Javier C Angulo1,2, Sonia Ruiz3,4, Martín Lozano3,4, Ignacio Arance3,4, Miguel Virseda3,4, David Lora5. 1. Departamento Clínico, Universidad Europea de Madrid, Madrid, Spain. javier.angulo@salud.marid.org. 2. Servicio de Urología, Hospital Universitario de Getafe, Carretera de Toledo Km 12.5, 28905, Madrid, Spain. javier.angulo@salud.marid.org. 3. Departamento Clínico, Universidad Europea de Madrid, Madrid, Spain. 4. Servicio de Urología, Hospital Universitario de Getafe, Carretera de Toledo Km 12.5, 28905, Madrid, Spain. 5. Instituto de Investigación Sanitaria Hospital "12 de Octubre" (i+12), CIBER de Epidemiología y Salud Pública (CIBERESP), Universidad Complutense de Madrid, 28041, Madrid, Spain.
Abstract
OBJECTIVE: To assess the efficacy and safety of Adjustable Transobturator Male System (ATOMS) compared to male Readjustment Mechanical External (REMEEX) system for post-prostatectomy incontinence (PPI). MATERIAL AND METHODS: A systematic review and meta-analysis on adjustable device ATOMS compared to male REMEEX is presented. Studies on female or neurogenic incontinence were excluded. Primary objectives were evaluation of dryness (the proportion of patients with no-pad or one safety pad/day after device adjustment) and improvement between devices. Secondary objectives were complications and explant rate. They were estimated using a random-effect model. Statistical heterogeneity among studies was assessed using Cochran's Q test, Higgins's I2 statistics and tau2. RESULTS: Combined data of 29 observational studies with 1919 patients showed an equivalent proportion of patients treated with radical prostatectomy (p = .125) and previous radiation (p = .126). Dryness rate was 69.3% for ATOMS and 53.4% for male REEMEX (p = .008). Improvement rate was 90.8% for ATOMS and 80.2% for REMEEX (p = .007). Complication rate was 18.9% for ATOMS and 35.8% for REMEEX (p = .096) and explant rate was 5.5% for ATOMS and 13.9% for REMEEX (p = .027). Significant heterogeneity was evidenced, due to absence of randomized studies, variable incontinence severity baseline, difficulties for a common reporting of complications and difference in the follow-up. Differences observed between devices remained statistically significant when only studies with silicone-covered scrotal port (SSP) ATOMS and male REMEEX system II were considered. CONCLUSIONS: Despite the absence of direct comparison and the limitations observed ATOMS appears more effective than male REMEEX to treat PPI, and with less explant rate as reported in the literature.
OBJECTIVE: To assess the efficacy and safety of Adjustable Transobturator Male System (ATOMS) compared to male Readjustment Mechanical External (REMEEX) system for post-prostatectomy incontinence (PPI). MATERIAL AND METHODS: A systematic review and meta-analysis on adjustable device ATOMS compared to male REMEEX is presented. Studies on female or neurogenic incontinence were excluded. Primary objectives were evaluation of dryness (the proportion of patients with no-pad or one safety pad/day after device adjustment) and improvement between devices. Secondary objectives were complications and explant rate. They were estimated using a random-effect model. Statistical heterogeneity among studies was assessed using Cochran's Q test, Higgins's I2 statistics and tau2. RESULTS: Combined data of 29 observational studies with 1919 patients showed an equivalent proportion of patients treated with radical prostatectomy (p = .125) and previous radiation (p = .126). Dryness rate was 69.3% for ATOMS and 53.4% for male REEMEX (p = .008). Improvement rate was 90.8% for ATOMS and 80.2% for REMEEX (p = .007). Complication rate was 18.9% for ATOMS and 35.8% for REMEEX (p = .096) and explant rate was 5.5% for ATOMS and 13.9% for REMEEX (p = .027). Significant heterogeneity was evidenced, due to absence of randomized studies, variable incontinence severity baseline, difficulties for a common reporting of complications and difference in the follow-up. Differences observed between devices remained statistically significant when only studies with silicone-covered scrotal port (SSP) ATOMS and male REMEEX system II were considered. CONCLUSIONS: Despite the absence of direct comparison and the limitations observed ATOMS appears more effective than male REMEEX to treat PPI, and with less explant rate as reported in the literature.
Entities:
Keywords:
Adjustable Transobturator Male System (ATOMS); Effectiveness; Explantation; Male Readjustment Mechanical External System (REMEEX); Male incontinence
Authors: Sandra Mühlstädt; Alexander Friedl; Nasreldin Mohammed; André Schumann; Karl Weigand; Felix Kawan; Christian Göllert; Christin Kahlert; Gerit Theil; Kersten Fischer; Paolo Fornara Journal: World J Urol Date: 2016-05-07 Impact factor: 4.226
Authors: M R Hoda; G Primus; A Schumann; K Fischereder; B von Heyden; N Schmid; V Moll; A Hamza; J J Karsch; F Steinbach; C Brössner; W Bauer; P Fornara Journal: Urologe A Date: 2012-11 Impact factor: 0.639
Authors: M Grabbert; T Hüsch; A Kretschmer; R Kirschner-Hermanns; R Anding; A Rose; A Friedl; A Obaje; A Heidenreich; B Brehmer; C M Naumann; F Queissert; H Loertzer; J Pfitzenmaier; J Nyarangi-Dix; M Kurosch; R Olianas; R Homberg; R Abdunnur; J Schweiger; T Hofmann; C Wotzka; T Pottek; W Huebner; A Haferkamp; R M Bauer Journal: World J Urol Date: 2018-10-19 Impact factor: 4.226
Authors: Alexander Friedl; Wilhelm Bauer; Maximilian Rom; Danijel Kivaranovic; Werner Lüftenegger; Clemens Brössner Journal: Arch Ital Urol Androl Date: 2016-01-14
Authors: M Raschid Hoda; Günter Primus; Katja Fischereder; Burkhard Von Heyden; Nasreldin Mohammed; Norbert Schmid; Volker Moll; Amir Hamza; Johannes J Karsch; Clemens Brössner; Paolo Fornara; Wilhelm Bauer Journal: BJU Int Date: 2012-11-27 Impact factor: 5.588
Authors: Javier C Angulo; Sandra Schönburg; Alessandro Giammò; Francisco J Abellán; Ignacio Arance; David Lora Journal: PLoS One Date: 2019-12-02 Impact factor: 3.240