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Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III

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ClinicalTrials.gov Identifier: NCT01670682
Recruitment Status : Unknown
Verified August 2012 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Pelvic Organ Prolapse Procedure: ischia spinous fascia fixation Procedure: Modified Pelvic Floor Reconstruction Surgery with Mesh Device: polypropylene mesh(Gynemesh)

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2012
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: fascia fixation group
procedure: ischia spinous fascia fixation
Procedure: ischia spinous fascia fixation
Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.
Active Comparator: mesh group
Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh
Procedure: 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.
Device: polypropylene mesh(Gynemesh)
Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.


Outcome Measures

Primary Outcome Measures :
  1. •Anatomical improvement according to POP-Q score. [ Time Frame: 6 weeks ]
  2. •Anatomical improvement according to POP-Q score. [ Time Frame: 1 year ]
  3. •Anatomical improvement according to POP-Q score. [ Time Frame: 2 years ]
  4. •Anatomical improvement according to POP-Q score. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. •Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery. [ Time Frame: At discharge, an expected average of 5 days after operation. ]
  2. •Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 24 hours post surgery and at the 6-week visit ]
  3. •Presence/absence of complications (composite score). [ Time Frame: Up to 6 weeks. ]
    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.

  4. •Change from baseline in PFIQ-7 scores. [ Time Frame: 1 year, 2 years and 3 years. ]
  5. •In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) [ Time Frame: 1 year, 2 years and 3 years. ]
  6. •Subject global impression assessed on a 5 point Likert scale [ Time Frame: 1 year, 2 years and 3 years. ]
  7. •Presence/absence of complications (composite score) [ Time Frame: Up to 3 years. ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670682


Contacts
Contact: Lan Zhu 13911714696 zhu_julie@sina.com
Contact: Juan Chen 13521354364 pumchcj@sina.com

Locations
China, Guangdong
Foshan Maternal and Child Health Hospital Recruiting
Foshan, Guangdong, China, 528000
Contact: Yuling Wang    13049161630    Wujun701121@126.com   
Peking University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China, 518036
Contact: Huan Li    13828700921    szbdlh@163.com   
China, Henan
the Third Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Luwen Wang    13607683293    Wangluwen_688@sohu.com   
China, Liaoning
Affiliated Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Zhijun Xia    13840118800    xiazhijunhosp2@sina.com   
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Juan Chen    13521354364    pumchcj@sina.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01670682     History of Changes
Other Study ID Numbers: pumch-gyn-03
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by Peking Union Medical College Hospital:
Stage III

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical