VACS Device Clinical Study for Incontinence Treatment: Follow up Study

NCT07483138 | Completed DMC

• 1 other identifier: VACS-D 002
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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, the aim is an evaluation of the efficacy of vacs-minifiks in the surgical treatment of stress urinary ıncontinence 24 months post-operatively.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

• One-Hour Pad Testing

  This test is performed in a clinical setting. They include a filling phase, during which the patient spends 15 minutes drinking 500 ml of fluid. This is followed by a series of provocative maneuvers, such as coughing and jumping, to try to stimulate urinary leakage. Pads are weighed before and at the end of the test. Pad loss ≥ 2 g is designated as significant or a 'positive pad test.

  after 24 months

• Evaluation of Quality of Life

  The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores.

  after 24 months

• Cough Stress Test

  A cough stress test (CST) is a simple, non-invasive diagnostic procedure used, primarily in women, to identify stress urinary incontinence (SUI). During the test, a patient with a comfortably full bladder coughs or strains while a healthcare provider directly observes for urine leakage, which confirms the diagnosis.

  after 24 months

Secondary Outcomes (6)

• Symptomatic Assessment for Overactive Bladder

  after 24 months

• Assess the Impact of the Dysfunction on Quality of Life

  after 24 months

• Symptomatic Impact Assessment

  after 24 months

• Assessment of Sexual Function

  after 24 months

• Assessment of Sexual Function during Intercourse

  after 24 months

Study Arms (2)

VACS-D

During the surgical procedure, this group operated with VACS-Minifiks.

TOT

During the surgical procedure, this group operated with the commercially available Transobturator Tape (TOT).

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

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

Istanbul, 34093, Turkey (Türkiye)

Location

Ege University Faculty of Medicine, Department of Obstetrics and Gynecology

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cenk Yasa, Professor

  Istanbul Faculty of Medicine, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Gokay Ozceltik

  Ege University Faculty of Medicine Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Ozgur Yeniel

  Ege University Faculty of Medicine Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: February 4, 2025
• Primary Completion: December 25, 2025
• Study Completion: March 10, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)