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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fascia fixation group | Active Comparator | procedure: ischia spinous fascia fixation |
|
| mesh group | Active Comparator | Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ischia spinous fascia fixation | Procedure | Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation. |
|
| 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, maximum temperature, time of voiding recovery. | At discharge, an expected average of 5 days after operation. | |
| •Pain score measured using Visual Analog Scale (VAS). | 24 hours post surgery and at the 6-week visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhu | Contact | 13911714696 | zhu_julie@sina.com | |
| Juan Chen | Contact | 13521354364 | pumchcj@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foshan Maternal and Child Health Hospital | Recruiting | Foshan | Guangdong | 528000 | China |
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| Modified Pelvic Floor Reconstruction Surgery with Mesh | Procedure | Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh. |
|
| polypropylene mesh(Gynemesh) | Device | Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene. |
|
| •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. | Up to 6 weeks. |
| •Change from baseline in PFIQ-7 scores. | 1 year, 2 years and 3 years. |
| •In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) | 1 year, 2 years and 3 years. |
| •Subject global impression assessed on a 5 point Likert scale | 1 year, 2 years and 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, mesh erosion, 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. |
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | 518036 | China |
|
| 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 |
|
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009074 | Melanocyte-Stimulating Hormones |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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