Pelvic Ultrasound Pessary Study: a Prospective Study for the Development of an Innovative Personalized Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 269
- 试验地点
- 1
- 主要终点
- anatomical changes in the pelvic floor after placement of pessary in midsagittal view
研究概览
简要总结
In the past, the impact of pessaries was mostly assessed by questionnaires on Quality of Life (QoL) and sexual dysfunction. This research project primarily aims to objectify the effects of the currently available pessaries in a different way. To accomplish this, the investigators choose transperineal ultrasound and uroflowmetry. Additionally, this project aims to describe the impact of pessaries on the symptoms and QoL.
详细描述
First, the investigators will carry out a small feasibility study with inclusion of 20 patients with pelvic organ prolapse (POP) already using a pessary to check if it is possible to perform adequate measurements of the pelvic floor on transperineal ultrasound with the pessary in situ. By doing this cross-sectional study, the investigators want to refine our technique to optimize data collection.
The study will be designed as a monocentric prospective longitudinal study. Patients presenting to our gynecology outpatient department with symptomatic POP, who choose to try a pessary after thorough counseling, will be recruited. The follow-up will continue for 1 year after the insertion of the pessary. Regular check-ups at 2 weeks, 3, 6, and 12 months will be performed to document patient-reported outcome measures (PROMs), perform a clinical examination. Transperineal ultrasound (TPUS) and uroflowmetry will be added to the examinations at the check-up at 3 and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •symptomatic POP
- •start of pessary therapy
- •patient must master Dutch, French or English
排除标准
- •active pelvic infection
- •severe vaginal ulceration
- •vaginitis
- •allergy to silicone and/or latex
- •non compliant patients
- •pregnancy
结局指标
主要结局
anatomical changes in the pelvic floor after placement of pessary in midsagittal view
时间窗: 1/1/2025
Anatomy of the pelvic floor will be assessed using 3D/4D ultrasound with the patient in a supine (or standing) position. Pelvic organ descent will be assessed in the midsagittal view on ultrasound, documenting: bladder neck descent (mm), bladder descent (mm), uterine/vault descent (mm), rectal ampulla descent (mm), rectocoele depth (mm). Measurements before and after pessary placement will be compared for each patient.
What changes in QoL are reported by patients?
时间窗: 1/1/2025
The investigators aim to evaluate improvements in POP-related symptoms and the Quality of Life (QoL) This will be measured by using the Pelvic Floor Distress Inventory (PFDI-20). Patients will be asked to fill out these questionnaires at the start of the treatment and at 3 and 12 months.
What changes in micturition and sexual function are reported by patients?
时间窗: 1/1/2025
The investigators aim to evaluate improvements in POP-related symptoms, micturition, and sexual functions. This will be measured by using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Patients will be asked to fill out these questionnaires at the start of the treatment and at 3 and 12 months.
次要结局
- Is it possible to choose the best fitting pessary based on the measurements obtained by transperineal ultrasound?(1/1/2025)
- Does the use of a pessary changes flow rate during voiding?(1/1/2025)
- Does levator avulsion influence the success of pessary use?(1/1/2025)
- Does the use of a pessary changes the voiding time?(1/1/2025)
研究者
Prof Yves Jacquemyn
Professor dr. Yves Jacquemyn
Universiteit Antwerpen