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A prospective observational cohort study of the Ajust® single incision sling performed under conscious sedation with local infiltration
Author(s) -
Engberts Marian K.,
Schweitzer Karlijn J.,
Eijndhoven Hugo W. F.,
Cromheecke GeertJan,
Naber Harry R.,
Huub van der Vaart C.
Publication year - 2019
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.24027
Subject(s) - medicine , sedation , anesthesia , observational study , surgery , perioperative , urethra , local anesthesia , urinary incontinence
Aims To evaluate the adjustable single‐incision sling (Ajust®) in the treatment of stress urinary incontinence (SUI), when placed under conscious sedation with local infiltration, using the cough test during surgery. Methods In this multicenter observational study, 90 women who had moderate to severe SUI, were asked to have the Ajust® procedure performed under sedation with local infiltration with levobupivacain. This allowed for a perioperative cough test to adjust the sling to the urethra till continence was reached. The primary outcome of the study was subjective cure of stress incontinence at 1 year follow up. Secondary objectives were objective and subjective improvement, complications during and after the procedure, and postoperative pain scores. These results were compared with the results of a historical control group of 96 patients who received their Ajust® under general or regional (spinal) anesthesia. Results At 6 weeks and 12 months, there were no statistical significant differences in the results for subjective cure (83.6% and 71.6% sedation group, 88.4% and 77.2% general/regional anesthesia group), objective cure (96% and 86.9% sedation group, 88.1% and 91.8% general/regional anesthesia group), de novo urgency (10.5% and 6.7% sedation group, 7.1% and 24.1% general/regional anesthesia group) and the patients global impression of improvement (96% and 89.2% sedation group, 91.4% and 84.4% general/regional anesthesia group). Conclusion The performance of a cough test during the placement of an adjustable single‐incision sling for the treatment of SUI does not affect the functional outcome, and is therefore not necessary.