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Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III

Primary Purpose

Pelvic Organ Prolapse

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ischia spinous fascia fixation

Modified Pelvic Floor Reconstruction Surgery with Mesh

polypropylene mesh(Gynemesh)

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Stage III

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Candidates with symptomatic pelvic organ prolapse of POP-Q Stage III, suitable for surgical repair.
Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
Age ≥ 55 years.
Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.

Exclusion Criteria:

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

Foshan Maternal and Child Health HospitalRecruiting
Peking University Shenzhen HospitalRecruiting
the Third Affiliated Hospital of Zhengzhou UniversityRecruiting
Affiliated Shengjing Hospital of China Medical UniversityRecruiting
Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

fascia fixation group

mesh group

Arm Description

procedure: ischia spinous fascia fixation

Procedure: 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

NCT01670682

First Posted

February 22, 2012

Last Updated

August 18, 2012

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01670682

Brief Title

Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III

Official Title

A Prospective，Multicenter Pilot Study to Compare Ischia Spinous Fascia Fixation Procedure With Modified Total Pelvic Floor Reconstruction Surgery For Pelvic Organ Prolapse Stage III

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

August 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 is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh are both developed in China for vaginal apex fixation, the former is native tissue repairs, and the latter is augmentation with mesh. This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh for the treatment of pelvic organ prolapse stage III. 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 (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. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function. Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia fixation procedure with native tissue and modified total pelvic floor reconstructive surgery with mesh. They are both developed and popular in China. Clinical practice showed that they were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1 year follow-up were about 10%, and quality of life improved significantly from the baseline, while the.complications are different. The purpose of this multicenter, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic pelvic organ prolapse Stage III in China.

6. Conditions and Keywords

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

Pelvic Organ Prolapse

Keywords

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

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

fascia fixation group

Arm Type

Active Comparator

Arm Description

procedure: ischia spinous fascia fixation

Arm Title

mesh group

Arm Type

Active Comparator

Arm Description

Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh

Intervention Type

Procedure

Intervention Name(s)

ischia spinous fascia fixation

Intervention Description

Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.

Intervention Type

Procedure

Intervention Name(s)

Modified Pelvic Floor Reconstruction Surgery with Mesh

Intervention Description

Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.

Intervention Type

Device

Intervention Name(s)

polypropylene mesh(Gynemesh)

Intervention Description

Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.

Primary Outcome Measure Information:

Title

•Anatomical improvement according to POP-Q score.

Time Frame

6 weeks

Title

•Anatomical improvement according to POP-Q score.

Time Frame

1 year

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 6-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

1 year, 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

1 year, 2 years and 3 years.

Title

•Subject global impression assessed on a 5 point Likert scale

Time Frame

1 year, 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

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Candidates with symptomatic pelvic organ prolapse of POP-Q Stage III, suitable for surgical repair. Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently. Age ≥ 55 years. Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires. Exclusion Criteria: 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

13911714696

zhu_julie@sina.com

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

Juan Chen

Phone

13521354364

pumchcj@sina.com

Facility Information:

Facility Name

Foshan Maternal and Child Health Hospital

City

Foshan

State/Province

Guangdong

ZIP/Postal Code

528000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuling Wang

Phone

13049161630

Wujun701121@126.com

Facility Name

Peking University Shenzhen Hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518036

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huan Li

Phone

13828700921

szbdlh@163.com

Facility Name

the Third Affiliated 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

Luwen Wang

Phone

13607683293

Wangluwen_688@sohu.com

Facility Name

Affiliated Shengjing Hospital of China Medical University

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110004

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhijun Xia

Phone

13840118800

xiazhijunhosp2@sina.com

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

Juan Chen

Phone

13521354364

pumchcj@sina.com

12. IPD Sharing Statement

Learn more about this trial

Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III

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