An interventional study of herniamesh and biological graft in Pelvic Organ Prolapse, sponsored by Nanjing Medical University. Completed. Open to female participants aged 52 Years to 76 Years. Per ClinicalTrials.gov, last updated 2018-03-08.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Health services research
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.
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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's enrollment of 232 is above the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Nanjing Medical University is the lead sponsor of 171 studies on the registry; 52 are open to participants now.
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242 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;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
accepted herniamesh mesh
Device: herniamesh
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.
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.
recurrence
Recurrence was defined as a POP-quantification system stage ≥IIb or any symptomatic prolapse.
Time frame: at 12 months after surgery
perioperative complications
perioperative complications such as mesh exposure, extrusion , dyspareunia, urinary symptoms(New continence), pain (chronic pelvic pain and hip pain)
Time frame: 12 months after surgery
No study locations are listed for this record.
Ran from Jan 2015 to primary completion in Jun 2016, 17 months.
Of 162 non-industry interventional studies with no phase under Pelvic Organ Prolapse, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 17 months is below that.
Counting every sponsor, half of 179 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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