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POPQ Associated With Total Laparoscopic Hysterectomy
Sponsor: Medical University of Silesia
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
Official title: POPQ Associated With Total Laparoscopic Hysterectomy - Multicenter Prospective Observational Study - POP-LAP STUDY
Key Details
Gender
FEMALE
Age Range
18 Years - 85 Years
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2025-10-01
Completion Date
2037-07-01
Last Updated
2025-08-22
Healthy Volunteers
No
Conditions
Interventions
Questionnaire and Physical Exam
All study participants will be evaluated to assess: * Healing of the vaginal stump in the case of a total hysterectomy (normal/abnormal), * Symptoms of stress urinary incontinence (Ingelmann-Sundber scale, where 0 - no symptoms, Grade I - symptoms with coughing, pressure on the suprapubic area, laughing, or strenuous exertion, Grade II - loss of urine when levering, running, or climbing stairs, Grade III - loss of urine when lying down or standing without physical exertion) * Symptoms of an overactive bladder - present, absent * Symptoms of prolapse in the anterior and posterior compartments (assessed based on the POPQ scale) with an assessment of the defect site based on the de Lancey classification The examination will be performed by or with the assistance of a specialist in obstetrics and gynecology
Locations (4)
Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia
Katowice, Silesian Voivodeship, Poland
Department of Obstetrics and Gynecology, Szpital Zakonu Bonifratrów pw. Aniołów Stróżów
Katowice, Poland
Department of Gynecology and Obstetrics, Medical University of Warsaw
Warsaw, Poland
Department of Gynecology and Obstetrics, Szpital Bielański
Warsaw, Poland