Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT03958695
Eligibility Criteria:
Inclusion Criteria:
* The subject is a woman with stress urinary incontinence or urodynamic mixed urinary incontinence with predominate SUI
* The subject is at least 18 years of age
* The subject has failed conservative treatment for at least 6 months
* The subject gave written consent to participate in the study,
Exclusion Criteria:
* The subject has an active urinary tract infection or skin infection in the region of surgery
* The subject has pelvic organ prolapse (POP) stage 2 or higher according to Pelvic Organ Prolapse Quantification system (POP-Q)
* The subject had prior surgery for SUI or POP
* The subject has predominate urge urinary incontinence
* The subject has a urogenital fistula, anatomical defect, stricture, diverticulum, new growth or any kind of abnormalities of the urethra
* The subject has chronic pelvic pain
* The subject has a system neurological disease, such as Parkinson's disease, Alzheimer disease and other dementias, multiple sclerosis, epilepsy etc
* The subject has pelvic cancer or the subject has undergone radiotherapy for treating pelvic cancer
* The subject has post void residual (PVR) \>50 ml
* The subject has dysfunctional voiding and average flow rate (Qave) \< 12 ml/s
* The subject is pregnant or disagrees to abstain from the pregnancy during the study
* The subject has any mental disorders affecting his ability to evaluate the risks of the treatment and make an independent decision on participation in the study
* The subject has an allergy on local anesthetics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03958695
Study Brief:
Protocol Section:
NCT03958695