POPQ Associated With Total Laparoscopic Hysterectomy

NCT ID: NCT07137299

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2037-07-01

Brief 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

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)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Lap-hyst

Women who underwent laparoscopic hysterectomy for benign conditions

Questionnaire and Physical Exam

Intervention Type: OTHER

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

Robot-hyst

Women who underwent robotic hysterectomy for benign conditions

Questionnaire and Physical Exam

Intervention Type: OTHER

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

Vaginal-Hyst

Women who underwent vaginal hysterectomy for benign conditions

Questionnaire and Physical Exam

Intervention Type: OTHER

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

Abdom-Hyst

Women who underwent abdominal hysterectomy for benign conditions

Questionnaire and Physical Exam

Intervention Type: OTHER

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

SAH

Women who underwent supracervical abdominal hysterectomy for benign conditions

Questionnaire and Physical Exam

Intervention Type: OTHER

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

LASH

Women who underwent Laparoscopic Assisted Supracervical Hysterectomy for benign conditions

Questionnaire and Physical Exam

Intervention Type: OTHER

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• persons who underwent total or subtotal hysterectomy for benign conditions regardless of the type of surgery
• agree to participate and to follow-up

Exclusion Criteria

• having uterus
• health state - ECOG >2
• pelvic organ prolapse prior to the surgery
• surgery due to malignant conditions (ovarian, cervical or endometrial cancer)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Boniface Hospital

OTHER

Sponsor Role: collaborator

Klinika Ginekologii i Ginekologii Onkologicznej CMKP

UNKNOWN

Sponsor Role: collaborator

I Klinika Położnictwa i Ginekologii, Wydział Lekarski Warszawski Uniwersytet Medyczny

UNKNOWN

Sponsor Role: collaborator

Medical University of Silesia

OTHER

Sponsor Role: lead

Responsible Party

Krzysztof Nowosielski

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

Poland

Central Contacts

Krzysztof Nowosielski, professor

Role: CONTACT

knowosielski@sum.edu.pl

+48 502027943

Facility Contacts

Rafał Stojko, Professor

Role: primary

katowice@bcmbonifratrzy.pl

32 357 62 10 ext. +48

Artur Ludwin, Professor

Role: primary

artur.ludwin@wum.edu.pl

22 583 03 01 ext. +48

Filip Dąbrowski, Professor

Role: primary

ginekologia@bielanski.med.pl

22 56-90-274 ext. +48

Other Identifiers

POP-LAP1

Identifier Type: -

Identifier Source: org_study_id