POPQ Associated With Total Laparoscopic Hysterectomy - Multicenter Prospective Observational Study - POP-LAP STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 4
- 主要终点
- Assessment of the impact of different types of hysterectomy/uterine amputation on the incidence of urinary incontinence
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •persons who underwent total or subtotal hysterectomy for benign conditions regardless of the type of surgery
- •agree to participate and to follow-up
排除标准
- •having uterus
- •health state - ECOG >2
- •pelvic organ prolapse prior to the surgery
- •surgery due to malignant conditions (ovarian, cervical or endometrial cancer)
结局指标
主要结局
Assessment of the impact of different types of hysterectomy/uterine amputation on the incidence of urinary incontinence
时间窗: 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.
时间窗: 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
时间窗: 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
次要结局
- 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.)
研究者
Krzysztof Nowosielski
Prof.
Medical University of Silesia