VACS Device Clinical Study for Incontinence Treatment
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      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, it is aimed to
      evaluate the effectiveness and safety of a newly developed, innovative medical device, as
      compared to TOT, in the patients diagnosed with urinary incontinence and requiring the
      surgical intervention.
    

Detailed description: 
      The study is an open-label, prospective, parallel-group, randomized, controlled medical
      device clinical trial, conducted in two centers. The two arms of the trial consist of
      patients randomized to the new device group and to the TOT group. According to this
      distribution, one group will be subjected to the operation with the new device, and the other
      group will be subjected to the operation with a commercially available TOT. Primary
      objective: Evaluation of the effectiveness of using the new device in the surgical treatment
      of urinary incontinence. Secondary objectives: Evaluation of the effects of the new device
      use on patients' quality of life, treatment satisfaction, and sexual functions, as well as
      assessment of safety. The study includes evaluation of the progress employing objective (pad
      weight, number of incontinence episodes, urodynamic tests) and subjective tests
      (questionnaires, diaries) during the 12 months follow-up period.
    

Intervention name(s): TOT; VACS-D
Intervention type(s): Device; Device
Intervention description(s): In the Transobturator Tape-TOT operation, the anterior vaginal wall is incised 2 cm sagittal 1.5 cm below the urethra in the dorsal lithotomy position and the paraurethral areas are separated by sharp and blunt dissection and the ischiopubic bone is reached with the finger. The skin is incised so as to remain 1 cm lateral to the ischiopubic ramus on the line passing through the clitoris, and the synthetic tape is placed from outside to inside with special inclined trocars, passing under the urethra close to the medial part of the obturator foramen. Cystoscopy is not performed during the procedure. The vagen mucosa is sutured and the procedure is terminated by inserting a urethral foley catheter. The urethral catheter is removed on postoperative day 1 after the investigator evaluates the patient.; The VACS-Minifiks procedure is a vaginal application of a natural tissue repair procedure whose efficacy has been proven in the abdominal route. The second difference is that the procedure is performed through a single incision instead of the three incisions used in the Transobturator Tape-TOT operation. Thus, the same goal will be achieved in a less invasive way without placing an artificial permanent implant. There is no difference in parameters such as anesthesia, operation time, and discharge time.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were randomized into two groups and underwent surgery.
Masking: None (Open Label)
Primary purpose: Treatment