title: Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow-up.
abstract: OBJECTIVE
  The primary outcome of this study was to evaluate the subjective and objective outcomes of an adjustable Single Incision Sling (Ajust™ C.R. Bard Inc., New Providence, NJ, USA) for the treatment of SUI, with a 2-year follow-up. The secondary outcome was to evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder.
  
  
  METHODS
  In our prospective multicenter study we included 95 females with a clinical symptomatic and urodynamic diagnosis of primary SUI, and unsuccessful previous conservative treatment. Cure rate was evaluated objectively, using a standardized cough stress test and subjectively using the patient global impression of improvement. The King's Health questionnaire was used to evaluate quality of life (QoL). Urgency was evaluated using the patient perception of intensity of urgency scale. Complications were assessed intra-, peri- and post-operatively. All patients underwent urodynamic studies pre-operatively and at 6 months. The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Fisher exact test for continuous non-parametric variables. A logistic regression model and odds ratios (with 95 percent confidence intervals) were used to assess the independent prognostic value of four variables for the outcome (age, parity, body mass index and menopausal status).
  
  
  RESULTS
  92 Patients completed the 2-year follow-up. The objective cure rate was 83.7% and the subjective cure rate was 81.5%. De novo urgency was present in 9 patients (9.8%) and was associated with de novo urge incontinence in 6 patients (6.5%). Only 1 patient with de novo urge incontinence showed de novo detrusor overactivity. Regarding QoL, the King's Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, 3 patients had mesh extrusions, 1 patient had recurrent urinary tract infections. Post-operative urodynamics showed a statistically significant increase of detrusor pressure at maximum flow and a reduction of maximum flow rate. No patients were obstructed according to the Blaivas and Groutz nomogram.
authors.affiliation: Department of Urogynecology-S. Carlo-IDI Hospital, Rome, Italy. Electronic address: f.natale@idi.it.
authors.forename: Franca
authors.initials: F
authors.lastname: Natale
authors.affiliation: Unit of Urogynecology, "Casilino" General Hospital, Rome, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Dati
authors.affiliation: Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: La Penna
authors.affiliation: Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Rombolà
authors.affiliation: Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Cappello
authors.affiliation: Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Piccione
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D053825:Suburethral Slings / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000503:physiopathology; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D053202:Urinary Incontinence, Urge / Q000601:surgery; D014563:Urodynamics
keywords: Quality of life; Single incision sling; Stress urinary incontinence; Surgery; Urodynamics