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Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift (mesh)

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perigee and Apogee Mesh
Gynecare Prolift Mesh
Traditional Surgery
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pelvic Organ Prolapse focused on measuring Quality of life, Vaginal mesh, Mesh complications

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with stage III ~ IV degree of anterior and posterior vaginal wall prolapse and uterine prolapse (total pelvic floor prolapse) by the Pelvic Organ Prolapse Quantification System (POP-Q) were included

Exclusion Criteria:

  • Simple anterior or posterior wall prolapse, simple uterine prolapse, combined with stress urinary incontinence, overactive bladder (OAB), pelvic floor repair surgery history and recurrent patients
  • Local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position)
  • Vaginal bleeding;coagulation disorders
  • Infection,or uncontrolled hypertension and diabetes mellitus
  • Pelvic cancer and radiation to the pelvic area in the previous 6 months.
  • Also women of reproductive age, and planning of pregnancy were also excluded for mesh usage.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    group A

    group B

    group C

    Arm Description

    accepted Perigee and Apogee mesh(PA)

    accepted Gynecare prolift mesh

    Traditional surgery without any mesh

    Outcomes

    Primary Outcome Measures

    Pelvic Organ Prolapse Quantification
    the prolapse of stage II and above is defined as recurrence in POP-Q stage.
    sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
    PISQ-12
    pelvic floor distress inventory short form
    PFDI-20
    mesh exposure
    mesh was seen in the vagina by gynecological examination
    sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
    PISQ-12
    Pelvic Organ Prolapse Quantification
    the prolapse of stage II and above is defined as recurrence in POP-Q stage.
    pelvic floor distress inventory short form
    PFDI-20
    mesh exposure
    mesh was seen in the vagina by gynecological examination
    sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
    PISQ-12
    pelvic floor distress inventory short form
    PFDI-20

    Secondary Outcome Measures

    stress urinary incontinence
    leakage of urine with exertion or with sneezing or coughing
    stress urinary incontinence
    leakage of urine with exertion or with sneezing or coughing
    Volume of bleeding
    Elevated blood pressure
    Day of postoperative indwelling catheter
    Number of constipation

    Full Information

    First Posted
    February 15, 2017
    Last Updated
    February 28, 2017
    Sponsor
    Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03070873
    Brief Title
    Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
    Acronym
    mesh
    Official Title
    Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    January 30, 2014 (Actual)
    Study Completion Date
    January 30, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery, and also studied the influence of some surgical procedures on the prognosis.
    Detailed Description
    Pelvic organ prolapse is defined as a downward descent of the pelvic organs that results in the protrusion of vagina, uterus, or both. The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery. The investigators also studied the influence of some surgical procedures on the prognosis. In this study，The investigators divided the patients randomly into three groups :the group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)；the group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh；the group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.The investigators did POP-Q measurements and questionnaire preoperatively and postoperatively and recorded volume of bleeding，day of postoperative indwelling catheter and the mesh complications。

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse
    Keywords
    Quality of life, Vaginal mesh, Mesh complications

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The investigators divided the patients randomly into three groups: The group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)； The group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh； The group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.
    Masking
    ParticipantInvestigator
    Masking Description
    In the study the operation was performed by three surgeons, the patients received surgery by the doctor when the patients saw in the outpatient clinic.
    Allocation
    Randomized
    Enrollment
    258 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Experimental
    Arm Description
    accepted Perigee and Apogee mesh(PA)
    Arm Title
    group B
    Arm Type
    Experimental
    Arm Description
    accepted Gynecare prolift mesh
    Arm Title
    group C
    Arm Type
    Placebo Comparator
    Arm Description
    Traditional surgery without any mesh
    Intervention Type
    Device
    Intervention Name(s)
    Perigee and Apogee Mesh
    Intervention Description
    The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
    Intervention Type
    Device
    Intervention Name(s)
    Gynecare Prolift Mesh
    Intervention Description
    The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
    Intervention Type
    Procedure
    Intervention Name(s)
    Traditional Surgery
    Intervention Description
    The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
    Primary Outcome Measure Information:
    Title
    Pelvic Organ Prolapse Quantification
    Description
    the prolapse of stage II and above is defined as recurrence in POP-Q stage.
    Time Frame
    at 12 months after surgery
    Title
    sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
    Description
    PISQ-12
    Time Frame
    at 12 months after surgery
    Title
    pelvic floor distress inventory short form
    Description
    PFDI-20
    Time Frame
    at 12 months after surgery
    Title
    mesh exposure
    Description
    mesh was seen in the vagina by gynecological examination
    Time Frame
    at 12 months after surgery
    Title
    sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
    Description
    PISQ-12
    Time Frame
    at 24 months after surgery
    Title
    Pelvic Organ Prolapse Quantification
    Description
    the prolapse of stage II and above is defined as recurrence in POP-Q stage.
    Time Frame
    at 24 months after surgery
    Title
    pelvic floor distress inventory short form
    Description
    PFDI-20
    Time Frame
    at 24 months after surgery
    Title
    mesh exposure
    Description
    mesh was seen in the vagina by gynecological examination
    Time Frame
    at 24 months after surgery
    Title
    sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
    Description
    PISQ-12
    Time Frame
    baseline
    Title
    pelvic floor distress inventory short form
    Description
    PFDI-20
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    stress urinary incontinence
    Description
    leakage of urine with exertion or with sneezing or coughing
    Time Frame
    at 1 months after surgery
    Title
    stress urinary incontinence
    Description
    leakage of urine with exertion or with sneezing or coughing
    Time Frame
    3 months after surgery
    Title
    Volume of bleeding
    Time Frame
    during the operation
    Title
    Elevated blood pressure
    Time Frame
    during the operation
    Title
    Day of postoperative indwelling catheter
    Time Frame
    1 months after surgery
    Title
    Number of constipation
    Time Frame
    1 months after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with stage III ~ IV degree of anterior and posterior vaginal wall prolapse and uterine prolapse (total pelvic floor prolapse) by the Pelvic Organ Prolapse Quantification System (POP-Q) were included Exclusion Criteria: Simple anterior or posterior wall prolapse, simple uterine prolapse, combined with stress urinary incontinence, overactive bladder (OAB), pelvic floor repair surgery history and recurrent patients Local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position) Vaginal bleeding;coagulation disorders Infection,or uncontrolled hypertension and diabetes mellitus Pelvic cancer and radiation to the pelvic area in the previous 6 months. Also women of reproductive age, and planning of pregnancy were also excluded for mesh usage.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu-Fei Shen
    Organizational Affiliation
    director of Gynecology Department , Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift

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