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POPQ Associated With Total Laparoscopic Hysterectomy

NCT07137299 · Medical University of Silesia · Updated 22 Aug 2025

What is being tested
Questionnaire and Physical Exam
For
Uterine Fibroids (UF); Abnormal Uterine Bleeding Unrelated to Menstrual Cycle; Endometrial Hyperplasia; Pelvic Organ Prolapse (POP)
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 85 years. About 2,000 people. The full rules are on the registry page.
Where
Poland (4 sites)
When
Starts or started 1 Oct 2025, ends 1 July 2037. Registered 22 Aug 2025.
Results
None posted yet.

In the researchers' words

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
ClinicalTrials.gov, NCT07137299

Sites

  • Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of SilesiaKatowice, Silesian Voivodeship, Poland
  • Department of Obstetrics and Gynecology, Szpital Zakonu Bonifratrów pw. Aniołów StróżówKatowice, Poland
  • Department of Gynecology and Obstetrics, Medical University of WarsawWarsaw, Poland
  • Department of Gynecology and Obstetrics, Szpital BielańskiWarsaw, Poland