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GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III

Primary Purpose

Uterine Prolapse, Stage III

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System

Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh

About this trial

This is an interventional treatment trial for Uterine Prolapse

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Candidates with symptomatic uterine prolapse of ICS POP-Q Stage III(with any degree of vaginal prolapse), suitable for surgical repair.
Vaginal hysterectomy will be performed concurrently.
Without stress urinary incontinence or occult stress urinary incontinence with no need of mid-urethral sling procedures for incontinence to be performed.
Age ≥ 60 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 / IRB 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.
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.

Sites / Locations

Hefei Maternity and Child Health Hospital
Gansu Maternity and Child Health HospitalRecruiting
Hebei Provincial Hospital
the First Affliliated Hospital of Zhengzhou UniversityRecruiting
Wuxi Maternal and Child Health Hospital, Nanjing Medical UniversityRecruiting
Maternal and Child Health Hospital of Jiangxi Province
Laizhou Municipal People's HospitalRecruiting
Women's Hospital School of Medicine Zhejiang UniversityRecruiting
Peking University Third HospitalRecruiting
Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group I

Group II

Arm Description

Intervention: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System

Intervention: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with Mesh

Outcomes

Primary Outcome Measures

Anatomical improvement according to POP-Q score.

Secondary Outcome Measures

Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.

Pain score measured using Visual Analog Scale (VAS).

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.

Change from baseline in PFIQ-7 scores.

In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)

Subject global impression assessed on a 5 point Likert scale

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.

Full Information

NCT ID

NCT01396109

First Posted

July 13, 2011

Last Updated

December 25, 2012

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01396109

Brief Title

GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III

Official Title

A Prospective, Multicenter Trial to Compare GYNECARE PROSIMA* Pelvic Floor Repair System Procedure With Modified Total Pelvic Floor Reconstruction Surgery Concomitantly With TVH to Treat Symptomatic POP-Q Stage III Uterine Prolapse

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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. The primary treatment is surgery, sometimes a mesh is placed in the pelvis to support the weakened tissues, but mesh implants can cause complications. This study is designed to determine the effectiveness and safety of GYNECARE PROSIMA* pelvic floor repair system compared with the modified total pelvic floor reconstructive surgery with mesh for the treatment of uterine prolapse. 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 is a common problem. The high rate of failure has led to an increasing use of synthetic grafts to augment vaginal repair procedures to obtain more durable results. In 2005, the investigators began to perform modified pelvic floor reconstruction surgery with mesh. The nation-wide multicenter prospective clinical trial data showed that it was safe, efficient and cost-effective. No severe intraoperative complications were recorded and the recurrence rate after 1 year follow-up was 8.1%. Quality of life improved significantly from the baseline, while the sexual function did not change. The GYNECARE PROSIMA* system is a new technique. It provides a simplified unanchored mesh repair, avoiding the need for dissection outside the pelvic cavity and avoids passage of suture and instruments through the obturator foramen and sacrospinous ligament, thus making surgery much simpler to perform and reduces the risk of the specific complications that can occur with suture placement or tunneling. 1-year anatomic and functional outcomes of international multicenter prospective study for POP-Q Stage I I-III pelvic organ prolapse showed the objective success rate was 76.9%, pelvic symptoms, quality of life, and sexual function improved significantly from baseline. In clinical practice, many women have symptomatic POP-Q Stage III uterine 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, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures concomitantly performed with vaginal hysterectomy (TVH) in the treatment of symptomatic POP-Q Stage III uterine prolapse in China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Prolapse, Stage III

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Active Comparator

Arm Description

Intervention: Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System

Arm Title

Group II

Arm Type

Active Comparator

Arm Description

Intervention: Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with Mesh

Intervention Type

Procedure

Intervention Name(s)

Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System

Intervention Description

Subjects of this group were submitted to surgical treatment with GYNECARE PROSIMA* Pelvic Floor Repair System concurrently with transvaginal hysterectomy.

Intervention Type

Procedure

Intervention Name(s)

Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh

Intervention Description

Subjects of this group were submitted to surgical treatment of Modified Pelvic Floor Reconstruction Surgery with mesh concurrently with transvaginal hysterectomy.

Primary Outcome Measure Information:

Title

Anatomical improvement according to POP-Q score.

Time Frame

4 weeks

Title

Anatomical improvement according to POP-Q score.

Time Frame

6 months

Title

Anatomical improvement according to POP-Q score.

Time Frame

12 months

Title

Anatomical improvement according to POP-Q score.

Time Frame

2 years

Title

Anatomical improvement according to POP-Q score.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.

Time Frame

At discharge, an expected average of 5 days after operation.

Title

Pain score measured using Visual Analog Scale (VAS).

Time Frame

24 hours post surgery and at the 3-4 week visit

Title

Presence/absence of complications (composite score).

Description

Time Frame

Up to 6 weeks.

Title

Change from baseline in PFIQ-7 scores.

Time Frame

6 months, 12 months, 2 years and 3 years.

Title

In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)

Time Frame

6 months, 12 months, 2 years and 3 years.

Title

Subject global impression assessed on a 5 point Likert scale

Time Frame

6 months, 12 months, 2 years and 3 years.

Title

Presence/absence of complications (composite score)

Description

Time Frame

Up to 3 years.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Candidates with symptomatic uterine prolapse of ICS POP-Q Stage III(with any degree of vaginal prolapse), suitable for surgical repair. Vaginal hysterectomy will be performed concurrently. Without stress urinary incontinence or occult stress urinary incontinence with no need of mid-urethral sling procedures for incontinence to be performed. Age ≥ 60 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 / IRB 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lan Zhu

Phone

86-10-65296238

zhu_julie@vip.sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Juan Chen

Phone

86-13521354364

pumchcj@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lan Zhu

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hefei Maternity and Child Health Hospital

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230001

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Gansu Maternity and Child Health Hospital

City

Lanzhou

State/Province

Gansu

ZIP/Postal Code

730050

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qing Liu

gslzlq@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Qing Liu

Facility Name

Hebei Provincial Hospital

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050051

Country

China

Individual Site Status

Active, not recruiting

Facility Name

the First Affliliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mei Ji

Jimei0821@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Mei Ji

Facility Name

Wuxi Maternal and Child Health Hospital, Nanjing Medical University

City

Wuxi

State/Province

Jiangsu

ZIP/Postal Code

214002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Gong

gongjianwx@126.com

First Name & Middle Initial & Last Name & Degree

Jian Gong

Facility Name

Maternal and Child Health Hospital of Jiangxi Province

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Individual Site Status

Active, not recruiting

Facility Name

Laizhou Municipal People's Hospital

City

Laizhou

State/Province

Shandong

ZIP/Postal Code

261400

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie-liang Li

lzlijieliang@126.com

First Name & Middle Initial & Last Name & Degree

Jie-liang Li

Facility Name

Women's Hospital School of Medicine Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hangmei Jin

jinhm@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Hang-mei Jin

Facility Name

Peking University Third Hospital

City

Beijing

ZIP/Postal Code

100191

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin-song Han

Hanjinsong353@sina.com

First Name & Middle Initial & Last Name & Degree

Jin-song Han

Facility Name

Peking Union Medical College Hospital

City

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lan Zhu

Phone

86-10-65296238

zhu_julie@vip.sina.com

First Name & Middle Initial & Last Name & Degree

Juan Chen

Phone

86-13521354364

pumchcj@sina.com

First Name & Middle Initial & Last Name & Degree

Lan Zhu

12. IPD Sharing Statement

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GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III

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