Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse Read More

Inclusion Criteria:

• Candidates with symptomatic pelvic organ prolapse of POP-Q Stage II or more, suitable for surgical repair.
• Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.

Exclusion Criteria:

• Previous repair of pelvic organ prolapse involving insertion of mesh.
• Experimental drug or experimental medical device within 3 months prior to the planned procedure.
• Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
• Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
• History of chemotherapy or pelvic radiation therapy.
• Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
• Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
• Nursing or pregnant or intends future pregnancy.
• Chronic cough not well-controlled.
• BMI ≥ 30.
• In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.