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
This trial does not accept healthy volunteersQualifiers
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 population
All women operated in selected time-frame in study centers for benign conditions
Trial design
Other
Prospective
Treatments tested in this trial
Questionnaire and Physical Exam
Other interventionAll 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
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Assessment of the impact of different types of hysterectomy/uterine amputation on the incidence of urinary incontinence
Ingelmann-Sundberg scale for symptoms of stress urinary incontinence. The Ingelmann-Sundberg scale is a grading system used to assess the severity of stress urinary incontinence (SUI). It categorizes SUI based on the degree of physical activity that provokes urine leakage. The scale has three grades, with Grade I being the mildest and Grade III the most severe. Grade I - Urine leakage occurs with a relevant increase in abdominal pressure, such as during coughing, sneezing, or laughing. Grade II - Urine leakage occurs with a lesser increase in abdominal pressure, such as during activities like running, picking up objects from the floor, or walking. Grade III - Urine leakage occurs with minimal physical exertion, such as during walking, stair climbing, or even while standing or lying down. The assessment is based on medical interview with the patient performed during clinical visit.
Assessment of the impact of different types of hysterectomy/uterine amputation on the incidence of overactive bladder.
OABSS Overactive Bladder Symptom Score (OABSS) was used to assess symptoms of overactive bladder. The scale consists of 7 questions on a five-point Likert scale that refer to every symptom of OAB: 1 for nocturia, 1 for urinary frequency, 3 for urgency, 1 for urge incontinence, and 1 generic question about bladder control. The total result is scored from 0 to 28, with patients with higher scores reporting worse symptoms.
Assessment of the impact of different types of hysterectomy/uterine amputation on the incidence of pelvic organ prolapse
POPQ - Pelvic Organ Prolapse-Quantification. The assessment is based on gynecological examination. The system measures the position of the most distal portion of the prolapse to the hymen level. 5 stages are described: * Stage 0: No prolapse * Stage I: Most distal prolapse is more than 1 cm above the hymen * Stage II: Most distal prolapse is between 1 cm above and 1 cm below the hymen * Stage III: Most distal prolapse is more than 1 cm below hymen but 2 cm shorter than total vaginal length * Stage IV: Complete eversion
Secondary outcomes
Complications
Assessment of complications after hysterectomy/uterine amputation based on Clavien-Dindo Classification. The Clavien-Dindo Classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). It assesses the complications of the surgery in order to rank them in an objective and reproducible manner. Grade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II- Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III - Requiring surgical, endoscopic or radiological intervention Grade IV - Life-threatening complication (including CNS complications) requiring Intensive Care Unit management Grade V - Death of a patient
Assessment of the impact of different types of hysterectomy/uterine amputation on quality of life - by using P-QOL
P-QOL - Prolapse Quality of Life Questionnaire. The scale consisted of 38 questions, with 20 questions representing nine quality of life domains (general health perception, prolapse impact, role and physical limitations, social limitations, personal relationships, emotional problems, sleep/energy disturbances and symptoms severity) and 18 questions about prolapse symptoms. The responses ranged from "none/not at all" through "slightly/a little" and "moderately" to "a lot". A four-point scoring system for each item is used for severity measurement of urogenital prolapse symptoms. The questionnaire does not form the combined score. If a woman has only one domain affected and another woman has all domains affected, both will be considered symptomatic but in different aspects of life quality. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.
Assessment of the impact of different types of hysterectomy/uterine amputation on quality of life - by using POPDI-6
POPDI-6 - Pelvic Organ Prolapse Inventory 6. The scale is a six-item questionnaire used to assess the level of distress caused by pelvic organ prolapse symptom. Each of the six items is scored on a scale, ranging from 0 to 4, where 0 represents no distress and higher scores indicate greater distress. The scores range from 0 to 24, where higher scores indicate greater distress from pelvic organ prolapse symptoms
Assessment of the impact of different types of hysterectomy/uterine amputation on quality of life - by using PFIQ-7
PFIQ-7 - Pelvic Floor Impact Questionnaire short form is a 7-item questionnaire used to assess the impact of pelvic floor disorders on a woman's quality of life. It measures the impact of urinary symptoms (UIQ-7), pelvic organ prolapse symptoms (PIPQ-7) and colorectal/anal symptoms (CRAIQ-7) on daily life. Each item is scored on a Likert scale (0, Not at all; 1, somewhat; 2, moderately; 3, quite a bit), and scores from each scale can be combined to provide an overall impact score. The score for subscale ranges from 0 to 100 and for total score - 0-300. Higher scores represent greater impact on daily life.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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