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.
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.
Authors: René P Schellart; Sandra E Zwolsman; Jean-Philippe Lucot; Dirk J M K de Ridder; Marcel G W Dijkgraaf; Jan-Paul W R Roovers Journal: Int Urogynecol J Date: 2017-06-02 Impact factor: 2.894
Authors: René P Schellart; Katrien Oude Rengerink; Frank Van der Aa; Jean-Philippe Lucot; Bart Kimpe; Marcel G W Dijkgraaf; Jan-Paul W R Roovers Journal: Int Urogynecol J Date: 2015-12-15 Impact factor: 2.894