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Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors

2013年3月6日 更新者:New Mexico Cancer Care Alliance

A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors

This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.

研究概览

详细说明

PRIMARY OBJECTIVES:

I. To assess whether pelvic floor muscle training and behavioral therapy in gynecologic cancer survivors results in improvement in incontinence symptoms as measured by a validated questionnaire (Patient Global Impression of Improvement) at three month follow-up when compared to women who do not undergo pelvic floor muscle training.

II. To evaluate whether women who undergo pelvic floor muscle training and behavioral therapy report greater improvement in validated urinary incontinence symptom severity, pelvic floor distress and quality of life measures than women who do not undergo pelvic floor muscle training.

III. To evaluate the acceptability of pelvic floor muscle training (PFMT) among gynecological cancer survivors and to provide preliminary data to inform a power analysis for a larger randomized trial.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.

ARM II: Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.

After completion of study treatment, patients are followed up at 3 months.

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • University of New Mexico Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • History of uterine, cervical, ovarian or vulvar malignancy
  • Treatment free interval of >= one year and currently have no evidence of cancer
  • Reports urinary incontinence based on screening questionnaire
  • Must have a stable address for the three month period

Exclusion Criteria:

  • Current clinical evidence of urinary tract infection
  • Within three months of failed surgery for urinary incontinence
  • Planned surgery for urinary incontinence in the next three months
  • Presence of neurologic condition that may impact bladder symptoms such as multiple sclerosis, stroke
  • Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Arm I (PFMT)
Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.
辅助研究
Undergo PFMT
其他名称:
  • 干预,教育
有源比较器:Arm II (usual care)
Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
辅助研究
Receive usual care

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Improvement in the Patient Global Impression of Improvement (PGI-I) rating
大体时间:12 weeks
Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Changes in the Incontinence Severity Index (ISI) score
大体时间:Baseline to 3 months
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
Baseline to 3 months
Changes in Urinary Distress Inventory (UDI)
大体时间:Baseline to 3 months
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
Baseline to 3 months
Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life
大体时间:Baseline to 3 months
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
Baseline to 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Teresa Rutledge, MD、University of New Mexico Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年11月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2013年3月5日

首先提交符合 QC 标准的

2013年3月6日

首次发布 (估计)

2013年3月7日

研究记录更新

最后更新发布 (估计)

2013年3月7日

上次提交的符合 QC 标准的更新

2013年3月6日

最后验证

2013年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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