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Aims: Evaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months., Methods: This was a prospective, multi-center, industry-sponsored (Coloplast Corp.), single-arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6-months. Device- and procedure-related complications were collected for safety. Secondary measures included cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, and Patient Global Impression of Improvement., Results: Of the 113 women implanted, 94 remained at 24-months. The average procedure time was 12.8 ± 8.4 min across all settings. Of those with paired baseline and follow-up data at 24-months, 90.0% (81/90) achieved ≥50% reduction in pad weight, 81.1% (73/90) were dry (pad weight ≤4.0 g), and 87.9% (80/91) had a negative cough stress test. Significant median reductions of 44.4 in Urogenital Distress Inventory (P-value <0.0001) and 52.0 in Incontinence Impact Questionnaire scores (P-value <0.0001) were observed. Additionally, 90.4% (85/94) of subjects reported "very much better" or "much better" on the Patient Global Impression of Improvement. No new device- or procedure-related adverse events occurred between the 12 and 24 month visits., Conclusions: The Altis single-incision sling is a durable and effective treatment with a favorable safety profile for surgical treatment of women with stress or stress-predominant mixed urinary incontinence., (© 2016 Wiley Periodicals, Inc.)

Purpose: We describe the safety and efficacy of the Altis(®) Single Incision Sling System for the treatment of female stress urinary incontinence through 12 months., Materials and Methods: In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence. The primary efficacy end point was improvement in 24-hour pad weight test. Other efficacy measures included the cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, Patient Global Impression of Improvement and 3-day voiding diary. Safety was evaluated through assessment of device and procedure related adverse events., Results: Of 116 surgical attempts 113 subjects were implanted with the Altis sling. Of these patients 103 had primary efficacy data at baseline and 6 months, and 101 had efficacy data at baseline and 12 months. Consequently 88 (85.4%) subjects at 6 months and 91 (90.1%) at 12 months achieved a 50% or greater reduction in pad weight. The cough stress test was negative for 95 (92.2%) subjects at 6 months and 91 (90.1%) at 12 months. A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months. A majority of subjects reported feeling much better or very much better at 6 and 12 months, respectively. There were no reports of mesh erosion or migration and no unanticipated adverse events through 12 months., Conclusions: The Altis sling appears to be safe and efficacious, and performs as intended in the treatment of stress urinary incontinence through 12 months., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Study Objective: To report MiniArc single-incision sling efficacy results in the office setting and the feasibility of performing the procedure in the office., Design: Prospective, single-arm, nonrandomized, institutional review board-approved study (Canadian Task Force classification II-2)., Setting: Three in-office clinical sites in the United States., Patients: Thirty-eight patients who underwent treatment of stress urinary incontinence using the MiniArc single-incision sling., Intervention: A MiniArc single-incision sling was placed in 38 patients in an office-based setting under intravenous or oral sedation and/or local anesthesia., Measurements and Main Results: Thirty-eight implant recipients were evaluated for effectiveness and safety via qualitative (Urinary Distress Inventory-Short Form [UDI-6] and Incontinence Impact Questionnaire-Short Form [IIQ-7]) and quantitative (1-hour pad-weight test and cough stress test) measurements at 3 clinical sites. Secondary outcome measures included procedure time, estimated blood loss, length of stay, perioperative complications, Wong-Baker Faces Pain Scale, and adverse events. During the study, 38 women (mean [SD; 95% CI] age, 48.1 (8.4; 45.3-50.8 years)) received slings. Mean procedure time was 10.6 minutes, estimated blood loss was 23.2 mL, and length of stay was 1.3 hours. At discharge, the Wong-Baker pain score was 0.2 (0.0-2.0). At 2 years, 31 patients were available for follow-up. Of these, 93.5% had normal findings on the cough stress test, and 90.3% had pad weight <1 g; and 90.6% and 87.5%, respectively, using last failure carried forward analysis in 32 patients. The UDI-6 and IIQ-7 median scores showed a statistically significant decrease from baseline (p < .001). There were no reports of serious adverse events or of bowel, urethral, bladder, or major vessel perforation., Conclusion: The in-office experience suggests that implantation of a single-incision sling for treatment of stress urinary incontinence with the patient under intravenous or oral sedation and/or local anesthesia can be performed safely, with effective results. Thus, performing this procedure in an office setting is a viable option., (Copyright © 2012 AAGL. Published by Elsevier Inc. All rights reserved.)

Introduction and Hypothesis: This study was designed to evaluate clinical outcomes ≥2 years following surgery with polypropylene mesh and vaginal support device (VSD) in women with vaginal prolapse, in a prospective, multi-center setting., Methods: Patients re-consented for this extended follow-up (n = 110), with anatomic evaluation using Pelvic Organ Prolapse Quantification (POP-Q) and validated questionnaires to assess pelvic symptoms and sexual function. Complications were recorded (safety set; n = 121)., Results: Median length of follow-up was 29 months (range 24-34 months). The primary anatomic success, defined as POP-Q 0-I, was 69.1%; however, in 84.5% of the cases, the leading vaginal edge was above the hymen. Pelvic symptoms and sexual function improved significantly from baseline (p < 0.01). Mesh exposure rate was 9.1%. Five percent reported stress urinary incontinence and 3.3% required further prolapse surgery., Conclusion: These results indicate this non-anchored mesh repair is a safe and effective treatment for women with symptomatic vaginal prolapse in the medium term.