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临床试验/CTRI/2025/12/099596
CTRI/2025/12/099596尚未招募不适用

Impact of 6 week multimodal intervention program in managing hypotonic pelvic floor dysfunction among post menopausal women- a randomised control trial

SGT University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1

研究概览

简要总结

**NEED OF THE STUDY:**There is a growing need to address pelvic health concerns in postmenopausal women, as hormonal changes during menopause significantly impact pelvic floor function, leading to issues such as urinary incontinence, pelvic organ prolapse, and sexual dysfunction. Despite the high prevalence and negative impact of these conditions on women’s quality of life, they are often overlooked or inadequately managed, largely due to social stigma, lack of awareness, and limited access to effective, non-surgical treatment options. While individual interventions such as pelvic floor exercises or lifestyle modifications have shown benefits, there is limited evidence on the effectiveness of multimodal intervention programs that combine several therapeutic strategies for a more holistic approach. A well-designed randomized controlled trial is necessary to evaluate the comprehensive benefits of such programs, providing strong clinical evidence to guide practice. By addressing this gap, the study can contribute to the development of more effective, accessible, and preventive healthcare strategies for postmenopausal women, ultimately improving their long-term physical and psychological well-being.

**SIGNIFICANCE OF THE STUDY:**The significance of this study lies in its potential to improve the management of pelvic health in postmenopausal women, a population often affected by pelvic floor dysfunctions such as urinary incontinence, pelvic organ prolapses, and sexual dysfunction. These conditions, though common, are frequently underreported and inadequately addressed, leading to a diminished quality of life. By evaluating the impact of a multimodal intervention program—which may include pelvic floor muscle training, physical therapy, lifestyle modification, and health education—this randomized controlled trial offers a non-invasive, cost-effective alternative to pharmacological or surgical treatments. The study addresses a critical gap in the literature by providing high-quality evidence on the effectiveness of a comprehensive approach specifically tailored for postmenopausal women. Furthermore, it has the potential to influence clinical guidelines, support the development of preventive care strategies, and promote awareness and empowerment among women regarding pelvic health. Ultimately, the findings may lead to improved physical, emotional, and social well-being for a large and often underserved segment of the female population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • 1.45-65 years old women 2.Clinical diagnosis or self-reported symptom of pelvic floor dysfunction.

排除标准

  • 1.Urinary tract infection 2.Any neurological disorder 3.Recent Pelvic or abdominal surgery 4.Constipation 5.Pelvic malignancy.

研究者

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

Annanya Verma

SGT University

研究点 (1)

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