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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT04348994
Eligibility Criteria:
Inclusion Criteria:
* Adult Female, 18 years of age or older
* Clinical and urodynamic study (UDS) diagnosis of Stress Urinary Incontinence
* No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training
Exclusion Criteria:
* Pre-existing bladder pathology including prior radiation treatment
* Pregnancy
* BMI\>35
* Radical pelvic surgery or previous incontinence surgery
* Urinary tract infection or other active infections of urinary tract or bladder
* SUI III (VLPP \> 60 cm H2O)
* Any form of pelvic organ prolapse (POP) stage 2 or greater, according to POP-Q
* Diagnosis of urge incontinence
* Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
* Incomplete bladder emptying
* Vesicovaginal fistula
* Faecal incontinence
* Unwillingness or inability to complete follow-up schedule
* Unwillingness or inability to give Informed Consent
* Failure to comply with diary requirements during extended baseline period
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04348994
Study Brief:
Protocol Section:
NCT04348994