Systematic review and meta-analysis comparing Adjustable Transobturator Male System (ATOMS) and Adjustable Continence Therapy (ProACT) for male stress incontinence


Autoři: Javier C. Angulo aff001;  Sandra Schönburg aff003;  Alessandro Giammò aff004;  Francisco J. Abellán aff001;  Ignacio Arance aff001;  David Lora aff005
Působiště autorů: Departamento Clínico, Universidad Europea de Madrid, Madrid aff001;  Servicio de Urología, Hospital Universitario de Getafe, Madrid, Spain aff002;  Department of Urology and Kidney Transplantation, Martin Luther University, Halle (Saale), Germany aff003;  Department of Neuro-Urology, CTO-Spinal Unit, Città della Salute e della Scienza di Torino, Turin, Italy aff004;  Instituto de Investigación Sanitaria Hospital "12 de Octubre" (i+12), Madrid, Spain aff005;  CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain aff006;  Universidad Complutense de Madrid, Madrid, Spain aff007
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: 10.1371/journal.pone.0225762

Souhrn

Background and purpose

Urinary incontinence is one of the most serious complications of prostate cancer treatment. The objective of this study was to assess efficacy and safety of Adjustable Transobturator Male System (ATOMS) compared to Adjustable Continence Therapy (proACT) for male stress urinary incotinence according to literature findings.

Material and methods

A systematic review and meta-analysis on adjustable devices ATOMS and ProACT is presented. Studies on female or neurogenic incontinence were excluded. Differences between ATOMS and proACT in primary objective: dryness status (no-pad or one safety pad/day) after initial device adjustment, and in secondary objectives: improvement, satisfaction, complications and device durability, were estimated using random-effect model. Statistical heterogeneity among studies included in the meta-analysis was assessed using tau2, Higgins´s I2 statistics and Cochran´s Q test.

Results

Combined data of 41 observational studies with 3059 patients showed higher dryness (68 vs. 55%; p = .01) and improvement (91 vs. 80%; p = .007) rate for ATOMS than ProACT. Mean pad-count (-4 vs. -2.5 pads/day; p = .005) and pad-test decrease (-425.7 vs. -211.4 cc; p < .0001) were also significantly lower. Satisfaction was higher for ATOMS (87 vs. 56%; p = .002) and explant rate was higher for proACT (5 vs. 24%; p < .0001). Complication rate for ProACT was also higher, but not statistically significant (17 vs. 26%; p = .07). Mean follow-up was 25.7 months, lower for ATOMS than ProACT (20.8 vs. 30.6 months; p = .02). The rate of working devices favoured ATOMS at 1-year (92 vs. 76; p < .0001), 2-years (85 vs. 61%; p = .0008) and 3-years (81 vs. 58%; p = .0001). Significant heterogeneity was evidenced, due to variable incontinence severity baseline, difficulties for a common reporting of complications, different number of adjustments and time of follow-up and absence of randomized studies.

Conclusions

Despite the limitations that studies available are exclusively descriptive and the follow-up is limited, literature findings confirm ATOMS is more efficacious, with higher patient satisfaction and better durability than ProACT to treat male stress incontinence.

Klíčová slova:

Cancer treatment – Incontinence – Medical devices and equipment – Patients – Publication ethics – Surgical and invasive medical procedures – Systematic reviews


Zdroje

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