Pelvic Organ Prolapse Clinical Trial
Official title:
A Prospective，Multicenter Pilot Study to Compare Ischia Spinous Fascia Fixation Procedure With Modified Total Pelvic Floor Reconstruction Surgery For Pelvic Organ Prolapse Stage III
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous
fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh
are both developed in China for vaginal apex fixation, the former is native tissue repairs,
and the latter is augmentation with mesh.
This study is designed to determine the effectiveness and safety of ischia spinous fascia
fixation procedure compared with modified total pelvic floor reconstructive surgery with
mesh 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.
Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia
fixation procedure with native tissue and modified total pelvic floor reconstructive surgery
with mesh. They are both developed and popular in China. Clinical practice showed that they
were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1
year follow-up were about 10%, and quality of life improved significantly from the baseline,
while the.complications are different.
The purpose of this multicenter, prospective, and comparative study is to evaluate the
effectiveness and safety of these two procedures in the treatment of symptomatic pelvic
organ prolapse Stage III in China.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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