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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT06740058
Eligibility Criteria:
Inclusion Criteria:
1. Participant is willing and able to give informed consent for participation in the study.
2. Women aged \> 18 y.o.
3. Women symptomatic for pure or predominant stress incontinence attending the urogynecology outpatient clinic at our institution.
4. Patients undergoing urogynecological standard evaluation for their symptoms, including outpatient gynecological visit and a transvaginal ultrasound.
5. Patients undergoing invasive urodynamic examination for objective assessment of their symptoms or in preparation for possible anti-incontinence surgery.
Exclusion Criteria:
1. Patients with pure or predominant OAB symptomatology
2. Current use of antimuscarinic agents or beta3-agonists (for example Mirabegron)
3. Presence of urological or gynecological cancer.
4. Patients with previous anti-incontinence surgery.
5. Patients with pelvic organ prolapse \> II stage.
6. Patients with chronic bladder retention.
7. Patients with neurological diseases that may affect bladder function and urodynamic results.
8. Participants unwilling or unable to give informed consent for participation in the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06740058
Study Brief:
Protocol Section:
NCT06740058