Clinical trial NCT01396122: Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Stage II-III
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2011-07-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anatomical improvement according to POP-Q score.
timeFrame: 4 weeks
measure: Anatomical improvement according to POP-Q score.
timeFrame: 6 months
measure: Anatomical improvement according to POP-Q score.
timeFrame: 12 months
measure: Anatomical improvement according to POP-Q score.
timeFrame: 2 years
measure: Anatomical improvement according to POP-Q score.
timeFrame: 3 years
Secondary outcomes:
measure: Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.
timeFrame: At discharge, an expected average of 5 days after operation.
measure: Pain score measured using Visual Analog Scale (VAS).
timeFrame: 24 hours after surgery and postoperation visit at the 3-4 weeks.
measure: Discomfort of balloon removal, measured using VAS at time of removal.
timeFrame: 24 hours after surgery.
measure: Subject discomfort of VSD by VAS.
timeFrame: postoperation visit at 3-4 weeks.
measure: Presence/absence of complications (composite score)
timeFrame: Up to 6 weeks.
measure: Change from baseline in PFIQ-7 scores.
timeFrame: 6 months, 12 months, 2 years and 3 years.
measure: In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline).
timeFrame: 6 months, 12 months, 2 years and 3 years.
measure: Subject global impression assessed on a 5 point Likert scale.
timeFrame: 6 months, 12 months, 2 years and 3 years.
measure: Presence/absence of complications (composite score)
timeFrame: Up to 3 years.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: Xiamen First Hospital Affiliated to Xiamen University
state: Fujian
city: Foshan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: The First Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: The People's Hospital of Hubei Provincial
state: Hubei
city: Wuhan
country: China
facility: The Third Hospital of Wuhan
state: Hubei
city: Changsha
country: China
facility: The Second Hospital of Xiangya,Central South University
state: Hunan
city: Nanjing
country: China
facility: The First Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Maternal and Child Health Hospital, Nanjing Medical University
state: Jiangsu
city: Shenyang
country: China
facility: Affiliated Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: The Second Affiliated Hospital, Shandong University
state: Shandong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: West China Second Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: The Fifth People' Hospital of Chengdu
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
city: Beijing
country: China
facility: Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences
city: Beijing
country: China
facility: The First Affiliated Hospital of Chinese PLA General Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chongqin
country: China
facility: The First Hospital of Chongqing Medical University
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu
role: PRINCIPAL_INVESTIGATOR
References: