Risk Factors for Recurrence After Pelvic Reconstruction

Risk Factors for Recurrence After Pelvic Reconstruction of Pelvic Organ Prolapse：1 Year Follow-up in Patients Implanted Hernia Mesh and Biological Graft

232 women underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, including group A（accepted herniamesh polypropylene mesh， 117 patients)；group B （underwent biological graft of cook，115 patients)；follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: herniamesh; Device: biological graft

Detailed Description

We prospectively study a total of 232 women who underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for symptomatic POP, the patients into two groups :group A was accepted herniamesh polypropylene mesh(117)；group B underwent biological graft of cook(115)；Each patient underwent an interview that included a POP-Q which was quantified according to the Pelvic Organ Prolapse Quantitation (POPQ) system;follow-ups for six months and one year after the surgery and a questionnaire about the life habits associated with relapse.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 52 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

242 postmenopausal patients with primary prolapse of the anterior vaginal wall or concomitant uterine prolapse,that was stage Ⅲ or higher (according to the Pelvic Organ Prolapse Quantification [POP-Q] system).

Exclusion Criteria:

pelvic floor repair surgery history and recurrent patients ; pelvic cancer and radiation to the pelvic area in the previous 6 months; simple uterine prolapse; combined with severe stress urinary incontinence or overactive bladder (OAB); 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; infection; coagulation disorders; uncontrolled hypertension and diabetes mellitus;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; accepted herniamesh mesh	Device: herniamesh; Patients were randomly assigned in a ratio of 1:1,by using SPSS19.0 statistical software, to either trocar-guided transvaginal mesh(herniamesh, group A) or biological graft (cook, group B)repair.
Experimental: group B; accepted biological graft of cook	Device: biological graft; Patients were randomly assigned in a ratio of 1:1,by using SPSS19.0 statistical software, to either trocar-guided transvaginal mesh(herniamesh, group A) or biological graft (cook, group B)repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence	Recurrence was defined as a POP-quantification system stage ≥IIb or any symptomatic prolapse.	at 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative complications	perioperative complications such as mesh exposure, extrusion , dyspareunia, urinary symptoms(New continence), pain (chronic pelvic pain and hip pain)	12 months after surgery

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Recurrence; Pelvic organ prolapse; biological graft; Vaginal mesh
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Recurrence; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: NMU-2017323

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No