Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.|
- Anatomical improvement according to POP-Q Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Anatomical improvement according to POP-Q Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Anatomical improvement according to POP-Q Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Anatomical improvement according to POP-Q Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Presence/absence of complications (composite score) [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]The occurrence (in the per-operative phase or within 6 weeks post-op) of at least one of the following: 1) bleeding complications; 2) infectious complications; 3) any wound caused by a surgeon movement: bladder, ureteral, or vascular injuries; 4)medical complications: deep vein thrombosis, pulmonary embolism and etc.Complications will be categorized using the Dindo surgical complication grading scale
- Change from baseline in PFIQ-7 scores [ Time Frame: 6 month, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]
- n subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) [ Time Frame: 6 months, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]
- Subject global impression assessed on a 5 point Likert scale [ Time Frame: 6 months, 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]
- Presence/absence of complications (composite score) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]Long-term negative outcomes of the surgical procedure will also be recorded until 3 years after surgery. For example, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
The patients performed ischia spinous fascia fixation surgery.
Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760603
|Contact: Lan Zhufirstname.lastname@example.org|
|Contact: Juan Chenemail@example.com|
|Foshan Maternal and Child Health Hospital||Recruiting|
|Foshan, Guangdong, China, 528000|
|Contact: Yuling Wang 8613049161630 firstname.lastname@example.org|
|The third Affiliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Luwen Wang 8613607683293 email@example.com|
|Affiliated Shengjing Hospital of China Medical University||Recruiting|
|Shenyang, Liaoning, China, 110004|
|Contact: Zhijun Xia 8613840118800 firstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, China, 100730|
|Contact: Lan Zhu 13911714696 email@example.com|
|Contact: Juan Chen 8613521354364 firstname.lastname@example.org|
|Principal Investigator:||Lan Zhu||Peking Union Medical College Hospital|