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

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: ischia spinous fascia fixation; Procedure: Modified Pelvic Floor Reconstruction Surgery with Mesh; Device: polypropylene mesh(Gynemesh)

• Registration Number: NCT01670682
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 Timeline

• Study First Submitted: 2012-02-22
• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-18
• Last Update Submitted: 2012-08-18
• Study First Posted: 2012-08-22
• Last Update Posted: 2012-08-22
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fascia fixation group	ischia spinous fascia fixation	procedure: ischia spinous fascia fixation
mesh group	Modified Pelvic Floor Reconstruction Surgery with Mesh	Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh
mesh group	polypropylene mesh(Gynemesh)	Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh

Primary Outcome Measures

Name	Time	Method
•Anatomical improvement according to POP-Q score.	3 years

Secondary Outcome Measures

Name	Time	Method
•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.	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.	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.
•Subject global impression assessed on a 5 point Likert scale	1 year, 2 years and 3 years.
•Presence/absence of complications (composite score)	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.

Trial Locations

Locations (5)

the Third Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Foshan Maternal and Child Health Hospital; 🇨🇳 Foshan, Guangdong, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Affiliated Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China