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

NCT01396122 | Unknown

• 1 other identifier: pumch-gyn-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 25

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.

Conditions

Pelvic Organ Prolapse; Stage II-III

Outcome Measures

Primary Outcomes (5)

• Anatomical improvement according to POP-Q score.

  4 weeks

• Anatomical improvement according to POP-Q score.

  6 months

• Anatomical improvement according to POP-Q score.

  12 months

• Anatomical improvement according to POP-Q score.

  2 years

• Anatomical improvement according to POP-Q score.

  3 years

Secondary Outcomes (9)

• 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 6 weeks.

Study Arms (1)

PROSIMA group

EXPERIMENTAL

Reconstructive surgeries with GYNECARE PROSIMA\* were performed in all patients.

Procedure: Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System

Interventions

Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System PROCEDURE

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

PROSIMA group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (25)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

ACTIVE NOT RECRUITING

Xiamen First Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361004, China

RECRUITING

The First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

NOT YET RECRUITING

The First Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

ACTIVE NOT RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

ACTIVE NOT RECRUITING

The People's Hospital of Hubei Provincial

Wuhan, Hubei, 430060, China

ACTIVE NOT RECRUITING

The Third Hospital of Wuhan

Wuhan, Hubei, 430060, China

ACTIVE NOT RECRUITING

The Second Hospital of Xiangya,Central South University

Changsha, Hunan, 410011, China

RECRUITING

The First Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, 210006, China

ACTIVE NOT RECRUITING

Wuxi Maternal and Child Health Hospital, Nanjing Medical University

Wuxi, Jiangsu, 214002, China

RECRUITING

Affiliated Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

The Second Affiliated Hospital, Shandong University

Jinan, Shandong, 250033, China

ACTIVE NOT RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

West China Second Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

ACTIVE NOT RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

ACTIVE NOT RECRUITING

The Fifth People' Hospital of Chengdu

Chengdu, Sichuan, 611130, China

ACTIVE NOT RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

RECRUITING

Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences

Beijing, 100020, China

RECRUITING

The First Affiliated Hospital of Chinese PLA General Hospital

Beijing, 100048, China

RECRUITING

Beijing Hospital

Beijing, 100730, China

ACTIVE NOT RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

The First Hospital of Chongqing Medical University

Chongqin, 400016, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lan Zhu

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Zhu

CONTACT

86-10-65296238; zhu_julie@vip.sina.com

Juan Chen

CONTACT

86-13521354364; pumchcj@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 18, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 27, 2012

Record last verified: 2011-07

Locations

CN (25)