Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-28 @ 3:17 AM
Study NCT ID:
NCT01760603
Status:
UNKNOWN
Last Update Posted:
2013-01-04
First Post:
2012-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: