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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03186651
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent Form
2. Over the age of 18 years
3. Women diagnosed with stress urinary incontinence
4. Normal voiding without residual urine ≤100mL
5. Leakage of at least 10 grams per 24 hours (based on pad-weight test)
6. Provoking test with leakage
Exclusion Criteria:
1. History of dominated urgency's symptoms
2. Any contraindication for the investigational device; such as hypersensitivity to silicon rubber
3. Unexplained pelvic bleeding or vaginal discharge
4. Is hysterectomized,has a history of incontinent surgery or surgery for prolapse correction.
5. The woman is currently using prolapse ring
6. Women with prolapse reaching the hymus during coughing.
7. Pregnant or suspicion of pregnancy
8. Urinary tract or vaginal infection
9. History of not being able to use tampons
10. Neurogenic bladder dysfunction
11. The patient is to start, or change an ongoing, pelvic floor training
12. If the patient does not have a well adjusted diuretica, or is to start, or change an ongoing, diuretic treatment
13. The patient is participating in another study on SUI
14. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate
15. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03186651
Study Brief:
Protocol Section:
NCT03186651