Mid-term safety and efficacy of the ALTISA (R) single-incision sling for female stress urinary incontinence: less mesh, same results

Autores de IIS La Fe

• Eduardo José Morán Pascual

  Autor

• Juan Pérez Artacho

  Autor

• Jose Vicente Sanchez Gonzalez

  Autor

• Miguel Ángel Bonillo García

  Autor

• María Esther Martínez Cuenca

  Autor

• Salvador Arlandis Guzmán

  Autor

• Enrique Broseta Rico

  Autor

• Francisco Boronat Tormo

  Autor

Grupos

• Núcleo de investigación traslacional integrado Urológico de Valencia (NITIUV)

  

  Leader

  César David Vera Donoso

• Urología

  Leader

  Francisco Boronat Tormo

Abstract

Objective To analyse the mid-term safety and efficacy of the ALTISA (R) single-incision sling (Coloplast Corp., Minneapolis, MN, USA) for female stress urinary incontinence (SUI). Patients and Methods We conducted a prospective, single-arm, unsponsored, observational single-centre trial in a cohort of patients undergoing SUI surgery with the ALTIS procedure. All patients were diagnosed according to clinical reports, physical exploration and urodynamics. Body mass index (BMI) was categorised according to World Health Organization classification. Valsalva leak-point pressure (VLPP) was categorised in three groups: <60, 60-90 and >90 cmH(2)O. Patients were evaluated postoperatively at 1, 6, 12 and 24 months with physical examination, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and satisfaction visual scale (SVS; score 0-10). Adverse events were assessed at each visit. Multivariate analysis for risk factors of surgery failure was performed. Results We recruited 110 women, with a mean (SD) follow-up of 22.34 (10.34) months. Regarding efficacy, 91 patients (82.7%) were objectively cured and 97 (88.2%) were subjectively cured. Regarding VLPP and BMI, no differences were seen between groups (P > 0.05). There was a similar to 20% decrease in urge UI (P = 0.04). No variable showed to be an independent risk factor for ALTIS failure (P > 0.05). Overall, nearly 96% of the women reported 9 or 10 points on the SVS. A total of 24 patients (21.8%) had some kind of complication. No mesh erosion was reported in any patient. Conclusions The ALTIS sling demonstrated to be an effective and safe procedure for SUI in the mid-term setting. Objective and subjective cure rates are at least comparable to 'gold standard' procedures with a minimal rate of self-limiting non-surgical complications.

Keywords

• stress urinary incontinence; single-incision sling; efficacy; mid-term; safety; #Incontinence