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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03457883

Enrollment

232

Registered

2018-03-08

Start date

2015-01-31

Completion date

2017-12-31

Last updated

2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse, Vaginal mesh, biological graft, Recurrence

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.

Interventions

DEVICEherniamesh

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.

DEVICEbiological 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

52 Years to 76 Years

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026