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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT05534269
Eligibility Criteria:
Inclusion Criteria:
* Predominant clinical diagnosis of SUI
* Stress incontinence ≥ grade I for at least 6 months
* Patient has at least once been treated with, and failed prior conservative treatments
* Patient had no improvement of SUI symptoms for at least 6 months before enrollment
* Patients with a certain amount of leaks or /and a predefined pad weight at screening
* Candidate for a surgical treatment
* Negative blood test: Human immunodeficiency virus (HIV 1/2), Hepatitis B HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab and Syphilis
* Negative laboratory or blood test, and medical examination to eliminate risk of sexually transmitted diseases (STD) per investigators' discretion
* Competent to comprehend, sign, and date informed consent form before any study-specific procedure is performed
* Able to communicate well with the Investigator, and to understand and comply with the requirements of the study including answering the required questionnaires
Exclusion Criteria:
* History of anti-incontinence surgery or prolapse surgery.
* Prolapse
* Diagnosed Hypermobile Urethra
* Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
* Clinically significant cystocele or rectocele
* Ureteric bladder, urethral or rectal fistula
* Uncorrected congenital abnormality leading to urinary incontinence
* Interstitial cystitis
* Urinary urgency that results in leakage (as a predominant symptom)
* Adult enuresis
* Urodynamically proven detrusor instability or detrusor sphincter dyssynergia (DSD)
* Sensory urgency defined as first sensation of bladder fill (urge to void) of \<100 ml
* No sensation at any time during the simple filling cystometry procedure
* Known urethral Stenosis (ureterocystoscopy) or urethral diverticulum
* History of cancer (\< 5 year of remission) or history of pelvic radiotherapy
* Immunosuppressed patients
* Women who are pregnant or become pregnant during the course of the study, breast feeding or \<12 months postpartum
* Untreated symptomatic urinary tract infection
* Fever (as defined by ≥ 38,5°C, axillar measurement), any infectious disease, cold or flu within the last 7 days
* Unstable severe systemic disease including uncontrolled hypertension, unstable angina, or myocardial infarction, severe coagulation disorders, bleeding diathesis, emboli, thrombophlebitis, infectious diseases, poor wound healing, and poorly controlled diabetes mellitus within 6 months before enrolment
* Known allergy/intolerance to at least one of the active ingredients or excipients of the investigational products
* Known allergy/intolerance to Penicillin or Streptomycin.
* Known genetically determined or acquired muscular disease, known neurological disorder (Parkinson's disease, multiple sclerosis, spina bifida, medullary traumatism, Creutzfeldt-Jakob disease).
* Medication regimen including estrogens, anti-estrogens or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks or is anticipated to change during the course of the study.
* Chronic use of defined drugs and not stopped prior to inclusion into or including the study. Selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), alpha-receptor antagonists/agonists, beta-3-receptor agonists or anticholinergic/-muscarinic drugs.
* Have any clinically significant coexisting condition or symptoms that, in the opinion of the investigator, would put the safety of the participant at risk.
* Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
* Medication known to affect lower urinary tract function.
* Patients having any electrical device inside their body (such as a cochlear implant, TENS stimulator (for pain), vagal nerve stimulator, brain stimulator, gastric pacemaker, bladder stimulator, or an implanted mechanical pump (such an insulin pump or pain pump).
* Patients having a cardiac pacemaker or defibrillator implant.
* Patients with Starr-Edwards artificial heart valve.
* Patients that suffer from claustrophobia.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05534269
Study Brief:
Protocol Section:
NCT05534269