Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Prolapse Symptom Severity
研究概览
简要总结
This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally, we will assess the impact that preoperative pessary use has on patient self-reported preparedness for surgery.
详细描述
It is anticipated that this trial will define the clinical utility of routine preoperative pessary placement, and by shaping patient expectations and increasing preparedness for surgery, we anticipate improving satisfaction and quality of life.
At the initial office visit baseline symptoms are evaluation with validated questionnaire.
The patients' will undergo pessary fitting at least 7 days (but no more than 28 days) prior to scheduled surgical prolapse repair.
Symptomatic change from baseline will be assessed with validated questionnaire preoperatively.
The pessary will be removed at the time of surgery, and the patient will undergo surgical correction of their pelvic organ prolapse (including all restorative surgical procedures, abdominal and transvaginal). A concomitant anti-incontinence procedure will be performed at the discretion of the treating physician in consultation with the patient.
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
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
- •Older than 18 years of age
- •With symptomatic pelvic organ prolapse
- •Electing for surgical repair of pelvic organ prolapse (transvaginal or transabdominal) at least 7 days after office consultation
- •Understand and have signed written informed consent for preoperative pessary placement.
排除标准
- •Previous use of a pessary for pelvic organ prolapse
- •Patients undergoing obliterative prolapse surgery (i.e. Colpocleisis),
- •Are scheduled for surgery for pelvic organ prolapse less than 7 days after office consultation or greater than 4 weeks after office consultation
- •Have an isolated rectocele
- •Have allergies to both latex and silicone
- •Have an active pelvic infection
结局指标
主要结局
Prolapse Symptom Severity
时间窗: Baseline, 3 month post surgery
Mean value of score on self-reported Pelvic Organ Prolapse Distress Inentory-6 (POPDI-6) questionnaire. Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.
Patient Global Impression of Improvement (PGI-I) Score
时间窗: 3 months postoperatively
Number of participants considered treatment success assessed using the 7-point Likert scale of the Patient Global Impression of Improvement (PGI-I) of 1= very much better and 7=very much worse. Patient's will be considered treatment success if they answer "much better" or "very much better" on the PGI-I scale.
Bother of Bladder/Vaginal/Bowel Symptoms
时间窗: Baseline, 3 month post surgery
Mean value of score on self-reported Floor Impact Questionnaire-7 (PFIQ-7). Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.
Overactive Bladder Symptom Score (OABSS)
时间窗: Baseline, 3 month post surgery
Mean value of score on self-reported Overactive Bladder Symptom Score (OABSS) questionnaire. Minimum scale score = 0; maximum scale score = 15 and a higher score indicates worse outcome.
次要结局
未报告次要终点
研究者
John A. Occhino
Assistant Professor of Obstetrics-Gynecology
Mayo Clinic