VACS Device Clinical Study for Incontinence Treatment: Follow up Study

For this planned follow-up study, 57 patients (28 VACS-D and 29 TOT patients) who had been enrolled in the study designated as VACS-D-which was completed in October 2023 in accordance with the study protocol-and who had completed their final follow-up visits (the 6-12-month follow-up visit) were invited to participate. Those volunteers who agreed to participate were included in this study. The study was designed to include a single visit. During this visit, the patients' medical histories were taken. Body weight measurements will be taken, and volunteers will be asked to complete certain questionnaires/surveys to assess their quality of life, sexual function, and treatment satisfaction (Incontinence Quality of Life Scale (I-QOL), Female Sexual Function Index (FSFI), Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), Overactive Bladder Questionnaire (OAB-V8), Urinary Sympthomatic Questionnaire, and Short Form of Patient Satisfaction Assessment (PSS) to assess their quality of life, sexual function, and treatment satisfaction. In addition to these, post-void residual urine volume (PVR) measurements will be performed via ultrasound. Furthermore, volunteers were asked to keep a three-day bladder diary. If there were findings suggesting a urinary tract infection, a complete urinalysis was performed; if deemed necessary by the physician, a Urine Culture and Antibiogram test was also conducted. Volunteers in whom a urinary tract infection was detected during the study visit were evaluated after completing treatment for the infection. Information was recorded for patients who received incontinence treatment and/or underwent incontinence surgery during the postoperative period. Statistical analysis was performed.