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Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow-up.
Eur J Obstet Gynecol Reprod Biol. 2014 Nov; 182:48-52.EJ

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.

STUDY DESIGN

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+Show Affiliations

Department of Urogynecology-S. Carlo-IDI Hospital, Rome, Italy. Electronic address: f.natale@idi.it.Unit of Urogynecology, "Casilino" General Hospital, Rome, Italy.Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy.Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy.Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy.Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy.

Pub Type(s)

Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

25233444

Citation

Natale, Franca, et al. "Single Incision Sling (Ajust™) for the Treatment of Female Stress Urinary Incontinence: 2-year Follow-up." European Journal of Obstetrics, Gynecology, and Reproductive Biology, vol. 182, 2014, pp. 48-52.
Natale F, Dati S, La Penna C, et al. Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow-up. Eur J Obstet Gynecol Reprod Biol. 2014;182:48-52.
Natale, F., Dati, S., La Penna, C., Rombolà, P., Cappello, S., & Piccione, E. (2014). Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow-up. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 182, 48-52. https://doi.org/10.1016/j.ejogrb.2014.08.011
Natale F, et al. Single Incision Sling (Ajust™) for the Treatment of Female Stress Urinary Incontinence: 2-year Follow-up. Eur J Obstet Gynecol Reprod Biol. 2014;182:48-52. PubMed PMID: 25233444.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow-up. AU - Natale,Franca, AU - Dati,Stefano, AU - La Penna,Chiara, AU - Rombolà,Pasquale, AU - Cappello,Stefania, AU - Piccione,Emilio, Y1 - 2014/08/15/ PY - 2014/03/16/received PY - 2014/06/13/revised PY - 2014/08/07/accepted PY - 2014/9/19/entrez PY - 2014/9/19/pubmed PY - 2015/11/3/medline KW - Quality of life KW - Single incision sling KW - Stress urinary incontinence KW - Surgery KW - Urodynamics SP - 48 EP - 52 JF - European journal of obstetrics, gynecology, and reproductive biology JO - Eur J Obstet Gynecol Reprod Biol VL - 182 N2 - 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. STUDY DESIGN: 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. SN - 1872-7654 UR - https://www.unboundmedicine.com/medline/citation/25233444/Single_incision_sling__Ajust™__for_the_treatment_of_female_stress_urinary_incontinence:_2_year_follow_up_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0301-2115(14)00434-5 DB - PRIME DP - Unbound Medicine ER -