VACS Device Clinical Study for Incontinence Treatment: Follow up Study

Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women: Long-term Follow-up Study

Stress Urinary Incontinence (SUI) is a common health condition in the female population. Mid-urethral slings (MUS) have proven to be effective in the treatment of female SUI. Trans-obturator tape (TOT) has been demonstrated to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. In this study, the aim is an evaluation of the efficacy of vacs-minifiks in the surgical treatment of stress urinary ıncontinence 24 months post-operatively.

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.

Inclusion Criteria:

• Patients who participated in the study titled "Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women" (protocol code VACS-D) and completed their final follow-up visit (the 6-12-month visit).
• Volunteers who are willing to participate, have been informed about the study, and have provided a signed informed consent form (ICF), stating that they can comply with the requirements and restrictions listed in the ICF and this protocol.

Exclusion Criteria:

• Having received radiotherapy during the postoperative period as part of the VACS-D study.
• Women who are pregnant based on the results of a urine pregnancy test.
• Those who have been enrolled in any other clinical trial following the VACS-D protocol study.