Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III
NCT ID: NCT01670682
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2012-08-31
2016-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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fascia fixation group
procedure: ischia spinous fascia fixation
ischia spinous fascia fixation
Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.
mesh group
Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh
Modified Pelvic Floor Reconstruction Surgery with Mesh
Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.
polypropylene mesh(Gynemesh)
Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.
Interventions
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ischia spinous fascia fixation
Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.
Modified Pelvic Floor Reconstruction Surgery with Mesh
Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.
polypropylene mesh(Gynemesh)
Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.
Eligibility Criteria
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Inclusion Criteria
* Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
* Age ≥ 55 years.
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
Exclusion Criteria
* Experimental drug or experimental medical device within 3 months prior to the planned procedure.
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
* History of chemotherapy or pelvic radiation therapy.
* Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
* Nursing or pregnant or intends future pregnancy.
* Chronic cough not well-controlled.
* BMI ≥ 30.
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
55 Years
80 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Foshan Maternal and Child Health Hospital
Foshan, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
the Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Affiliated Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Yuling Wang
Role: primary
Huan Li
Role: primary
Luwen Wang
Role: primary
Zhijun Xia
Role: primary
Juan Chen
Role: primary
Other Identifiers
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pumch-gyn-03
Identifier Type: -
Identifier Source: org_study_id