Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse
NCT ID: NCT01760603
Last Updated: 2013-01-04
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
75 participants
INTERVENTIONAL
2012-12-31
2017-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ISFF
The patients performed ischia spinous fascia fixation surgery.
ISFF
Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.
Interventions
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ISFF
Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.
Eligibility Criteria
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Inclusion Criteria
* Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
* 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.
18 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Lan Zhu
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Foshan Maternal and Child Health Hospital
Foshan, 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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Other Identifiers
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pumch-gyn-04
Identifier Type: -
Identifier Source: org_study_id
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