Enabling Self-Care for Pessary Users in Rural Setting
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analogue Score (VAS): satisfaction of prolapse management.
研究概览
简要总结
This study is to see if a using new collapsible pessary (Reia pessary) for treatment of pelvic organ prolapse will allow patients to care for their prolapse on their own, rather than having to come to be seen by a provider in the office regularly (2-4 times per year) to manage the pessary. Enrollment in the study will be offered to current patients who have regular office visits to care for their pessary.
详细描述
This is a prospective interventional trial for patients with at least stage 2 pelvic organ prolapse (POP), who are currently managing their POP with office-based care using a pessary. The study will be conducted at two institutions, Dartmouth-Hitchcock and Pennsylvania State University. The intervention will be to convert willing patients from office-based care to self-care, using a new, collapsible (Reia) pessary in patients. The primary outcome will be a visual analog score (VAS) regarding their current satisfaction with their treatment and management of POP. Secondary outcomes will include questionnaires on impact, travel for care and self-care. The comparison group will be patients who decline to try the new pessary but agree to questionnaires regarding their current office-based care for pessary management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Women currently using office-based pessary management of at least stage 2 POP will be recruited:
- •English-speaking natal females 18 years or older
- •Stage II-IV POP desiring continued pessary management.
- •Primary indication for pessary management is treatment of POP
排除标准
- •Primary indication for pessary is for management of stress urinary incontinence
- •Vesicovaginal fistula or rectovaginal fistula
- •Vaginal, rectal or bladder malignancy
- •Genitourinary infection requiring treatment*
- •Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis)*
- •Inflammatory bowel disease (Crohn's or ulcerative colitis)
- •Pelvic or anorectal chronic pain
- •Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery
- •Congenital malformation of the bladder, rectum or vagina
- •The following special populations will be excluded:
- •Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women (or planning pregnancy in the next 6 months) (women of childbearing age will be verbally queried and offered pregnancy testing if uncertain) Prisoners
- •*Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment and have resolution of symptoms
研究组 & 干预措施
Self-Care
Subjects who switch to new, collapsible pessary and convert to self-management for care of their pelvic organ prolapse.
干预措施: Reia System pessary self-care management (Device)
Office-Care
Subjects who continue office-based pessary care of their pelvic organ prolapse with visits every 3-6 months annually.
干预措施: Standard pessary office-based management (Device)
结局指标
主要结局
Visual Analogue Score (VAS): satisfaction of prolapse management.
时间窗: Baseline, 3 months, 6 months
Patient reported Visual Analogue Score for (0-100mm) for satisfaction of prolapse management.
次要结局
- Pessary Sexual Questionnaire(Baseline, 6 months)
- modified Patient Experience with Treatment and Self-Management (mPETS) Questionnaire(Baseline, 6 months)
- Patient Experience with Pessary Treatment and Self-Management (PEPS) Questionnaire(Baseline, 6 months)
- Patient Global Impression of Improvement (PGI-I)(3 months, 6 months)
- Patient Global Impression of Severity (PGI-S)(Baseline, 3 months, 6 months)
- Patient Global Symptoms Rating Scale (PGSC)(Baseline, 3 months, 6 months)
- Number of subjects with at least one adverse event(0-6 months)
- Log of pessary self-care events(0-6 months)
- Pessary Sexual Questionnaire(Baseline, 6 months)
- Pelvic Floor Impact Questionnaire - 7 (PFIQ-7)(Baseline, 6 months)
- Patient Global Impression of Improvement (PGI-I)(3 months, 6 months)
- Patient Global Impression of Severity (PGI-S)(Baseline, 3 months, 6 months)
- Patient Global Symptoms Rating Scale (PGSC)(Baseline, 3 months, 6 months)
- Log of pessary self-care events(0-6 months)
- modified Patient Experience with Treatment and Self-Management (mPETS) Questionnaire(Baseline, 6 months)
- Patient Experience with Pessary Treatment and Self-Management (PEPS) Questionnaire(Baseline, 6 months)
- Number of subjects with at least one adverse event(0-6 months)
研究者
Kris.Strohbehn
Principal Investigator
Dartmouth-Hitchcock Medical Center