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Improved emptying performance with a new micro-hole zone catheter in adult male intermittent catheter users: A comparative multi-center randomized controlled cross-over study.

التفاصيل البيبلوغرافية
العنوان: Improved emptying performance with a new micro-hole zone catheter in adult male intermittent catheter users: A comparative multi-center randomized controlled cross-over study.
المؤلفون: Thiruchelvam N; Department of Urology, NHS Foundation Trust, Addenbrooke's Hospital, Cambridge University Hospital, Cambridge, UK., Landauro MH; Coloplast A/S, Humlebaek, Denmark., Biardeau X; Centre Hospitalier Universitaire de Lille, Lille Cedex, France., Rovsing C; Sanos Clinic, Gandrup, Denmark., Hahn M; ARTIMED Medical Consulting GmbH, Kassel, Germany., Nascimento OFD; Coloplast A/S, Humlebaek, Denmark., Gardner S; Hazelwood House, Macclesfield, UK., Amarenco G; Department of Neuro-Urology, Tenon Hospital, Paris, France., Bagi P; Department of Urology, Rigshospitalet, København Ø, Denmark.
المصدر: Neurourology and urodynamics [Neurourol Urodyn] 2024 Feb; Vol. 43 (2), pp. 464-478. Date of Electronic Publication: 2024 Jan 09.
نوع المنشور: Randomized Controlled Trial; Multicenter Study; Journal Article
اللغة: English
بيانات الدورية: Publisher: Alan R. Liss Country of Publication: United States NLM ID: 8303326 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6777 (Electronic) Linking ISSN: 07332467 NLM ISO Abbreviation: Neurourol Urodyn Subsets: MEDLINE
أسماء مطبوعة: Original Publication: New York : Alan R. Liss, c1982-
مواضيع طبية MeSH: Urinary Tract Infections* , Intermittent Urethral Catheterization*/methods , Urinary Bladder, Neurogenic*/etiology , Urinary Bladder, Neurogenic*/therapy, Adult ; Humans ; Male ; Cross-Over Studies ; Hematuria ; Urinary Catheters ; Urinary Catheterization/methods
مستخلص: Aims: To confirm the improved performance of the micro-hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent catheterizations (CICs).
Methods: Male self-catheterizing subjects, who used hydrophilic sleeved soft/flexible CIC as the only bladder emptying method, were enrolled into a multi-center, randomized, cross-over study performed across six European sites. Subjects tested the MHZC, featuring a drainage zone with 120 micro-holes and a CEC with two eyelets. The study consisted of four study visits (V0-V3), during which endpoints related to catheter performance (urinary flow-stops, bladder emptying, and intra-catheter pressure) were measured and two 4-week test periods at home (T1 and T2) where dipstick hematuria and user perception between catheters were evaluated.
Results: Seventy-three male subjects with non-neurogenic and neurogenic bladder dysfunction (3:2) were enrolled. On average, catheterizations with the MHZC led to close to mean zero flow-stops compared to ≥1 flow-stops with the CEC, during both HCP- and self-led catheterizations (both p < 0.001). Residual urine at first flow-stop was significantly reduced for the MHZC compared to CEC (p = 0.001 and p = 0.004, for HCP- and self-led catheterizations, respectively). This was substantiated by a significantly smaller pressure peak at first flow-stop, a proxy for minimized mucosal suction (both HCP- and self-led catheterizations, p < 0.001). After home-use catheterizations, dipstick hematuria was comparable between catheters, whereas catheterizations were associated with significantly improved perception in favor of MHZC regarding bladder emptying, less blocking sensation, and improved hygienic catheterization compared to the CEC.
Conclusion: This study confirmed the evidence of improved bladder emptying with the MHZC compared to a CEC without the need to reposition the catheter. The MHZC therefore offers an enhanced benefit for the dependent CIC user securing complete bladder emptying in an uninterrupted free flow and reducing the need to reposition the catheter during emptying.
(© 2024 Coloplast A/S. Neurourology and Urodynamics published by Wiley Periodicals LLC.)
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فهرسة مساهمة: Keywords: clean intermittent catheterization; micro-hole drainage zone; urinary bladder disease; urinary flow-stop; urinary retention; urinary tract infection
تواريخ الأحداث: Date Created: 20240110 Date Completed: 20240206 Latest Revision: 20240206
رمز التحديث: 20240206
DOI: 10.1002/nau.25383
PMID: 38196237
قاعدة البيانات: MEDLINE
الوصف
تدمد:1520-6777
DOI:10.1002/nau.25383