Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III
A Prospective，Multicenter Pilot Study to Compare Ischia Spinous Fascia Fixation Procedure With Modified Total Pelvic Floor Reconstruction Surgery For Pelvic Organ Prolapse Stage III
1 other identifier
interventional
80
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 22, 2012
August 1, 2012
4 years
February 22, 2012
August 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
•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
Secondary Outcomes (7)
•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
•Presence/absence of complications (composite score).
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.
- +2 more secondary outcomes
Study Arms (2)
fascia fixation group
ACTIVE COMPARATORprocedure: ischia spinous fascia fixation
mesh group
ACTIVE COMPARATORProcedure: Modified Pelvic Floor Reconstruction Surgery with mesh
Interventions
Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.
Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.
Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.
Eligibility Criteria
You may qualify if:
- Candidates with symptomatic pelvic organ prolapse of POP-Q Stage III, suitable for surgical repair.
- 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.
You may not qualify if:
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Foshan Maternal and Child Health Hospital
Foshan, Guangdong, 528000, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
the Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Affiliated Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Peking Union Medical College Hospital
Beijing, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2012
First Posted
August 22, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 22, 2012
Record last verified: 2012-08