Effectiveness and Safety of a Novel Volumetric Cross-Shaped Vaginal Pessary for the Management of Pelvic Organ Prolapse: A Prospective Multicenter Within-Subject Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 5
- 主要终点
- Change in Pelvic Floor Distress Inventory (PFDI-20) Score
研究概览
简要总结
This prospective multicenter single-arm study evaluates the effectiveness and safety of a novel volumetric cross-shaped vaginal pessary in women with pelvic organ prolapse who had prior experience using a traditional vaginal pessary. Each participant serves as her own control by comparing outcomes after fitting of the cross-shaped pessary with documented baseline outcomes during prior traditional pessary use.
详细描述
Women aged 18 years and older with pelvic organ prolapse stage II or higher and at least 12 weeks of prior traditional pessary use were enrolled at five Ukrainian medical centers. At baseline, the previous pessary was replaced with a volumetric cross-shaped vaginal pessary made of medical-grade silicone. Follow-up assessments were performed at approximately 1 month, 3 months, and 6 months. Assessments included pelvic organ prolapse quantification, Baden-Walker grading, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, pain by visual analogue scale, Patient Global Impression measures, continuation status, patient preference, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was used because the investigational pessary is visibly and physically distinct from traditional vaginal pessary types.
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
- •Female participants aged 18 years or older
- •Pelvic organ prolapse stage II or higher in any compartment
- •Current use of a traditional vaginal pessary for at least 12 consecutive weeks before enrollment
- •Willing and able to provide written informed consent
- •Able to attend scheduled follow-up visits or participate in telephone interviews
排除标准
- •Active vaginal or pelvic infection at enrollment
- •Pregnancy or planned pregnancy during the study period
- •History of pelvic radiation therapy
- •Severe vaginal atrophy with active erosion preventing pessary use
- •Planned surgical treatment for pelvic organ prolapse during the study period
- •Cognitive impairment or psychiatric condition precluding informed consent or protocol compliance
- •Known allergy to silicone
研究组 & 干预措施
Cross-Shaped Vaginal Pessary
Participants with pelvic organ prolapse and prior traditional pessary use are fitted with a volumetric cross-shaped vaginal pessary and followed for 6 months.
干预措施: Volumetric Cross-Shaped Vaginal Pessary (Device)
结局指标
主要结局
Change in Pelvic Floor Distress Inventory (PFDI-20) Score
时间窗: Baseline (month 0) and 3 months
Change in PFDI-20 total score from baseline (with previous pessary) to 3 months (with cross-shaped pessary). PFDI-20 score range 0-300; higher scores indicate greater symptom distress. Minimally clinically important difference (MCID) = 45 points. Tested with Wilcoxon signed-rank test.
Change From Baseline in Pelvic Floor Distress Inventory-20 Score at 3 Months
时间窗: Baseline and 3 months
The Pelvic Floor Distress Inventory-20 is a validated 20-item questionnaire for pelvic floor symptom distress. Scores range from 0 to 300, with higher scores indicating greater symptom distress. Change from baseline to 3 months is analyzed.
次要结局
- Device continuation rate(6 months)
- Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Score(Baseline, 1 month, and 3 months)
- Change in prolapse grade (Baden-Walker classification)(Baseline and 3 months)
- Pain intensity (Visual Analog Scale)(Baseline, 1 month, and 3 months)
- Adverse events(Through 6 months)
- Patient Global Impression of Improvement (PGI-I)(6 months)
- Patient Global Impression of Severity (PGI-S)(6 months)
- Patient preference(6 months)
- Device Continuation Rate at 6 Months(6 months)
- Change From Baseline in Pelvic Floor Impact Questionnaire-7 Score at 3 and 6 Months(Baseline, 3 months, and 6 months)
- Change From Baseline in Pelvic Organ Prolapse Quantification Stage at 1, 3, and 6 Months(Baseline, 1 month, 3 months, and 6 months)
- Change From Baseline in Baden-Walker Grade at 1, 3, and 6 Months(Baseline, 1 month, 3 months, and 6 months)
- Change From Baseline in Pain Visual Analogue Scale Score at 1, 3, and 6 Months(Baseline, 1 month, 3 months, and 6 months)
- Patient Global Impression of Improvement at 3 and 6 Months(3 months and 6 months)
- Patient Global Impression of Severity at 3 and 6 Months(3 months and 6 months)
- Patient Preference for Cross-Shaped Pessary at 6 Months(6 months)
- Incidence of Device-Related Adverse Events Through 6 Months(Through 6 months)
研究者
Mykhailo Medvediev
Professor and Head, Department of Obstetrics and Gynecology
Dnipro State Medical University