Objetivo: Uma fita de celulose bacteriana, processado a partir da cana-de-açúcar, foi avaliado como envoltório de reforço da parede uretral, em modelo animal, com o fito de possível aplicação na prática clínica, por ocasião do emprego de dispositivos anti-incontinência urinária. Método: Neste estudo, 40 ratas Wistar, foram separadas em 4 grupos de 10. O primeiro grupo, chamado de sham, a uretra foi apenas dissecada e deixada em seu leito. O segundo grupo, teve a uretra enrolada com fita de celulose bacteriana, logo abaixo do colo vesical. O terceiro grupo, teve a uretra enrolada nessa mesma posição com fita de silicone. O quarto grupo, teve a uretra enrolada com fita de celulose bacteriana + fita de silicone(duplo implante).As fitas tinham 0,3 cm de largura, sendo que as de silicone foram ancoradas com fio inabsorvível. Metade dos animais de cada grupo foi sacrificado aos 4 meses, e a outra metade, aos 8 meses. Nos sacrifícios, a bexiga e a uretra foram retiradas em bloco, fixados em formalina e preparados em lâminas, coradas pela hematoxilina-eosina e tricrômio de Masson. O comportamento da membrana de celulose bacteriana como instrumento de reforço da parede uretral foi avaliado pela espessura, densidade de vasos sanguíneos e de colágeno(em percentual) e a reação inflamatória(pelo escore: 0=ausente; 1=leve; 2= moderada; 3= severa). Resultado: Observou-se aos 4 meses, intensa reação inflamatória, inclusive com presença de linfonodos, com diferença estatística entre o grupo da celulose bacteriana, em comparação ao grupo do silicone e grupo sham. Aos 8 meses, houve atenuação da resposta inflamatória em todos os grupos. O epitélio uretral apresentou encolhimento no grupo da celulose bacteriana e no grupo do duplo implante, em relação ao grupo do silicone, neste tempo de observação. A parede uretral, medida da lâmina própria ao limite externo da camada muscular, mostrou aos 8 meses, ganho estrutural significativo no grupo da celulose bacteriana, quando comparado aos grupos do silicone e do grupo do duplo implante(p=0,0249 e p=0,0020, respectivamente). A vasculogênese esteve mais presente no grupo da celulose bacteriana isolada, em comparação aos grupos onde se empregou o silicone. A deposição de colágeno variou de leve a moderada no grupo da celulose bacteriana, onde se notava fibras colágenas maduras, porém mostrando-se mais presente nos grupos com silicone, onde se observou formação de cápsula fibrótica aos 4 meses. Conclusão: Com base nessas observações, podemos concluir que a membrana de celulose bacteriana, integrou-se ao tecido hospedeiro, em modelo animal, com promoção de remodelação tissular e fortalecimento da arquitetura uretral. / Objective: Urinary incontinence adds physical and psychological desabilites to patients especially in the adult age.Its incidence has grown significantly, mainly due to the growing number of radical prostatectomy performed fo the treatment of prostatic cancer. Slings and artificial sphincters are usual therapeutic options to treat this condition. The implant of these devices brings a high level of satisfaction, although it is associated with complications such as atrophy and urethral erosion. A cellulose biopolymer, processed from sugarcane molasses was evaluated as a reinforcing wrap to the urethral wall, in animal models, to investigate the possible application in clinical practice, during the implantation of urinary anti-incontinence devices. Method: In this study, 40 Wistar rats were divided into 4 groups of 10. The first group, called sham, the urethra was dissected and only left his bed. Group 2 had the urethra wrapped with tape cellulosic membrane, just below the bladder neck. Group 3 had the urethrasrrounded in the same position with a silicone tape. Group 4 had the urethra wrapped with tape cellulosic membrane + silicone tape (double implants) .The strips were 0.3 cm wide, and the silicone were anchored with nonabsorbable sutures. Half of the animals in each group was sacrificed at 4 months and the other half after 8 months. During the sacrifices, the bladder and urethra were removed en bloc, fixed in formalin and prepared on slides, stained with hematoxylin-eosin and Masson trichrome. The cellulosic membrane performance was evaluated comparatively considering the thickness of the urethral wall (in percent) blood vessel density and collagen (in percent) and the inflammatory reaction (by score: 0 = absent; 1 = mild; 2 = moderate; 3 = severe). Results: It was observed at 4 months intense inflammatory reaction, even with the presence of lymph nodes, with statistical difference between group 2 compared to group 3 and group 1. At 8 months, there was attenuation of inflammatory response in all groups. The urethral epithelium showed shrinkage in group 2 and group 4 when compared to group 3, at this observation time. The urethral wall, when measured forma the lamina propria to the outer limit of the muscular layer, shown at 8 months, significant structural gain in group 2 compared to groups 3 and 4 (p = 0.0249 and p = 0.0020, respectively). Vasculogenesis was more present in the isolated biopolymer group compared to the group where silicone was used . The collagen deposition ranged from mild to moderate in group 2, being more present in groups with silicone, where it was observed formation of a fibrotic capsule at 4 months. Conclusion: Based on these observations, we conclude that the bacterial cellulose membrane was integrated to the host tissue in animal models, to promote tissue remodeling and strengthening of the urethral architecture.

Artificial urinary sphincters have been used for decades for treatment of urinary incontinence. A commonly used device, the AMS 800 consists of a urethral cuff, pump and an abdominal reservoir. Notable complications of this system include scrotal or labial hematomas, infection or erosion of the cuff and rarely migration of its components. Although there are few reported cases related to effects from pump migration, those documenting reservoir related complications are even rarer. We present a case of reservoir migration adjacent to the ascending colon causing ischemic changes mimicking colonic neoplasm. Our patient, a 66-year old male with medical history of adenocarcinoma of prostate status post radical prostatectomy, had been having abdominal pain for a month. A CT scan showed cecal and proximal ascending colonic irregular nodular thickening suggestive of colonic mass. It also revealed a low-density structure next to the ascending colon abutting into area of the mass. A follow up colonoscopy showed a fungating, ulcerated mass extending from cecum to ascending colon concerning for a malignancy of which biopsy was also done. The patient then underwent right open hemicolectomy. During surgery, a balloon reservoir was seen in the abdominal cavity with its adherence to the right colon but not eroding into it. The surgeon dissected the balloon, repositioned and re-peritonealized it before closing the abdomen. The colonoscopic and surgical pathology instead demonstrated findings of ischemic colitis with mucosal ulceration in cecum and ascending colon limited to the mucosa but no evidence of cancer. Retrospective chart review revealed history of artificial urinary sphincter implantation for urinary incontinence related to radical prostatectomy for adenocarcinoma eight years prior. With manufacturer suggested implant location of the reservoir in prevesical space, the possibility of migration needs to be accounted for. Although there are not many reports of artificial sphincter reservoir related complications, there are cases documenting inflatable penile prosthesis reservoir erosion into abdominal and pelvic structures. As the CT scan demonstrated reservoir indentation into the ascending colon, it likely led to chronic irritation of the adjacent colonic wall due to mass effect. It is hypothesized that constant pressure on colonic wall likely led to localized ischemia. This resulted in localized inflammation including submucosal edema, which can create a mass-like appearance when severe. This case emphasizes that, while preliminary radiographic imaging and even gross colonoscopy findings may be suggestive of a malignancy, it is imperative to await biopsy results to confirm the diagnosis of a malignant neoplasm. Our case report emphasizes the consideration of diagnoses other than colon cancer when faced with a colonic mass especially in the setting of implanted intra-abdominal foreign body to avoid unnecessary surgery and related complications.

La société UroMems propose de résoudre les problèmes d’incontinence urinaire avec un nouveau sphincter urinaire artificiel, dans lequel le mécanisme de pompe manuelle utilisé dans les sphincters actuellement implantés dans de nombreux patients est remplacé par un dispositif mécatronique. Une manchette occlusive, mimant le fonctionnement du sphincter naturel, est reliée et activée par le dispositif afin d’autoriser la miction et l’incontinence du patient.Le travail de thèse s’oriente sur la compréhension et l’amélioration du sphincter artificiel. La première partie de cette étude porte sur la numérisation et la modélisation 3D de cette manchette, la caractérisation mécanique de ses différents composants et la mise en place d’un modèle éléments finis. Un banc de test sur un cas simple avec suivi par stéréo-corrélation d’images est également présenté afin de valider le comportement du modèle numérique pour un chargement simple. La deuxième partie porte sur la simulation du geste chirurgical et du fonctionnement de la manchette ainsi qu’une validation du modèle éléments finis en comparaison avec des mesures effectuées sur paillasse. La troisième partie de ce travail consiste à produire des données expérimentales sur sujet anatomique afin d’observer le fonctionnement de la manchette dans son environnement naturel. Les résultats de cette étude ont motivé l’utilisation d’un matériau fantôme (un hydrogel de Polyvinyl alcohol) dont les propriétés mécaniques sont ajustables. Une caractérisation mécanique de cet hydrogel est présentée ainsi qu’un banc d’essai servant de cas test pour la validation du modèle numérique complet. La quatrième partie propose une analyse histo-morphologique de l’urètre masculin, ainsi qu’une caractérisation mécanique complète. Les données obtenues sont ensuite intégrées au modèle éléments finis afin de simuler le fonctionnement de la manchette occlusive dans son environnement naturel. Dans la dernière partie l’outil numérique mis en place est exploité afin de proposer des pistes d’améliorations du sphincter artificiel actuel. / UroMems aims at developing a novel treatment solution for severe urinary incontinence by replacing the manual pump mechanism, which is currently considered as the gold standard and which is implanted in patients throughout the world, by a mechatronic device. An occlusive cuff that mimics the natural human sphincter is linked to the device in order to ensure continence and allow micturition.This work focuses on understanding and improving the artificial sphincter. The first part of this study aims at modeling of the occlusive cuff, characterizing the mechanical behavior of all of its components and establishing a corresponding finite element model. A bench test using digital image correlation is also presented in order to validate the behavior of the numerical model for a simple test. In the second part the implantation of the occlusive and its inflation are simulated and the model is validated by comparing its results to the data measured experimentally. The third part aims at validating the interaction between the occlusive cuff and an extraneous body in the numerical simulation. To this end the in vivo experimental behavior of the occlusive cuff is observed. The variability measured among the different subjects motivated the use of a phantom material (a Polyvinyl alcohol hydrogel) of controlled mechanical properties. A thorough mechanical characterization of the hydrogel is also presented in this part as well as a test bench used for the validation of the numerical model. The fourth part proposes a histo-morphological analysis of the male urethra and its mechanical characterization. The data obtained were then integrated to the finite element model. The last part of this work is dedicated to exploiting the finite element tool to propose design improvement of the occlusive cuff.

(1) Background: This study examined outcomes of second-line ATOMS implantation after failure of the fixed male sling (FMS) AdVance/AdVance XP. (2) Methods: A retrospective multicenter cohort analysis was carried out in men implanted with an ATOMS between 2011 and 2020 after failure of an AdVance/AdVance XP. Success was assessed on the basis of objective (dryness, 0–1 pad/24 h or >20 g/24 h pad test) and subjective results (PGI-I). We performed the Wilcoxon rank sum test, Fisher’s exact test, logistic regression, and multivariate analysis. (3) Results: The study included 88 patients from 9 centers with a mean age of 71.3 years. No Clavien–Dindo > II complications occurred within the first 3 months after ATOMS implantation. A total of 10 cases (9%) required revision in the ensuing clinical course. After a mean follow-up of 42.5 months, 76.1% achieved social continence, and 56.8% used no pads at all. Mean urine leakage/24 h dropped from 422 g (3.9 pads) to 38 g (0.69 pads) and the mean ICIQ-SF decreased from 16.25 to 5.3 (p < 0.0001). PROMs (patient-reported outcome measures) showed improvement in 98.9% of cases, and 63.6% gave a “very much better” PGI-I rating. Multivariate analysis identified a lower probability of achieving maximum satisfaction for the following factors: the AdVance XP as first-line therapy (OR 0.35), a lower ICIQ-SF question 1 (OR 0.26), status post-irradiation (OR 0.14), and more severe pain prior to ATOMS implantation (OR 0.51). (4) Conclusions: Implantation of an ATOMS is an effective and safe second-line treatment option for recurrent urinary incontinence after implantation of an AdVance/AdVance XP sling. High patient satisfaction was demonstrated in a long-term follow-up.