herniamesh
DevicePatients 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.
NCT Number: NCT03457883
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.
Looking for future studies?
Notify Me52 year–76 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
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.
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.
Time frame: at 12 months after surgery
Recurrence was defined as a POP-quantification system stage ≥IIb or any symptomatic prolapse.
Time frame: 12 months after surgery
perioperative complications such as mesh exposure, extrusion , dyspareunia, urinary symptoms(New continence), pain (chronic pelvic pain and hip pain)
Nanjing Medical University
Other
Risk Factors for Recurrence After Pelvic Reconstruction of Pelvic Organ Prolapse:1 Year Follow-up in Patients Implanted Hernia Mesh and Biological Graft
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06744972
Cystocele, Disease Attributes
View Trial DetailsNCT00372190
Disease Attributes, Pathologic Processes
Apeldoorn, Netherlands
View Trial DetailsNCT02890498
Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms
Nîmes, France
View Trial DetailsNCT06532292
Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms
Taipei, Taiwan
View Trial Details