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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT03715803
Eligibility Criteria:
Inclusion Criteria:
* Female
* Anterior and apical prolapse Stage 3 (according to POP-Q) or more with or without stress urinary incontinence (SUI)
* Primary or recurrent treatment with Calistar S or Calistar A
* At least 6 months follow-up
Exclusion Criteria:
* Recurrent vaginal infections,
* Chronic colorectal diseases (chronic nonspecific ulcerative colitis, diverticulitis, diverticulosis, Chron's disease, irritable bowel syndrome, familial polyposis).
* Presence of any coagulopathies,
* Impairment of the immune system or any condition that compromises recovery,
* Prior irradiation
* Chronic pelvic pain
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03715803
Study Brief:
Protocol Section:
NCT03715803