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

Pelvic Organ Prolapse Clinical Trial

— mesh  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070873
• Other study ID #: NMU-201666
• Status: Completed
• Phase: N/A
• First received: February 15, 2017
• Last updated: February 28, 2017
• Start date: January 1, 2010
• Est. completion date: January 30, 2014

Study information

• Verified date: February 2017
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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。

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: January 30, 2014
• Est. primary completion date: January 30, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Organ Prolapse Quantification	the prolapse of stage II and above is defined as recurrence in POP-Q stage.	at 12 months after surgery
Primary	sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire	PISQ-12	at 12 months after surgery
Primary	pelvic floor distress inventory short form	PFDI-20	at 12 months after surgery
Primary	mesh exposure	mesh was seen in the vagina by gynecological examination	at 12 months after surgery
Primary	sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire	PISQ-12	at 24 months after surgery
Primary	Pelvic Organ Prolapse Quantification	the prolapse of stage II and above is defined as recurrence in POP-Q stage.	at 24 months after surgery
Primary	pelvic floor distress inventory short form	PFDI-20	at 24 months after surgery
Primary	mesh exposure	mesh was seen in the vagina by gynecological examination	at 24 months after surgery
Primary	sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire	PISQ-12	baseline
Primary	pelvic floor distress inventory short form	PFDI-20	baseline
Secondary	stress urinary incontinence	leakage of urine with exertion or with sneezing or coughing	at 1 months after surgery
Secondary	stress urinary incontinence	leakage of urine with exertion or with sneezing or coughing	3 months after surgery
Secondary	Volume of bleeding		during the operation
Secondary	Elevated blood pressure		during the operation
Secondary	Day of postoperative indwelling catheter		1 months after surgery
Secondary	Number of constipation		1 months after surgery