Clinical trial NCT06173180: VACS Device Clinical Study for Incontinence Treatment
Official title: Clinical Evaluation of Vaginal Suture Knotting Device in the Treatment of Urinary Incontinence in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 67
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were randomized into two groups and underwent surgery.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: One-Hour Pad Testing
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months
measure: Twenty-Four-Hour Pad Testing
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months
measure: Number of Total Daily Incontinence Episodes
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Evaluation of Quality of Life
timeFrame: Baseline, 6 weeks, 12 months
measure: Urodynamic Assessment
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Symptomatic Assessment for Overactivitive Bladder
timeFrame: Baseline, 12 months
measure: Assess the Impact of the Dysfunction on Quality of Life
timeFrame: Baseline, 12 months
measure: Symptomatic Impact Assessment
timeFrame: Baseline, 12 months
measure: Assessment of Sexual Function
timeFrame: Baseline, 12 months
measure: Assessment of Sexual Function during Intercourse
timeFrame: Baseline, 12 months
measure: Post-Voiding Residual (PVR) Urine Volume
timeFrame: Baseline, 12 months
measure: Assessment of Serious Adverse Events and Adverse Events
timeFrame: Intraoperative, postoperative 6 weeks, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Department of Gynecology and Obstetrics, Department of Surgical Medical Sciences, Istanbul Faculty of Medicine
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine, Department of Obstetrics and Gynecology
Study officials:
affiliation: Ege University Faculty of Medicine Department of Obstetrics and Gynecology
name: Cagdas Sahin, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Faculty of Medicine, Department of Obstetrics and Gynecology
name: Cenk Yasa, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Faculty of Medicine Department of Obstetrics and Gynecology
name: Ozgur Yeniel, Professor
role: STUDY_DIRECTOR
References: