Uterine Fibroids (UF)POP-LAPNCT07137299
POPQ Associated With Total Laparoscopic Hysterectomy
An observational study of Uterine Fibroids (UF) and Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, run by Medical University of Silesia at 4 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Uterine Fibroids (UF), Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, Endometrial Hyperplasia
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 2,000 participants
- Where
- 4 sitesPoland
- Study dates
- 1 Oct 2025to 1 Jul 2037
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women operated in selected time-frame in study centers for benign conditions
Who may be able to join
- persons who underwent total or subtotal hysterectomy for benign conditions regardless of the type of surgery
- agree to participate and to follow-up
Who cannot join
- having uterus
- health state - ECOG >2
- pelvic organ prolapse prior to the surgery
- surgery due to malignant conditions (ovarian, cervical or endometrial cancer)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland4 sites
Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia
Katowice, Silesian Voivodeship, 40-752
Department of Obstetrics and Gynecology, Szpital Zakonu Bonifratrów pw. Aniołów Stróżów
Katowice
Rafał Stojko, Professor, 32 357 62 10 ext. +48, katowice@bcmbonifratrzy.pl
Department of Gynecology and Obstetrics, Medical University of Warsaw
Warsaw
Artur Ludwin, Professor, 22 583 03 01 ext. +48, artur.ludwin@wum.edu.pl
Department of Gynecology and Obstetrics, Szpital Bielański
Warsaw
Filip Dąbrowski, Professor, 22 56-90-274 ext. +48, ginekologia@bielanski.med.pl
About this study
Official title: POPQ Associated With Total Laparoscopic Hysterectomy - Multicenter Prospective Observational Study - POP-LAP STUDY
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.
Read more
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
Read the detailed description
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:
- Does total laparoscopic hysterectomy increase the risk of pelvic organ prolapse or urinary incontinence compared to supracervical hysterectomy?
- Does total laparoscopic hysterectomy increase the risk of pelvic floor dysfunction compared to abdominal or vaginal approaches?
- Does the use of robotic techniques reduce the risk of pelvic floor dysfunction compared to conventional laparoscopic hysterectomy?
- Does robotic supracervical hysterectomy reduce the risk of pelvic floor dysfunction compared to standard laparoscopic supracervical hysterectomy?
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:
- 18 to 85 years old
- Willing to give informed consent
- Not suffering from severe chronic illness (ECOG ≥ 2)
- Not previously diagnosed with pelvic floor problems before surgery What Will Participants Be Asked to Do?
Participants will:
- Receive a letter inviting them to join the study
- Complete quality-of-life questionnaires (Prolapse Quality of Life Questionnaire (P-QOL), Pelvic Organ Prolapse Inventory 6 (POPDI-6), Pelvic Floor Impact Questionnaire short form ( PFIQ-7).every two years about symptoms related to pelvic floor dysfunction and urinary incontinence
- Undergo a gynecological exam every two years to assess healing and signs of prolapse using a standardized method (POP-Q) If a participant chooses not to have a physical exam, only questionnaire data will be used.
Where Is the Study Taking Place?
The study is being conducted at multiple leading medical centers in Poland:
- Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia in Katowice
- Department of Gynecology and Gynecological Oncology, CMKP, Warsaw
- Department of Gynecology and Obstetrics, Medical University of Warsaw
- Department of Obstetrics and Gynecology, Szpital Zakonu Bonifratrów pw. Aniołów Stróżów w Katowice
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?
- Start date: July 1, 2025
- End date: July 1, 2036 This long observation period allows researchers to understand how pelvic floor health changes years after surgery.
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.
- Conditions
- Uterine Fibroids (UF), Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, Endometrial Hyperplasia, Pelvic Organ Prolapse (POP)
- Being tested
- Questionnaire and Physical Exam
- Keywords
- Hysterectomy, Vaginal hysterectomy, Laparotomy, Laparoscopy, Robotic surgery, pelvic organ prolapse
- Medical subject headings
- Leiomyoma, Endometrial Hyperplasia, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
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
| Study group | Role | What they receive |
|---|---|---|
| Lap-hyst | Women who underwent laparoscopic hysterectomy for benign conditions Receives: Other: Questionnaire and Physical Exam | |
| Robot-hyst | Women who underwent robotic hysterectomy for benign conditions Receives: Other: Questionnaire and Physical Exam | |
| Vaginal-Hyst | Women who underwent vaginal hysterectomy for benign conditions Receives: Other: Questionnaire and Physical Exam | |
| Abdom-Hyst | Women who underwent abdominal hysterectomy for benign conditions Receives: Other: Questionnaire and Physical Exam | |
| SAH | Women who underwent supracervical abdominal hysterectomy for benign conditions Receives: Other: Questionnaire and Physical Exam | |
| LASH | Women who underwent Laparoscopic Assisted Supracervical Hysterectomy for benign conditions Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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:
- 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
Measured: 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.
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jul 2036 (estimated)
- Study completion1 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids (UF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- St. Boniface Hospital, Klinika Ginekologii i Ginekologii Onkologicznej CMKP, I Klinika Położnictwa i Ginekologii, Wydział Lekarski Warszawski Uniwersytet Medyczny
- Responsible party
- Principal investigator, Krzysztof Nowosielski, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137299
- Sponsor's protocol ID
- POP-LAP1
- Acronym
- POP-LAP
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data (all) will be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POPQ Associated With Total Laparoscopic Hysterectomy - Multicenter Prospective Observational Study - POP-LAP STUDY
- ClinicalTrials.gov ID
- NCT07137299
- Acronym / sponsor ID
- POP-LAP / POP-LAP1
- Conditions
- Uterine Fibroids (UF), Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, Endometrial Hyperplasia, Pelvic Organ Prolapse (POP)
- Keywords
- Hysterectomy, Vaginal hysterectomy, Laparotomy, Laparoscopy, Robotic surgery, pelvic organ prolapse
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- St. Boniface Hospital, Klinika Ginekologii i Ginekologii Onkologicznej CMKP, I Klinika Położnictwa i Ginekologii, Wydział Lekarski Warszawski Uniwersytet Medyczny
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jul 2036 (estimated)
- Study completion
- 1 Jul 2037 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- Does total laparoscopic hysterectomy increase the risk of pelvic organ prolapse or urinary incontinence compared to supracervical hysterectomy?
- Does total laparoscopic hysterectomy increase the risk of pelvic floor dysfunction compared to abdominal or vaginal approaches?
- Does the use of robotic techniques reduce the risk of pelvic floor dysfunction compared to conventional laparoscopic hysterectomy?
- Does robotic supracervical hysterectomy reduce the risk of pelvic floor dysfunction compared to standard laparoscopic supracervical hysterectomy?
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:
- 18 to 85 years old
- Willing to give informed consent
- Not suffering from severe chronic illness (ECOG ≥ 2)
- Not previously diagnosed with pelvic floor problems before surgery What Will Participants Be Asked to Do?
Participants will:
- Receive a letter inviting them to join the study
- Complete quality-of-life questionnaires (Prolapse Quality of Life Questionnaire (P-QOL), Pelvic Organ Prolapse Inventory 6 (POPDI-6), Pelvic Floor Impact Questionnaire short form ( PFIQ-7).every two years about symptoms related to pelvic floor dysfunction and urinary incontinence
- Undergo a gynecological exam every two years to assess healing and signs of prolapse using a standardized method (POP-Q) If a participant chooses not to have a physical exam, only questionnaire data will be used.
Where Is the Study Taking Place?
The study is being conducted at multiple leading medical centers in Poland:
- Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia in Katowice
- Department of Gynecology and Gynecological Oncology, CMKP, Warsaw
- Department of Gynecology and Obstetrics, Medical University of Warsaw
- Department of Obstetrics and Gynecology, Szpital Zakonu Bonifratrów pw. Aniołów Stróżów w Katowice
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?
- Start date: July 1, 2025
- End date: July 1, 2036 This long observation period allows researchers to understand how pelvic floor health changes years after surgery.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lap-hyst | – | Other: Questionnaire and Physical ExamWomen who underwent laparoscopic hysterectomy for benign conditions |
| Robot-hyst | – | Other: Questionnaire and Physical ExamWomen who underwent robotic hysterectomy for benign conditions |
| Vaginal-Hyst | – | Other: Questionnaire and Physical ExamWomen who underwent vaginal hysterectomy for benign conditions |
| Abdom-Hyst | – | Other: Questionnaire and Physical ExamWomen who underwent abdominal hysterectomy for benign conditions |
| SAH | – | Other: Questionnaire and Physical ExamWomen who underwent supracervical abdominal hysterectomy for benign conditions |
| LASH | – | Other: Questionnaire and Physical ExamWomen who underwent Laparoscopic Assisted Supracervical Hysterectomy for benign conditions |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women operated in selected time-frame in study centers for benign conditions
Key inclusion criteria (2 listed)
- persons who underwent total or subtotal hysterectomy for benign conditions regardless of the type of surgery
- agree to participate and to follow-up
Key exclusion criteria (4 listed)
- having uterus
- health state - ECOG >2
- pelvic organ prolapse prior to the surgery
- surgery due to malignant conditions (ovarian, cervical or endometrial cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamAll 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 | Other | Abdom-Hyst, LASH, Lap-hyst, Robot-hyst, SAH, Vaginal-Hyst |
Primary outcome
Assessment of the impact of different types of hysterectomy/uterine amputation on the incidence of urinary incontinence
Time frame: 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.
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.
Time frame: 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.
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
Time frame: 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.
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
4 secondary outcomes
Complications
Time frame: up to 30 days postoperatively
Assessment of the impact of different types of hysterectomy/uterine amputation on quality of life - by using P-QOL
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Yes. Anonymized data (all) will be shared on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids (UF) and Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, run by Medical University of Silesia at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Nowosielski, professor (+48 502027943, knowosielski@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the impact of different types of hysterectomy/uterine amputation on the incidence of urinary incontinence (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.