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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISFF | Experimental | The patients performed ischia spinous fascia fixation surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISFF | Procedure | Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical improvement according to POP-Q Score | 6 weeks | |
| Anatomical improvement according to POP-Q Score | 1 year | |
| Anatomical improvement according to POP-Q Score | 2 years | |
| Anatomical improvement according to POP-Q Score | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital data including operative time, estimated blood loss, length of stay, postoperative mortality, time of voiding recovery | At discharge, an expected average of 5 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Presence/absence of complications (composite score) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhu | Contact | 8613911714696 | zhu_julie@sina.com | |
| Juan Chen | Contact | 8613521354364 | pumchcj@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhu | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foshan Maternal and Child Health Hospital | Recruiting | Foshan | Guangdong | 528000 | China |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Up to 6 weeks |
| Change from baseline in PFIQ-7 scores | 6 month, 1 year, 2 years and 3 years |
| n subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) | 6 months, 1 year, 2 years and 3 years |
| Subject global impression assessed on a 5 point Likert scale | 6 months, 1 year, 2 years, 3 years |
| Presence/absence of complications (composite score) | 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. | up to 3 years |
| The third Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| Affiliated Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110004 | China |
|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
|