Status:
COMPLETED
VACS Device Clinical Study for Incontinence Treatment
Lead Sponsor:
Soranus ArGe ve Danismanlik Hizmetleri Sanayi Ticaret A.S.
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
40-65 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06173180
Start Date
January 7 2022
End Date
October 6 2023
Last Update
December 15 2023
Active Locations (2)
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1
Department of Gynecology and Obstetrics, Department of Surgical Medical Sciences, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye), 34093
2
Ege University Faculty of Medicine, Department of Obstetrics and Gynecology
Izmir, Turkey (Türkiye), 35100