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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT06418451
Eligibility Criteria:
Inclusion Criteria:
* Patients with symptomatic mid-pelvic organ prolapse (POP-Q stage ≥ II) who may concurrently have anterior and/or posterior pelvic organ prolapse.
* Patients willing to undergo long-term follow-up for at least one year.
* Patients willing to sign an informed consent form and participate in this study.
Exclusion Criteria:
* Patients who have undergone previous POP or urinary incontinence surgery with the use of implant materials.
* Patients who require simultaneous anti-urinary incontinence surgery for the current procedure.
* Contraindications for general anesthesia and surgical intervention, such as severe medical comorbidities that render the patient unable to tolerate surgery.
* Patients who wish to preserve the uterus.
* Patients in the active phase of genital, urinary, or systemic infections.
* Patients who, for other reasons (such as having genital malignancies), choose not to undergo SSLF/modified ISFF surgical intervention at the moment.
* Patients who are unable or unwilling to attend follow-up visits (excluding those who may be willing to participate in telephone follow-up).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06418451
Study Brief:
Protocol Section:
NCT06418451