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VACS Device Clinical Study for Incontinence Treatment

NCT ID: NCT06173180

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2023-10-06

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants were randomized into two groups and underwent surgery.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VACS-Minifiks (VACS-D)

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

Group Type ACTIVE_COMPARATOR

VACS-D

Intervention Type 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.

Transobturator Tape (TOT)

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

Group Type ACTIVE_COMPARATOR

TOT

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
* After physical and neurological examination inclusion in the study was made by the researcher. eligible patients
* 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)

Exclusion Criteria

* 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
* Negative, as determined by the researcher benefit/risk ratio
* Any research in the previous 30 days treatment (medication or device) has been received.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cagdas Sahin, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Ege University Faculty of Medicine Department of Obstetrics and Gynecology

Cenk Yasa, Professor

Role: PRINCIPAL_INVESTIGATOR

Istanbul Faculty of Medicine, Department of Obstetrics and Gynecology

Ozgur Yeniel, Professor

Role: STUDY_DIRECTOR

Ege University Faculty of Medicine Department of Obstetrics and Gynecology

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Ege University Faculty of Medicine, Department of Obstetrics and Gynecology

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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VACS-D 001

Identifier Type: -

Identifier Source: org_study_id