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Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse

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ClinicalTrials.gov Identifier: NCT01760603
Recruitment Status : Unknown
Verified December 2012 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

December 25, 2012
January 4, 2013
January 4, 2013
December 2012
December 2014   (Final data collection date for primary outcome measure)
  • Anatomical improvement according to POP-Q Score [ Time Frame: 6 weeks ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 1 year ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 2 years ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 3 years ]
Same as current
No Changes Posted
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 ]
Same as current
  • 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
  • Change from baseline in PFIQ-7 scores [ Time Frame: 6 month, 1 year, 2 years and 3 years ]
  • 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 ]
  • Subject global impression assessed on a 5 point Likert scale [ Time Frame: 6 months, 1 year, 2 years, 3 years ]
  • 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.
Same as current
 
Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse
A Prospective,Multicenter Pilot Study to Evaluate the Clinical Performance of the Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse.

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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pelvic Organ Prolapse
Procedure: ISFF
Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.
Experimental: ISFF
The patients performed ischia spinous fascia fixation surgery.
Intervention: Procedure: ISFF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
75
Same as current
December 2017
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01760603
pumch-gyn-04
No
Not Provided
Not Provided
Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Principal Investigator: Lan Zhu Peking Union Medical College Hospital
Peking Union Medical College Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP