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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01559168
Eligibility Criteria:
Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* Patients with symptoms and altered quality of life in relation to uterine or post-hysterectomy vault prolapse
* Patients who are receiving the UpholdTM LITE mesh Kit
* Female patients \>= years who have no desire of future pregnancy
* Diagnosed with pelvic organ prolapse and \>= ICS POP-Q Stage 2 Symptomatic Prolapse apical compartment (uterine or vault), associated with ICS POP-Q Stage 2 or 3 Symptomatic Prolapse anterior compartment (point Ba \>= -1
* Patients willing to complete quality of life questionnaire at baseline (pre-procedure) and at 6 weeks, 6 and 12 months post-procedure
Exclusion Criteria:
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Patients who are not receiving the UpHoldTM LITE mesh Kit
* Patients \< 50 years
* Patients qho, according to the clinical judgment of the investigator, are not suitable for this study
* Patients who are considering future pregnancies
* Patients whose pelvic organ prolapse is a \<= 1 ICS Stage
* Patients requiring Posterior Graft procedure
* Patients with known or suspected hypersensitivity to polypropylene
* Patients with any pathology which ould compromise implant placement
* Patients with any pathology which ould compromise implant placement as mentioned in the device instruction manual
* Patients with any pathology that would limit blood supply and compromise healing
* Patients with blood coagulation disorder (associated current level coagulation)
* Patients with autoimmune connective tissue disease
* Patients with upper urinary tract obstruction and renal insufficiency
* Patients with local or systemic infection
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT01559168
Study Brief:
Protocol Section:
NCT01559168