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VACS Device Clinical Study for Incontinence Treatment

NCT06173180 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-12-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.

    lead INDUSTRY

Principal Investigators

  • Cagdas Sahin, Assoc. Prof. · Ege University Faculty of Medicine Department of Obstetrics and Gynecology

  • Cenk Yasa, Professor · Istanbul Faculty of Medicine, Department of Obstetrics and Gynecology

  • Ozgur Yeniel, Professor · Ege University Faculty of Medicine Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2023-07-05
Completion
2023-10-06

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173180 on ClinicalTrials.gov