Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue. This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure for the treatment of pelvic organ prolapse stage III. Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function. Ischia spinous fascia fixation procedure is developed in China. It is a transvaginal procedure used for restoring the vaginal apex support with native tissue. Clinical practice showed that it was safe, efficient and cost-effective. Recurrent rate after 1 year follow-up was about 10%, and quality of life improved significantly from the baseline. The purpose of this multicenter, prospective study is to evaluate the effectiveness and safety of this procedure in the treatment of symptomatic pelvic organ prolapse.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.
Foshan Maternal and Child Health Hospital
Foshan, Guangdong, China
RECRUITINGThe third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGAffiliated Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGPeking Union Medical College Hospital
Beijing, China
RECRUITINGAnatomical improvement according to POP-Q Score
Time frame: 6 weeks
Anatomical improvement according to POP-Q Score
Time frame: 1 year
Anatomical improvement according to POP-Q Score
Time frame: 2 years
Anatomical improvement according to POP-Q Score
Time frame: 3 years
Hospital data including operative time, estimated blood loss, length of stay, postoperative mortality, time of voiding recovery
Time frame: At discharge, an expected average of 5 days after operation
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