POPQ Associated With Total Laparoscopic Hysterectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Eligibility

Primary outcome measure(s)

• Assessment of the impact of different types of hysterectomy/uterine amputation on the incidence of urinary incontinence — 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. — 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 — 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

Trial sites (4)

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