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临床试验/NCT03265509
NCT03265509已完成不适用

Assessment of the Effect of Glutamine Supplementation in Addition to Exercise on Pelvic Floor Muscle Strength and Clinical Parameters in Women With Urinary Incontinence or Pelvic Organ Prolapse

Istanbul University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Pelvic floor muscle strength with digital palpation

研究概览

简要总结

The objective of this study is to determine to effect of additional oral glutamine to Kegel exercises on pelvic floor strength and clinical parameters of urinary incontinence in females with either urinary incontinence (stress and/or urgency) and pelvic prolapse.

详细描述

Urinary incontinence is a prevalent and costly condition that affects approximately 38% of older community-dwelling women (age>60 years). Incontinence predisposes patients to other health problems, contributes to depression and social isolation, is a significant source of dependency among the elderly, and is widely cited as a factor in nursing home admissions. Sarcopenia is age-related and is characterized by loss of muscle mass, strength and endurance. There is not only a decrease in the number of muscle fibers, but also atrophy in the remaining ones. Several studies indicate glutamine supplementations lead to better muscle performance by stimulate muscle producing in extremities. Similarly, we assume glutamine supplementation could increase pelvic muscle mass and improve the pelvic floor strength. From this point, using glutamine supplementation may effect positively on stress, urge or mixed incontinence, and pelvic prolapse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal muscle strength in gynaecological examination

排除标准

  • Uncontrolled diabetes
  • Cognitive dysfunction hampering participation in exercise or assessment

研究组 & 干预措施

Glutamine

Active Comparator

30 g/day Glutamine supplementation for three months

干预措施: glutamine supplementation (Dietary Supplement)

Fantomalt

Placebo Comparator

30 g/day Fantomalt supplementation for three months

干预措施: fantomalt supplementation (Dietary Supplement)

结局指标

主要结局

Pelvic floor muscle strength with digital palpation

时间窗: 3 months

digital vaginal palpation method

Pelvic floor muscle strength with dynamometer

时间窗: 3 months

vaginal dynamometer

次要结局

  • general quality of life(3 months)
  • body composition(3 months)
  • 24 hour pad test(3 months)
  • degree of prolapse(3 months)
  • quality of life related prolapse(3 months)
  • hand grip strength(3 months)
  • urinary incontinence dairy(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulistan Bahat-Ozturk

Associate Professor

Istanbul University

研究点 (2)

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