VACS Device Clinical Study for Incontinence Treatment (VACS-D)

SoranusMED

Status

Completed

Conditions

Urinary Incontinence

Treatments

Device: TOT

Device: VACS-D

Study type

Interventional

Funder types

Industry

Identifiers

NCT06173180

VACS-D 001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

67 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.