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临床试验/CTRI/2025/07/091538
CTRI/2025/07/091538Not Applicable2 期

Effectiveness of Ultrasound-guided Pelvic-floor exercise on incontinence severity, Post-void residual volume and Frequency of urinary tract infection for Women with Stress urinary incontinence.

Nupur Akter1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
2 期
状态
Not Applicable
发起方
入组人数
220
试验地点
1
主要终点
Incontinence severity

研究概览

简要总结

An eight-week randomized clinical trial will evaluate the effectiveness of ultrasound-guided pelvic-floor exercise (PFE) in women with stress urinary incontinence (SUI). A total of 220 women aged 18–65 years (110 per group) will be recruited. Participants will be randomly assigned to either an ultrasound-guided PFE group or a control group performing the same exercises without ultrasound guidance. Both groups will attend two 45-minute sessions per week for eight weeks. The primary outcomes are urine leakage (measured by a 1-hour pad test) and post-void residual (PVR) volume assessed via ultrasound. Secondary outcomes include urinary tract infection (UTI) indicators such as pus cells and other urinary components. Women with pregnancy, recent postpartum status, pelvic surgery history, or other medical exclusions will not be included. The trial aims to determine if real-time ultrasound biofeedback improves exercise effectiveness in managing SUI symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Parous (Given birth to 1 child).
  • Nulliparous (Never given birth).
  • Diagnosed as Urinary Tract Infection and Stress Urinary Incontinence.
  • BMI of 18–30 kg/m2.

排除标准

  • Pregnant or gave birth in the past six months.
  • History of pelvic surgery.
  • Chronic respiratory diseases.
  • Use of medications for Urinary Tract Infection.
  • Cardiac pacemaker implanted.
  • Psychological disorders.

结局指标

主要结局

Incontinence severity

时间窗: 2 Months

次要结局

  • Frequency of urinary tract infection(2 Months)

研究者

发起方
Nupur Akter
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Nupur Akter

Jashore University of Science and Technology (JUST)

研究点 (1)

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