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临床试验/NCT02111642
NCT02111642已完成不适用

Effect of a New Risk Calculator on Patient Satisfaction With the Decision for Concomitant Midurethral Sling During Prolapse Surgery

Medstar Health Research Institute2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Satisfaction with Decision Scale for Pelvic Floor Disorders

研究概览

简要总结

Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is the only option which potentially offers a cure.

It is well known that women with pelvic organ prolapse are at risk of developing new stress urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing, coughing, or laughing. Previous studies have demonstrated that the addition of a prophylactic anti-incontinence procedure at the time of prolapse surgery reduces this risk. One example of such a procedure is a mesh sling placed underneath the urethra (midurethral sling). Nevertheless, the decision to place a midurethral sling to prevent stress urinary incontinence after prolapse surgery remains controversial.

A new risk calculator tool has been developed to provide patients' with their individualized risk of developing de novo stress urinary incontinence after prolapse surgery. The primary objective of this study is to determine whether use of this new personalized online risk calculator tool increases patient satisfaction with the decision whether or not to have a midurethral sling placed at the time of prolapse surgery to prevent development of stress urinary incontinence. The investigators hypothesize that use of this tool will increase patient satisfaction with their decision regarding midurethral sling placement.

详细描述

The investigators plan to conduct a randomized, controlled clinical trial involving women with pelvic organ prolapse planning to have prolapse surgery with 1 of 4 fellowship-trained Urogynecologists at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center in Washington, DC. Women will be recruited prior to their preoperative counseling sessions during routine office visits and/or by telephone. After obtaining informed consent, women who agree to participate will be randomized to preoperative counseling sessions where an online risk calculator tool for the development of postoperative de novo stress urinary incontinence is or is not used. This tool is accessible at no cost from the following website: http://www.r-calc.com/ExistingFormulas.aspx?filter=CCQHS. At the time of these sessions, participants will decide whether to have a midurethral sling placed at the time of their prolapse repair to prevent development of stress urinary incontinence after surgery. After making this decision, all participants will complete the validated Satisfaction with Decision Scale to assess their satisfaction with their decision regarding midurethral sling placement. This validated 6-item self-administered questionnaire with a 5 point response scale takes approximately 3 minutes to complete. Participants will complete the Satisfaction with Decision Scale a second time at the time of their 2 week postoperative visit. Three months after surgery, participants will complete the Satisfaction with Decision Scale a third time, along with other validated quality of life questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • ≥ Stage 2 pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification system (POP-Q)
  • Desire for prolapse surgery
  • No symptoms of stress urinary incontinence preoperatively
  • English-speaking

排除标准

  • Symptoms of stress urinary incontinence preoperatively
  • History of previous prolapse or anti-incontinence surgery
  • Pregnancy
  • Dementia or other cognitive impairment
  • Unable or unwilling to complete post-operative questionnaires

结局指标

主要结局

Satisfaction with Decision Scale for Pelvic Floor Disorders

时间窗: 3 months postoperative

The primary outcome will be patient satisfaction with the decision for concomitant midurethral sling placement at 3 months postoperative in the intervention (risk calculator tool) group versus the control group, assessed using the Satisfaction with Decision Scale for Pelvic Floor Disorders.

次要结局

未报告次要终点

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeannine Miranne

MD, MS, Fellow, Female Pelvic Medicine and Reconstructive Surgery

Medstar Health Research Institute

研究点 (2)

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