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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT05760794
Eligibility Criteria:
Inclusion Criteria:
* Age ≥21
* Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen
* Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher
* Eligible for laparoscopic or robotic sacrocolpopexy
* Desires surgical treatment for symptomatic uterovaginal or vaginal vault prolapse
* English speaking
Exclusion Criteria:
* Patients who are not surgical candidates due to medical comorbidities
* Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
* Inability to give informed consent or to complete the testing or data collection.
* Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc.).
* Active systemic infection including any gynecologic infection, untreated Urinary Tract Infection (UTI) or tissue necrosis.
* History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
* Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
* Subject has taken systemic steroids (within the last month, steroid inhalers OK), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
* Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatic, lupus)
* Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
* Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c \> 9
* Those requiring concomitant rectopexy
* Subject is not able to conform to steep Trendelenburg position
* Known sensitivity to polypropylene
* History of prior prolapse repair utilizing vaginal or abdominal mesh
* Planned vaginal mesh attachment placed transvaginally
* History of diverticulitis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT05760794
Study Brief:
Protocol Section:
NCT05760794