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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT01123603
Eligibility Criteria:
Inclusion Criteria:
* Patients who are at least 18 years of age,
* Vaginal bleeding secondary to anatomic uterine leiomyomas confirmed at the Cleveland Clinic Fibroid and Menstrual Disorders Center,
* Patients complaining of mass effect symptoms due to fibroids, and
* Patients undergoing either hysterectomy, myomectomy, or uterine artery embolization
Exclusion Criteria:
* Patients who are pregnant, or
* Diagnosis of solitary or multiple intracavitary fibroids without subserosal or intramural leiomyomas present, or
* Prior or interval anti-incontinence procedure, or
* Patients with a urinary tract infection, or
* Patients taking anti-cholinergic medications, or
* Presence of an adnexal mass, or
* Unable or unwilling to complete a follow up survey at six months following treatment
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01123603
Study Brief:
Protocol Section:
NCT01123603