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

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ClinicalTrials.gov Identifier: NCT03070873
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Xirong Guo, Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Device: Perigee and Apogee Mesh Device: Gynecare Prolift Mesh Procedure: Traditional Surgery Not Applicable

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。

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
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.
Primary Purpose: Device Feasibility
Official Title: Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : January 30, 2014
Actual Study Completion Date : January 30, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group A
accepted Perigee and Apogee mesh(PA)
Device: Perigee and Apogee Mesh
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.

Experimental: group B
accepted Gynecare prolift mesh
Device: Gynecare Prolift Mesh
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.

Placebo Comparator: group C
Traditional surgery without any mesh
Procedure: Traditional Surgery
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 Measures :
  1. Pelvic Organ Prolapse Quantification [ Time Frame: at 12 months after surgery ]
    the prolapse of stage II and above is defined as recurrence in POP-Q stage.

  2. sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire [ Time Frame: at 12 months after surgery ]
    PISQ-12

  3. pelvic floor distress inventory short form [ Time Frame: at 12 months after surgery ]
    PFDI-20

  4. mesh exposure [ Time Frame: at 12 months after surgery ]
    mesh was seen in the vagina by gynecological examination

  5. sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire [ Time Frame: at 24 months after surgery ]
    PISQ-12

  6. Pelvic Organ Prolapse Quantification [ Time Frame: at 24 months after surgery ]
    the prolapse of stage II and above is defined as recurrence in POP-Q stage.

  7. pelvic floor distress inventory short form [ Time Frame: at 24 months after surgery ]
    PFDI-20

  8. mesh exposure [ Time Frame: at 24 months after surgery ]
    mesh was seen in the vagina by gynecological examination

  9. sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire [ Time Frame: baseline ]
    PISQ-12

  10. pelvic floor distress inventory short form [ Time Frame: baseline ]
    PFDI-20


Secondary Outcome Measures :
  1. stress urinary incontinence [ Time Frame: at 1 months after surgery ]
    leakage of urine with exertion or with sneezing or coughing

  2. stress urinary incontinence [ Time Frame: 3 months after surgery ]
    leakage of urine with exertion or with sneezing or coughing

  3. Volume of bleeding [ Time Frame: during the operation ]
  4. Elevated blood pressure [ Time Frame: during the operation ]
  5. Day of postoperative indwelling catheter [ Time Frame: 1 months after surgery ]
  6. Number of constipation [ Time Frame: 1 months after surgery ]


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070873


Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Director: Yu-Fei Shen director of Gynecology Department , Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
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Responsible Party: Xirong Guo, Vice president of Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03070873    
Other Study ID Numbers: NMU-201666
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Keywords provided by Xirong Guo, Nanjing Medical University:
Quality of life
Vaginal mesh
Mesh complications
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical