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临床试验/CTRI/2024/04/066087
CTRI/2024/04/066087尚未招募4 期

A randomized controlled trial of periodically supervised pelvic floor muscle training versus unsupervised pelvic floor muscle training in comprehensive management of stress urinary incontinence.

Sri Manakula Vinayagar Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the effectiveness of periodically supervised pelvic floor muscle training with unsupervised pelvic floor muscle training in comprehensive management of stress urinary incontinence.

研究概览

简要总结

Stress Urinary Incontinence (SUI) is defined as an involuntary loss of urine occurring  as a result of raised intra abdominal pressure due to an exertion or on sneezing or coughing. The prevalence of stress urinary incontinence in the female population ranges from 10-40%. It is a long way to make the patients and society to get aware of stress urinary incontinence and it should be treated.Stress urinary incontinence has significant impact on women’s mental health, which leads to depression, anxiety, poor quality of life, low self-esteem, issues related to relationships which affects sexual life and reduced workplace productivity.Pelvic floor muscle training is the first line management of uncomplicated stress urinary incontinence. Performing pelvic floor muscle training with adequate training and frequency is an important factor for better outcome. About 30% of women cannot correctly identify the muscle to be contracted. Hence if biofeedback with perineometer could significantly decrease urine leakage and if improves the pelvic floor muscle strength, Pelvic floor muscle training with biofeedback may become first line of management.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • Female more than 18 years, whose stress score is more than 4 based on Questionnaire on urinary incontinence Diagnosis (QUID) able to contract the pelvic floor muscle.

排除标准

  • 2nd and 3rd degree UV prolapse Presence of Recurrent UTI urge urinary incontinence Pregnant women Chronic Respiratory Disorders Constipation Central or peripheral neuropathies Smoking H/o previous surgeries of SUI H/o previous pelvic surgery Presence of other voiding symptoms Patient on Diuretics Patient on drugs which are influencing the function of bladder and urethra.
  • Palpable pelvic pathology.

结局指标

主要结局

To compare the effectiveness of periodically supervised pelvic floor muscle training with unsupervised pelvic floor muscle training in comprehensive management of stress urinary incontinence.

时间窗: In both the groups | at 0 week - pelvic floor muscle strength that is contraction pressure is checked using perineometer | at 12th week - pelvic floor muscle strength that is contraction pressure is again rechecked and compared between both the groups

次要结局

  • To compare the improvement in pelvic floor muscle strength & quality of life between both groups

研究者

发起方
Sri Manakula Vinayagar Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Arulmozhi P

Sri Manakula Vinayagar Medical College and Hospital

研究点 (1)

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