Risk Factors for Recurrence After Pelvic Reconstruction

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Device: herniamesh; Device: biological graft

• Registration Number: NCT03457883
• Lead Sponsor: Nanjing Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2016-06
• Study Completion: 2017-12
• Status Verified: 2018-02
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-06
• Last Update Submitted: 2018-03-06
• Study First Posted: 2018-03-08
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	herniamesh	accepted herniamesh mesh
group B	biological graft	accepted biological graft of cook

Primary Outcome Measures

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

Secondary Outcome Measures

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