VACS Device Clinical Study for Incontinence Treatment

NCT06173180 | Completed DMC

• 1 other identifier: VACS-D 001
• Study Type: interventional
• Target: 67
• 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, 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

Urinary Incontinence

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline, 6 weeks, 3 months, 6 months, 12 months

• Twenty-Four-Hour Pad Testing

  This test is performed at home. Women are provided with a set of pads and advised not to modify their normal drinking or activities. The aim of such tests is to document leakage in a normal home environment. Pad loss greater than 4 g is designated as significant or a 'positive pad test'.

  Baseline, 6 weeks, 3 months, 6 months, 12 months

• Number of Total Daily Incontinence Episodes

  It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.

  6 weeks, 3 months, 6 months, 12 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.

  Baseline, 6 weeks, 12 months

• Urodynamic Assessment

  The bladder is filled using the catheter and pressure measurements are continuously recorded and patient feedback regarding bladder sensation and urgency. Testing for stress incontinence is performed with coughing and straining. Leak Point Pressure and leakage episodes are recorded and analyzed to provide information regarding the type and severity of incontinence. At the end of the test, urine is passed to assess bladder function further and look for blockage of urinary flow.

  Baseline, 12 months

Secondary Outcomes (7)

• Symptomatic Assessment for Overactivitive Bladder

  Baseline, 12 months

• Assess the Impact of the Dysfunction on Quality of Life

  Baseline, 12 months

• Symptomatic Impact Assessment

  Baseline, 12 months

• Assessment of Sexual Function

  Baseline, 12 months

• Assessment of Sexual Function during Intercourse

  Baseline, 12 months

Study Arms (2)

VACS-Minifiks (VACS-D)

ACTIVE COMPARATOR

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

Device: VACS-D

Transobturator Tape (TOT)

ACTIVE COMPARATOR

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

Device: TOT

Interventions

TOT DEVICE

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.

Transobturator Tape (TOT)

VACS-D DEVICE

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.

VACS-Minifiks (VACS-D)

Eligibility Criteria

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

You may qualify if:

• Those who have not received radiotherapy
• Women aged 40-65 years
• Accompanying infection according to urine culture results people who do not
• Informed about the study and participated in the study patients who have agreed to participate
• Acceptable contraception during work agree to continue to apply their methods those who
• According to the urodynamic test results, the researcher appropriate to be included in the study by patients with
• Previous response to standard treatments (medication, etc.) non-responders (non-responders to methods such as pelvic floor muscle exercises (with or without physical therapy), behavioral and lifestyle modifications, continence-assisted pessaries, and pharmacotherapy)

You may not qualify if:

• Women who are pregnant, supported by biochemical laboratory findings
• Those in the urinary incontinence category other than SUI
• Those with significant pelvic organ prolapse (e.g., cystocele, rectocele); (as defined by the International Continence Society greater than phase II)
• Those with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
• Patients with morbid obesity (BMI greater than 40 Those who are)
• Those with abnormal bladder capacity (more than 300 cc large)
• Those with abnormal post-void residuals (50 greater than cc)
• Urethral stricture and bladder neck contracture Those who are
• Spastic bladder
• Those with urinary tract infection (UTI)
• Those with vesicoureteral reflux
• Those with bladder stones
• Those with bladder tumors
• Difficulty understanding and adapting to work is mentally healthy to the extent that it can create patients without
• Fulfill the requirements of the work plan who may have trouble adapting to bring patients

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

• Cagdas Sahin, Assoc. Prof.

  Ege University Faculty of Medicine Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Cenk Yasa, Professor

  Istanbul Faculty of Medicine, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Ozgur Yeniel, Professor

  Ege University Faculty of Medicine Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The participants were randomized into two groups and underwent surgery.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 15, 2023
• Study Start: January 7, 2022
• Primary Completion: July 5, 2023
• Study Completion: October 6, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

TU (2)