Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01760603
Recruitment Status : Unknown
Verified December 2012 by gwcmc.
Recruitment status was:  Recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Information provided by (Responsible Party):

Brief Summary:

Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue.

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: ISFF Not Applicable

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.

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.
Study Start Date : December 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ISFF
The patients performed ischia spinous fascia fixation surgery.
Procedure: ISFF
Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.

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, postoperative mortality, time of voiding recovery [ Time Frame: At discharge, an expected average of 5 days after operation ]

Other Outcome Measures:
  1. 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

  2. Change from baseline in PFIQ-7 scores [ Time Frame: 6 month, 1 year, 2 years and 3 years ]
  3. n subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) [ Time Frame: 6 months, 1 year, 2 years and 3 years ]
  4. Subject global impression assessed on a 5 point Likert scale [ Time Frame: 6 months, 1 year, 2 years, 3 years ]
  5. 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, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Candidates with symptomatic pelvic organ prolapse of POP-Q Stage II or more, suitable for surgical repair.
  • 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:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01760603

Contact: Lan Zhu 8613911714696
Contact: Juan Chen 8613521354364

China, Guangdong
Foshan Maternal and Child Health Hospital Recruiting
Foshan, Guangdong, China, 528000
Contact: Yuling Wang    8613049161630   
China, Henan
The third Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Luwen Wang    8613607683293   
China, Liaoning
Affiliated Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Zhijun Xia    8613840118800   
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Lan Zhu    13911714696   
Contact: Juan Chen    8613521354364   
Sponsors and Collaborators
Principal Investigator: Lan Zhu gwcmc

Responsible Party: gwcmc Identifier: NCT01760603     History of Changes
Other Study ID Numbers: pumch-gyn-04
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: December 2012

Keywords provided by gwcmc:
pelvic organ prolapse

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