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临床试验/NCT06599190
NCT06599190已完成2 期

Effect Of Abdominal Hypopressive Training On Stress Urinary IncontinenceIn Female Athletes

Badr University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月20日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Assessment of urine loss

研究概览

简要总结

Fifty female athletes suffering from stress incontinence (SUI) will participate in this study. They will be selected from El Zohour Club, New Cairo City.

详细描述

They will be randomly distributed into 2 groups equal in numbers:

Group (A) (Control group) consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.

Group (B) (Study group) consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.

Before data collection, the purpose and procedures will be fully explained to the females. Informed consent will be obtained from each female. Each female will be evaluated following a standard protocol.

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
Single (Outcomes Assessor)

盲法说明

single

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female athletes suffering from SUI.
  • •They will be diagnosed with SUI using bladder stress test.
  • •Their ages will range from 14-18 years old.
  • •Their body mass index (BMI) will range from 18.5-24.9 kg/m
  • •They are single females.

排除标准

  • •The female athlete will be excluded if they had:
  • •Urinary tract infection.
  • •Family history of genito-urinary tract cancer.
  • •Diabetes mellitus.

研究组 & 干预措施

Group (A) (Control group)

Active Comparator

consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.

干预措施: pelvic floor exercises, nutritional instructions (Other)

Group (B) (Study group)

Experimental

consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.

干预措施: abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions (Other)

结局指标

主要结局

Assessment of urine loss

时间窗: 24 hours pad test for12 weeks

Pad testing will be used to quantify the volume of urine loss by weighing an absorbent pad before and after some type of leakage provocation. The test will start with weighting clean empty pad in grams. Then, it will be used until next time and weighted again. The weight of the used pad will be subtracted from the weight of the empty pad so the net result will determine the amount of leakage.

assesment of pelvic floor muscle contraction and tonning

时间窗: 12 weeks

The measurements will be taken in crock-lying position with a full bladder, neutral lumbar spine. The ultrasound transducer will be inserted transversely directly superior to the symphysis pubis, probe is tilted 60 degrees from vertical (Arab, 2010). Every female will perform 3 maximal PFM contractions so that displacement of the bladder wall, because of a PFM contraction, could be measured.

次要结局

  • Assessment of symptoms and health related quality of life(12 weeks)

研究者

发起方
Badr University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Saeed Mohamed

lecturer

Badr University

研究点 (1)

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