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Risk Factors for Recurrence After Pelvic Reconstruction

N

Nanjing Medical University

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Device: herniamesh
Device: biological graft

Study type

Interventional

Funder types

Other

Identifiers

NCT03457883
NMU-2017323

Details and patient eligibility

About

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.

Full 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.

Enrollment

232 patients

Sex

Female

Ages

52 to 76 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

232 participants in 2 patient groups

group A
Experimental group
Description:
accepted herniamesh mesh
Treatment:
Device: herniamesh
group B
Experimental group
Description:
accepted biological graft of cook
Treatment:
Device: biological graft

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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