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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02318251
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature
* Stress urinary incontinence (based on the patient's history)
* Mixed incontinence (with dominant SUI)
* 1 year post-partal, parous, nulliparous, pre- or post-menopausal
* BMI 18-30
* Participants must be medically and physically fit for the exercises (running, jumps)
* Stable on systemic or local estrogen treatment for the past 3 months prior to inclusion
Exclusion Criteria:
* Urge incontinence or predominant urgency in incontinence
* Prolapse \> grade 1 POP-Q (Bump et al., 1996) (uterus, cystocele, rectocele during Valsalva maneuver)
* Pregnancy (test to accomplish)
* Current urinary tract or vaginal infection
* Menstruation on the day of examination
* Lactation period not yet finished
* Contraindications for measurements, e.g. acute inflammatory or infectious disease, tumor, fracture
* De novo systemic or local estrogen treatment (\< 3 months)
* De novo drug treatment with anticholinergics or other bladder active substances (tricyclic antidepressants, Selective Serotonin Reuptake Inhibitor etc.)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02318251
Study Brief:
Protocol Section:
NCT02318251