Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse

Not Applicable

• Conditions: Pelvic Organ Prolapse; Stage II-III

• Registration Number: NCT01396122
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA\* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse.

Detailed Description

The GYNECARE PROSIMA\* system is a new technique and now available in China. It provides a simplified unanchored mesh repair, making surgery much simpler to perform and reduces the risk of the specific complications that may occur when tunneling devices beyond the pelvic cavity.

In clinical practice, many women have symptomatic prolapse, which requires surgical correction. They are relatively young, and therefore care more about the long-term outcomes and quality of life after procedure. The purpose of this multicenter and prospective study is to evaluate the effectiveness and safety of the GYNECARE PROSIMA\* system in the treatment of symptomatic POP-Q Stage II-III pelvic organ prolapse.

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-07
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-18
• Last Update Submitted: 2012-12-25
• Last Update Posted: 2012-12-27
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy and mid-urethral sling procedures for incontinence may be performed concurrently.
• Age ≥ 18 years.
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent.

Exclusion Criteria

• Additional surgical intervention concurrent to the procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
• Previous repair of pelvic organ prolapse involving insertion of mesh.
• Previous hysterectomy within 6 months of scheduled surgery.
• 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: SINGLE_GROUP

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 after surgery and postoperation visit at the 3-4 weeks.
Discomfort of balloon removal, measured using VAS at time of removal.	24 hours after surgery.
Subject discomfort of VSD by VAS.	postoperation visit at 3-4 weeks.
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.
Change from baseline in PFIQ-7 scores.	6 months, 12 months, 2 years and 3 years.
In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline).	6 months, 12 months, 2 years and 3 years.
Subject global impression assessed on a 5 point Likert scale.	6 months, 12 months, 2 years and 3 years.

Trial Locations

Locations (25)

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

The People's Hospital of Hubei Provincial; 🇨🇳 Wuhan, Hubei, China

The First Hospital Affiliated to Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The First People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

Xiamen First Hospital Affiliated to Xiamen University; 🇨🇳 Xiamen, Fujian, China

The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China

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

The First Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The Second Hospital of Xiangya,Central South University; 🇨🇳 Changsha, Hunan, China

The Third Hospital of Wuhan; 🇨🇳 Wuhan, Hubei, China

The Second Affiliated Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Wuxi Maternal and Child Health Hospital, Nanjing Medical University; 🇨🇳 Wuxi, Jiangsu, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China

The Fifth People' Hospital of Chengdu; 🇨🇳 Chengdu, Sichuan, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

West China Second Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Mianyang Central Hospital; 🇨🇳 Mianyang, Sichuan, China

The First Affiliated Hospital of Chinese PLA General Hospital; 🇨🇳 Beijing, China

Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences; 🇨🇳 Beijing, China

Beijing Hospital; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

The First Hospital of Chongqing Medical University; 🇨🇳 Chongqin, China