Clinical Trial

POPQ Associated With Total Laparoscopic Hysterectomy

Study acronym: POP-LAP
Not Yet Recruiting
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Summary
The goal of this observational study is to evaluate the impact of different hysterectomy (removal of the uterus) techniques on the risk of pelvic organ prolapse (situation when one or more of your pelvic organs like your bladder, uterus, or rectum have dropped down or slipped out of their normal position, sometimes even bulging into the vagina) and urinary incontinence (leaking urine unexpectedly) in women aged 18-85 who underwent hysterectomy or supracervical hysterectomy (removing of the uterus without its cervix) for benign (not cancer) conditions. The main question is: to check how different surgical technique (laparoscopic, with opening the abdomen, vaginal and robotic) increase the risk of pelvic organ prolapse or urinary incontinence There is no randomization or control group; comparisons will be made between surgery types based on clinical and questionnaire data. Participants will: * Receive an invitation to participate if they underwent hysterectomy between 2021-2025. * Fill out validated quality of life questionnaires (P-QOL, POPDI-6, PFIQ-7) every two years. * Attend follow-up clinical pelvic exams every two years to assess vaginal cuff healing, pelvic organ prolapses (POP-Q system), and urinary symptoms. This prospective, non-commercial, multicenter study plans to enroll 2,000 women and will run from July 1, 2025, to July 1, 2036
Trial Details
NCT Number NCT07137299
Lead Sponsor Medical University of Silesia
Collaborators: St. Boniface Hospital, Klinika Ginekologii i Ginekologii Onkologicznej CMKP, I Klinika Położnictwa i Ginekologii, Wydział Lekarski Warszawski Uniwersytet Medyczny
Conditions Uterine Fibroids (UF), Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, Endometrial Hyperplasia, Pelvic Organ Prolapse (POP)
Enrollment 2,000 participants
Start Date 2025-10-01
Primary Completion 2036-07-01 (estimated)
Study Completion 2037-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-22