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:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT02023502
Eligibility Criteria:
Inclusion Criteria:
* patients with stress urinary incontinence: a history of symptoms of stress urinary incontinence for at least 3 months (including anamnestic complaints of involuntary leakage on effort or exertion or on sneezing or coughing) and a positive provocative stress test (defined as an observed transurethral loss of urine that was simultaneous with a cough or Valsalva maneuver at a bladder volume of 300ml or less)
* patients capable of independent toiling
* patients who are able to fully understand all study procedures and to provide written informed consent to study participation
* age ≥ 18
* patients after vaginal delivery
Exclusion Criteria:
* patients who have previously been treated for SUI (both surgical or pharmacological treatment)
* patients who have a medical history of uncontrolled overactive bladder (OAB) or urinary incontinence other than SUI (including anamnestic complaints on involuntary urine leakage accompanied by or immediately preceded by urgency, not stress induced)
* patients with well established neurological disorder (e.g. Multiple Sclerosis, Parkinson's disease, Alzheimer's disease)
* patients with pelvic organ prolapse stage ≥ II (ICS classification)
* patients with a clinically significant bladder outlet obstruction and/or patients with a post void residual volume (PVR) \> 100ml
* patients with a history of acute urinary retention or history of repeated catheterizations due to acute urinary retention within the last 3 months prior to the day of informed consent
* patients with an indwelling catheter and patients practicing intermittent self- catheterization
* patients who have undergone a bladder biopsy or any other minor pelvic surgical intervention less than 30 days prior to the day of informed consent
* patients with a history of bladder cancer
* patients with acute or recurrent urinary tract infection and/or unexplained haematuria
* patients with stone(s) in the bladder or urethra and upper tract stone disease causing symptoms
* patients with evidence of renal insufficiency (creatinine \> 1.5x upper limit of normal)
* patients with evidence of hepatic disease (total bilirubin \>1.5x upper limit of normal, or AST or ALT or alkaline phosphatase \>2x upper limit of normal)
* patients with a history of alcohol and/or other drug abuse
* patients who are unable and/or unlikely to comprehend and follow the study procedures and instructions
* patients who are pregnant or lactating
* patients with serious medical conditions who, in the opinion of the investigators, should not participate in this study
The control group is represented by patients with the same inclusion and exclusion criteria as the case group, except stress urinary incontinence.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02023502
Study Brief:
Protocol Section:
NCT02023502