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临床试验/NCT01194999
NCT01194999已完成4 期

Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

Barrie Urology Associates2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
132
试验地点
2
主要终点
Change in OAB Symptoms Post Pubovaginal Sling Operation

研究概览

简要总结

Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Other overactive bladder (OAB) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however, suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be alleviated by said procedure. It is our aim to investigate this relationship in our clinic.

As a prospective member of this study, you will be asked to complete five surveys. The first survey will be administered prior to your pubovaginal sling. This will be used to establish your baseline experience of OAB. Over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.

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

性别
Female
接受健康志愿者

入选标准

  • Post-pubovaginal sling patient.
  • Complete agreement and signing of Informed Consent Form.

排除标准

  • Currently taking antimuscarinics or α1 blockers.
  • Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.

结局指标

主要结局

Change in OAB Symptoms Post Pubovaginal Sling Operation

时间窗: Baseline to final follow-up.

Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.

次要结局

未报告次要终点

研究者

发起方
Barrie Urology Associates
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Joseph Zadra

Chief of Urology, RVH

Barrie Urology Associates

研究点 (2)

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