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

NCT03070873 | Completed DMC FDA Device

• 1 other identifier: NMU-201666
• Study Type: interventional
• Target: 258
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse

Keywords

Quality of life; Vaginal mesh; Mesh complications

Outcome Measures

Primary Outcomes (10)

• Pelvic Organ Prolapse Quantification

  the prolapse of stage II and above is defined as recurrence in POP-Q stage.

  at 12 months after surgery

• sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire

  PISQ-12

  at 12 months after surgery

• pelvic floor distress inventory short form

  PFDI-20

  at 12 months after surgery

• mesh exposure

  mesh was seen in the vagina by gynecological examination

  at 12 months after surgery

• sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire

  PISQ-12

  at 24 months after surgery

• Pelvic Organ Prolapse Quantification

  the prolapse of stage II and above is defined as recurrence in POP-Q stage.

  at 24 months after surgery

• pelvic floor distress inventory short form

  PFDI-20

  at 24 months after surgery

• mesh exposure

  mesh was seen in the vagina by gynecological examination

  at 24 months after surgery

• sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire

  PISQ-12

  baseline

• pelvic floor distress inventory short form

  PFDI-20

  baseline

Secondary Outcomes (6)

• stress urinary incontinence

  at 1 months after surgery

• stress urinary incontinence

  3 months after surgery

• Volume of bleeding

  during the operation

• Elevated blood pressure

  during the operation

• Day of postoperative indwelling catheter

  1 months after surgery

Study Arms (3)

group A

EXPERIMENTAL

accepted Perigee and Apogee mesh(PA)

Device: Perigee and Apogee Mesh

group B

EXPERIMENTAL

accepted Gynecare prolift mesh

Device: Gynecare Prolift Mesh

group C

PLACEBO COMPARATOR

Traditional surgery without any mesh

Procedure: Traditional Surgery

Interventions

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.

group A

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.

group B

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.

group C

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu-Fei Shen

  director of Gynecology Department , Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: March 6, 2017
• Study Start: January 1, 2010
• Primary Completion: January 30, 2014
• Study Completion: January 30, 2014
• Last Updated: March 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share