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

Pelvic Organ Prolapse Clinical Trial

Official title:

A Prospective, Multicenter Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Symptomatic POP-Q Stage II-III Pelvic Organ Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01396122
• Other study ID #: pumch-gyn-02
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2011
• Last updated: December 25, 2012
• Start date: March 2011
• Est. completion date: March 2016

Study information

• Verified date: July 2011
• Source: Peking Union Medical College Hospital
• Contact: Lan Zhu
• Phone: 86-10-65296238
• Email: zhu_julie[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Stage II-III

Intervention

Procedure:
• Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System
Perform surgery with GYNECARE PROSIMA* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently.

Locations

Country	Name	City	State
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 Affiliated Hospital of Chinese PLA General Hospital	Beijing
China	The Second Hospital of Xiangya,Central South University	Changsha	Hunan
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	The First Hospital of Chongqing Medical University	Chongqin
China	The First People's Hospital of Foshan	Foshan	Guangdong
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong
China	The First Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated Hospital, Shandong University	Jinan	Shandong
China	Mianyang Central Hospital	Mianyang	Sichuan
China	The First Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Affiliated Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	The People's Hospital of Hubei Provincial	Wuhan	Hubei
China	The Third Hospital of Wuhan	Wuhan	Hubei
China	Wuxi Maternal and Child Health Hospital, Nanjing Medical University	Wuxi	Jiangsu
China	Xiamen First Hospital Affiliated to Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical improvement according to POP-Q score.		4 weeks	No
Primary	Anatomical improvement according to POP-Q score.		6 months	No
Primary	Anatomical improvement according to POP-Q score.		12 months	No
Primary	Anatomical improvement according to POP-Q score.		2 years	No
Primary	Anatomical improvement according to POP-Q score.		3 years	No
Secondary	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.	Yes
Secondary	Pain score measured using Visual Analog Scale (VAS).		24 hours after surgery and postoperation visit at the 3-4 weeks.	Yes
Secondary	Discomfort of balloon removal, measured using VAS at time of removal.		24 hours after surgery.	Yes
Secondary	Subject discomfort of VSD by VAS.		postoperation visit at 3-4 weeks.	Yes
Secondary	Presence/absence of complications (composite score)	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.	Up to 6 weeks.	Yes
Secondary	Change from baseline in PFIQ-7 scores.		6 months, 12 months, 2 years and 3 years.	No
Secondary	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.	No
Secondary	Subject global impression assessed on a 5 point Likert scale.		6 months, 12 months, 2 years and 3 years.	No
Secondary	Presence/absence of complications (composite score)	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.	Up to 3 years.	Yes