POPQ Associated With Total Laparoscopic Hysterectomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-85
SponsorMedical University of Silesia

About this trial

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

Eligibility criteria

Qualifiers

persons who underwent total or subtotal hysterectomy for benign conditions regardless of the type of surgery

agree to participate and to follow-up

Disqualifiers

having uterus

health state - ECOG >2

pelvic organ prolapse prior to the surgery

surgery due to malignant conditions (ovarian, cervical or endometrial cancer)

Trial design

Treatments tested in this trial

  • Questionnaire and Physical Exam

Treatment groups

2,000 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Medical University of Silesia

Lead sponsor

St. Boniface Hospital

Collaborator

Klinika Ginekologii i Ginekologii Onkologicznej CMKP

Collaborator

I Klinika Położnictwa i Ginekologii, Wydział Lekarski Warszawski Uniwersytet Medyczny

Collaborator