Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01760603
First received: December 25, 2012
Last updated: January 2, 2013
Last verified: December 2012
  Purpose

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 Intervention
Pelvic Organ Prolapse
Procedure: ISFF

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Anatomical improvement according to POP-Q Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Presence/absence of complications (composite score) [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
    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

  • Change from baseline in PFIQ-7 scores [ Time Frame: 6 month, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject global impression assessed on a 5 point Likert scale [ Time Frame: 6 months, 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Presence/absence of complications (composite score) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 75
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760603

Contacts
Contact: Lan Zhu 8613911714696 zhu_julie@sina.com
Contact: Juan Chen 8613521354364 pumchcj@sina.com

Locations
China, Guangdong
Foshan Maternal and Child Health Hospital Recruiting
Foshan, Guangdong, China, 528000
Contact: Yuling Wang    8613049161630    wujun701121@126.com   
China, Henan
The third Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Luwen Wang    8613607683293    wangluwen688@sohu.com   
China, Liaoning
Affiliated Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Zhijun Xia    8613840118800    xiazhijunhosp2@sina.com   
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Lan Zhu    13911714696    zhu_julie@sina.com   
Contact: Juan Chen    8613521354364    pumchcj@sina.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Lan Zhu Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01760603     History of Changes
Other Study ID Numbers: pumch-gyn-04
Study First Received: December 25, 2012
Last Updated: January 2, 2013
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
pelvic organ prolapse

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

ClinicalTrials.gov processed this record on July 28, 2014