Clinical Trial: Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Peking Union Medical College Hospital

Current Primary Outcome:

  • Anatomical 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: December 25, 2012
Date Started: December 2012
Date Completion: December 2017
Last Updated: January 2, 2013
Last Verified: December 2012