POPQ Associated With Total Laparoscopic Hysterectomy

NCT07137299 | Not Yet Recruiting

• 1 other identifier: POP-LAP1
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 4

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

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

Outcome Measures

Primary Outcomes (3)

• 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: * 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

  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

  up to 30 days postoperatively

• Assessment of the impact of different types of hysterectomy/uterine amputation on quality of life - by using P-QOL

  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

  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

  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.

Study Arms (6)

Lap-hyst

Women who underwent laparoscopic hysterectomy for benign conditions

Other: Questionnaire and Physical Exam

Robot-hyst

Women who underwent robotic hysterectomy for benign conditions

Other: Questionnaire and Physical Exam

Vaginal-Hyst

Women who underwent vaginal hysterectomy for benign conditions

Other: Questionnaire and Physical Exam

Abdom-Hyst

Women who underwent abdominal hysterectomy for benign conditions

Other: Questionnaire and Physical Exam

SAH

Women who underwent supracervical abdominal hysterectomy for benign conditions

Other: Questionnaire and Physical Exam

LASH

Women who underwent Laparoscopic Assisted Supracervical Hysterectomy for benign conditions

Other: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical Exam 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; LASH; Lap-hyst; Robot-hyst; SAH; Vaginal-Hyst

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women operated in selected time-frame in study centers for benign conditions

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Silesia: lead
• St. Boniface Hospital: collaborator
• Klinika Ginekologii i Ginekologii Onkologicznej CMKP: collaborator
• I Klinika Położnictwa i Ginekologii, Wydział Lekarski Warszawski Uniwersytet Medyczny: collaborator

Study Sites (4)

Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia

Katowice, Silesian Voivodeship, 40-752, Poland

Location

Department of Obstetrics and Gynecology, Szpital Zakonu Bonifratrów pw. Aniołów Stróżów

Katowice, Poland

Location

Department of Gynecology and Obstetrics, Medical University of Warsaw

Warsaw, Poland

Location

Department of Gynecology and Obstetrics, Szpital Bielański

Warsaw, Poland

Location

MeSH Terms

Conditions

Leiomyoma; Endometrial Hyperplasia; Pelvic Organ Prolapse

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Krzysztof Nowosielski, professor

CONTACT

+48 502027943; knowosielski@sum.edu.pl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2036
• Study Completion (Estimated): July 1, 2037
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01.07.2026 - indefinitely
• Access Criteria: All academic researches on request

Locations

PL (4)