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临床试验/CTRI/2026/01/102598
CTRI/2026/01/102598尚未招募1 期

The Efficacy Of Behavioral Therapy In The Treatment Of Stress Urinary Incontinence In Middle Aged Women

RoshiniR1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月10日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
ICIQ-UI SF score reduction and Pelvic floor muscle strength (PERFECT)

研究概览

简要总结

Stress urinary incontinence (SUI) which is involuntary urine loss or leakage during exercise, getting up from lying down, coughing or sneezing.  Stress urinary incontinence is considered to be the most common type of incontinence in middle-aged women. Women undergo anatomical and neuromuscular changes and injury during childbirth, which decreases pelvic floor muscle (PFM) strength. The resulting loss of muscular strength combined with the lack of tissue resilience prohibits support of the bladder neck during physical stress and results in leakage. Some women might not experience incontinence until a small loss of pelvic floor muscle strength occurs within the normal aging process – particularly after menopause, through other injuries, or through some medications that might induce incontinence.

The majority of exercise protocols targeted pelvic floor muscle properties and integration of exercises into activities of daily living.  Most of the patients do not effectively recruit their pelvic floor muscles while performing Kegels and require a therapist supervision. Sung Tae Chol et.al. (2021) stated that PFMT (Kegels) was the most effective when performed under the supervision of a therapist with a biofeedback device to improve PFM strength in adult women with SUI . Alime Buyuk1 et.al. (2021) observed that Pelvic floor muscle training (PFMT) and Behavioral training ( BT) reduced the symptom severity of pelvic floor dysfunction in elderly subjects.

Behavioral Training (BT) actively engage the patient for changing habits or learning new skills. These interventions had to address low risk , affordable and accessible lifestyle and behavioral intervention can used to treat urinary incontinence. It consists of techniques that aim to reduce or even eliminate incontinence symptoms, through education about the condition, changes in lifestyle and bladder training. It involves the patient’s perception of their own body and health conditions, requiring adjustments related to habits and behaviors. The changes include weight loss, avoiding some foods or beverages that are harmful to the bladder, regulation of intestinal function, drinking water correctly, and also a scheduled voiding regimen can reduce urinary symptoms.

This study aims to evaluate the effects of Behavioral Training (BT) on severity of stress urinary incontinence symptoms and Pelvic floor muscle strength among middle aged women.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 59.00 Year(s)(—)
性别
Female

入选标准

  • Women between the aged 45–59 years of age.
  • Clinically diagnosed with stress urinary incontinence Not currently engaged in any pelvic floor rehabilitation program.
  • Women who give willingness to participate in the study.
  • Able to understand and follow verbal commands or instructions.

排除标准

  • Mixed or urge urinary incontinence Pregnancy or postpartum (within 6 months).
  • Women with severe cardiovascular problems, neurological issues, severe musculoskeletal problems Neurological conditions affecting bladder control (e.g., multiple sclerosis, spinal cord injury).
  • Those with pelvic organ malignancy, undergoing radical surgery for pelvis, sling or prolapse surgery.

结局指标

主要结局

ICIQ-UI SF score reduction and Pelvic floor muscle strength (PERFECT)

时间窗: 6 months

次要结局

  • Qol Adherence Subjective improvement & group comparisons(6 months)

研究者

发起方
RoshiniR
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Roshini R

Sri Ramachandra Institute Of Higher Education And Research

研究点 (1)

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