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Completed

NCT Number: NCT03070873

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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。

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perigee and Apogee Mesh

Device

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.

Gynecare Prolift Mesh

Device

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.

Traditional Surgery

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Acronym: mesh

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2017
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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