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| Name | Class |
|---|---|
| St. Boniface Hospital | OTHER |
| Klinika Ginekologii i Ginekologii Onkologicznej CMKP | UNKNOWN |
| I Klinika Położnictwa i Ginekologii, Wydział Lekarski Warszawski Uniwersytet Medyczny | UNKNOWN |
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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:
This prospective, non-commercial, multicenter study plans to enroll 2,000 women and will run from July 1, 2025, to July 1, 2036
What Is This Study About? This is a long-term observational study that aims to understand whether different surgical techniques for removing the uterus affect women's risk of developing pelvic floor disorders, such as pelvic organ prolapse (POP) or urinary incontinence, after surgery.
Pelvic organ prolapse occurs when pelvic organs like the uterus or bladder drop from their normal position and push against the vaginal walls. It is a common condition, especially in women after menopause, and can significantly affect quality of life.
Why Is This Study Important? Each year, thousands of women undergo hysterectomies (surgical removal of the uterus) for non-cancerous reasons. However, it's still unclear whether certain types of hysterectomy procedures may lead to a higher or lower risk of pelvic floor problems in the years following surgery. This study seeks to provide reliable answers to help improve patient safety and long-term outcomes.
What Questions Is the Study Trying to Answer?
The main questions it aims to answer are:
Who Can Participate? The study will include about 2,000 women who had their uterus removed or partially removed between 2021 and 2025 for benign conditions.
Participants must be:
Participants will:
Where Is the Study Taking Place?
The study is being conducted at multiple leading medical centers in Poland:
Is the Study Safe? Yes. This is an observational study, which means no new treatments or procedures are being tested. It involves only questionnaires and routine medical exams, so there is no additional risk to the participants.
When Will the Study Take Place?
What Do Researchers Hope to Achieve? The ultimate goal is to guide medical professionals and patients in choosing the most appropriate surgical technique for removing the uterus for benign causes, based on long-term outcomes. By identifying which methods are safer for pelvic floor health, this research could help reduce the number of women who develop prolapse or incontinence after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lap-hyst | Women who underwent laparoscopic hysterectomy for benign conditions |
| |
| Robot-hyst | Women who underwent robotic hysterectomy for benign conditions |
| |
| Vaginal-Hyst | Women who underwent vaginal hysterectomy for benign conditions |
| |
| Abdom-Hyst | Women who underwent abdominal hysterectomy for benign conditions |
| |
| SAH | Women who underwent supracervical abdominal hysterectomy for benign conditions |
| |
| LASH | Women who underwent Laparoscopic Assisted Supracervical Hysterectomy for benign conditions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire and Physical Exam | Other | All study participants will be evaluated to assess:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and at 2-year intervals (Year 2, Year 4, Year 6, Year 8, and Year 10) through study completion; on average of 10 years. |
| 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. | At baseline and at 2-year intervals (Year 2, Year 4, Year 6, Year 8, and Year 10) through study completion; on average of 10 years. |
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All women operated in selected time-frame in study centers for benign conditions
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krzysztof Nowosielski, professor | Contact | +48 502027943 | knowosielski@sum.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia | Katowice | Silesian Voivodeship | 40-752 | Poland |
Anonymized data (all) will be shared on request
01.07.2026 - indefinitely
All academic researches on request
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D004714 | Endometrial Hyperplasia |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| At baseline and at 2-year intervals (Year 2, Year 4, Year 6, Year 8, and Year 10) through study completion; on average of 10 years. |
| up to 30 days postoperatively |
| 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. | At baseline and at 2-year intervals (Year 2, Year 4, Year 6, Year 8, and Year 10) through study completion; on average of 10 years. |
| 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 | At baseline and at 2-year intervals (Year 2, Year 4, Year 6, Year 8, and Year 10) through study completion; on average of 10 years. |
| 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. | At baseline and at 2-year intervals (Year 2, Year 4, Year 6, Year 8, and Year 10) through study completion; on average of 10 years. |
| 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 |
|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |