VACS Device Clinical Study for Incontinence Treatment

NACompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

January 7, 2022

Primary Completion Date

July 5, 2023

Study Completion Date

October 6, 2023

Conditions
Urinary Incontinence
Interventions
DEVICE

TOT

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.

DEVICE

VACS-D

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.

Trial Locations (2)

34093

Department of Gynecology and Obstetrics, Department of Surgical Medical Sciences, Istanbul Faculty of Medicine, Istanbul

35100

Ege University Faculty of Medicine, Department of Obstetrics and Gynecology, Izmir

All Listed Sponsors
lead

Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.

INDUSTRY

NCT06173180 - VACS Device Clinical Study for Incontinence Treatment | Biotech Hunter | Biotech Hunter