A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement in the Patient Global Impression of Improvement (PGI-I) rating
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm II (usual care)
Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
干预措施: questionnaire administration (Other)
Arm II (usual care)
Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
干预措施: standard follow-up care (Procedure)
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.
干预措施: questionnaire administration (Other)
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.
干预措施: educational intervention (Other)
结局指标
主要结局
Improvement in the Patient Global Impression of Improvement (PGI-I) rating
时间窗: 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).
次要结局
- Changes in the Incontinence Severity Index (ISI) score(Baseline to 3 months)
- Changes in Urinary Distress Inventory (UDI)(Baseline to 3 months)
- Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life(Baseline to 3 months)