Clinical evaluation of a newly developed catheter (SpeediCath Compact Male) in men with spinal cord injury: residual urine and user evaluation.

OBJECTIVE: To evaluate the performance of a new 30-cm-long, telescoping male intermittent catheter (SpeediCath Compact Male; Coloplast A/S, Humlebæk, Denmark) in urinary bladder emptying, safety and subject acceptance vs a standard-length male intermittent catheter (SpeediCath). MATERIALS AND METHODS: In a prospective, randomized, multicenter, crossover non-inferiority study, 37 male intermittent catheter users self-catheterized three times with the test catheter on one test day and three times with the standard-length male (reference) catheter on another test day. Residual urine (RU) volume in the bladder after catheterization was measured by ultrasound. Safety was assessed in the entire study period in terms of adverse events (AEs) and adverse device events (ADEs). Subjects evaluated their experience, sensation, disposal, bleeding and discomfort with the test and reference catheters and final catheter preference. RESULTS: SpeediCath Compact Male did not differ from the reference catheter in terms of performance (bladder emptying). The upper confidence limit of the mean difference between absolute RU volumes for the test and reference catheter groups did not exceed a pre-established non-inferiority limit of 20 ml, thereby showing the test catheter's non-inferiority to the reference catheter (that is, no worse at bladder emptying). The only AE/ADE reported was one instance of mild urethral burning for 30 min after catheterization, which was judged possibly related to the test catheter but resolved quickly. CONCLUSIONS: The SpeediCath Compact Male catheter is as efficient as a conventional intermittent catheter (SpeediCath) at emptying the bladder with the additional benefit of being more discreet and easier to use.

[Urinary bladder cancer as a late sequela of spinal cord injury : Decision-making aids for assessment of this causal association]. / Harnblasenkarzinom als Spätfolge einer Querschnittlähmung : Entscheidungshilfe für eine Zusammenhangsbegutachtung.

BACKGROUND: There is to date no convincing literature that has assessed the association between traumatic spinal cord injury (SCI) and the later development of urinary bladder cancer. The aim of this work is to present medical experts as well as the national accident insurance and the social courts decision-making aids based on the latest medical scientific knowledge, for assessment of this causal association. MATERIALS AND METHODS: A study conducted between April 1998 and March 2017 in the BG Trauma Hospital Hamburg forms the basis for the decision-making aids. Urinary bladder cancer was diagnosed in 32 out of 6432 treated outpatient and inpatient SCI patients. Furthermore, relevant published literature was taken into consideration for the decision-making aids. RESULTS: It was found that urinary bladder cancer in SCI patients occurs at a considerably younger age as compared to the general population, more frequently shows muscle invasive carcinoma with a higher grade at first diagnosis and a higher proportion of the more aggressive squamous cell carcinoma than that of the general population. Correspondingly, the survival time is extremely unfavorable. For medical experts a matrix was compiled where the various influencing factors, either for or against the recognition of an association between SCI and urinary bladder cancer, were weighted according to their relevance. CONCLUSION: The results showed that urinary bladder cancer in SCI patients differs considerably from that of able-bodied patients. These differences drastically shorten the survival time. A study on patients with spina bifida, i.e., a congenital spinal cord disorder, corroborates these observations. They indicate histopathological differences that have so far been intangible.

[Neuro-urological diagnosis and therapy of lower urinary tract dysfunction in patients with spinal cord injury : S2k Guideline of the German-Speaking Medical Society of Paraplegia (DMGP), AWMF register no. 179/001]. / Neuro-urologische Diagnostik und Therapie bei Funktionsstörungen des unteren Harntrakts nach einer Rückenmarkschädigung : S2k-Leitlinie der Deutschsprachigen Medizinischen Gesellschaft für Paraplegie (DMGP), AWMF-Register Nr: 179/001.

BACKGROUND: Most patients with spinal cord injury (SCI) suffer from neurogenic lower urinary tract dysfunction (NLUTD), bowel dysfunction and sexual dysfunction. If these remain untreated, severe medical complications and serious limitations (restrictions) in quality of life are imminent. OBJECTIVES: In the long term, there are considerable differences in the treatment results of highly specialized centers versus other treatment facilities. MATERIALS AND METHODS: Against this background, a consensus-based guideline, according to the AWMF (Association of the Scientific Medical Societies in Germany) criteria (S2k), was developed by the neuro-urology working group of the DMPG (German-Speaking Medical Society of Paraplegia). RESULTS: The guideline defines the principles and objectives of the neuro-urological care of patients with SCI and discusses in detail the principles of diagnosis and therapy of NLUTD. The need for video-urodynamic studies as a basis for the classification of the NLUTD and as a foundation for the development of a treatment strategy is emphasized. Both conservative and surgical therapy options and their indications are explained in detail. Possible complications and their prevention in the long-term course of SCI are presented with a particular consideration of the specific features of urinary tract infections and autonomic dysreflexia. Finally, the principles of the provision of urological appliances are discussed. CONCLUSIONS: The presented S2k guideline provides the current standards in the neuro-urological care of patients with NLUTD due to SCI. Their consistent implementation both in the acute and chronic phase as well as in the context of lifelong surveillance of SCI patients should prevent the impending complications of NLUTD.

[Objective and subjective requirement of aids and appliances in patients with neurogenic lower urinary tract dysfunction : Multicenter study to determinate the daily necessity of urological aids and appliances]. / Objektiver und subjektiver Hilfsmittelbedarf bei Patienten mit neurogenen Harnblasenfunktionsstörungen : Multicenterstudie zur Ermittlung des täglichen Bedarfs an urologischen Hilfsmitteln.

BACKGROUND: The provision of urological appliances for patients with neurogenic lower urinary tract dysfunction (NLUTD) is essential. Hitherto existing standard guidelines for the estimation of monthly material requirements are based solely on estimates. OBJECTIVE: The goal of this work was to define the objective and subsequently subjective requirements for urological appliances on a scientifically validated basis. MATERIALS AND METHODS: Data concerning bladder management and daily consumption of urological appliances for patients with NLUTD were collected through a standardized survey at six different centers in Germany during the period of October to December 2014 and statistically evaluated. RESULTS: In all, 767 patient records were analyzed: 543 men and 221 woman (N/A = 3). The daily disposable catheter consumption of 577 patients who exclusively used intermittent catheterization was 5.13. Patients who used other means of bladder emptying (n = 31) in addition to catheterization consumed on average 3.17 catheters. The margin of deviation was larger for children. Of the 608 patients with intermittent catheterization, 94 (15.5 %) required additional paddings as absorbent aids (on average 2.29 paddings per day), 34 patients (5.6 %) additionally used pants (2.55 per day) and 46 patients (7.6 %) utilized condom catheters (3.81 per day) between catheterization. Among all surveyed patients, 126 (16.4 %) used paddings (5.03 per day) and 51 patients (6.6 %) pants (3.03 per day). Of all male respondents 82 (15.1 %) used condom catheters (2.80 urinary sheaths per day). CONCLUSION: Applying twice the standard deviation of the mean as a measure of assessing the objective requirement of urological appliances and aids for adult patients with NLUTD allows the following daily thresholds to be defined: 1-9 disposable catheters, 0-7 urinary sheaths, 1-9 paddings and 0-7 pants. These thresholds can serve as a basis for estimating the subjective need. They allow for a scientifically validated benchmark for an economically feasible and patient-tailored supply with urological aids and appliances. Individually required appliances and aids have to be recognized. Verifiable quality standards need to be developed.

[S2k guidelines of the German Society of Urology. Management and implementation of intermittent catheterization in neurogenic bladder dysfunction]. / S2k-Leitlinie der Deutschen Gesellschaft für Urologie. Management und Durchführung des intermittierenden Katheterismus bei neurogenen Blasenfunktionsstörungen.

BACKGROUND: As a considerable heterogeneity in the procedure of intermittent catheterization (IC) was identified by a questionnaire survey conducted in hospitals and institutions for the treatment of patients with spinal cord injury in 2010, it became necessary to standardize the IC procedure (i.e. self-catheterization and assisted catheterization). METHOD: These guidelines were developed within a structured consensus process (e.g. several consensus conferences and nominal group process) by members of the working group on neurourology (Arbeitskreis Neuro-Urologie) and the working group on nursing (Arbeitskreis Pflege) of the German-speaking Medical Society of Paraplegia (DMGP), a section of the German Society for Orthopedics and Traumatology (DGOU) and were published as S2k guidelines of the German Society of Urology (DGU). The guidelines developer group consisted of representatives from the following professional groups: neurourology, surgery, health and nursing, nursing science, urotherapy and hygiene. RESULTS: Firstly, the indications for IC are presented and concepts such as sterile, aseptic and hygienic catheterization are defined. The materials necessary for the IC (e.g. quality of the customized single-use catheter and approved disinfectants for disinfection of the meatus) are presented in detail. The disinfection and catheterization techniques are described and a detailed explanation of the potential complications and their management is given. Finally, the legal aspects and issues of eligibility of catheter material and disinfectants are discussed. CONCLUSIONS: The purpose of this consensus is to contribute to the standardization of IC. It should remove uncertainty and offer assistance to users (i.e. patients, staff and care providers). A particular focus is placed on practical instructions for carrying out the IC. The intention is to support the realization of IC in various settings (e.g. hospital, rehabilitation, long-term care institutions and home-based care). A wide implementation of the guidelines should lead to a reduction of the risks and complications of IC, which in most cases is a procedure that will be necessary throughout life.

[Diagnosis of neurogenic bladder dysfunction]. / Diagnostik der neurogenen Blasenfunktionsstörung.

Patients with congenital and acquired neurogenic bladder dysfunction due to central and peripheral nervous lesions are significantly limited in their daily lives. The neurogenic dysfunction of the bladder and lower urinary tract are often misinterpreted and later fed to a diagnosis. Without therapy severe complications, including renal damage, could be the consequence in the follow up. Therefore, dedicated diagnostics have to be done to recognize the different disorders and to determine the specific therapy. For these patients a lifelong bladder monitoring and neuro-urological management is necessary. This article describes techniques of neuro-urological testings and the interpretation in case of neurogenic disorders.