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临床试验/CTRI/2024/09/073363
CTRI/2024/09/073363尚未招募不适用

Efficacy of Palashadi taila Yoni pichu with Moolabandha yoga therapy in women with Pelvic floor muscle weakness” – An open label clinical trial

Dr Janhavi Jadhav1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1 Perineometer for assessing vaginal wall pressure

研究概览

简要总结

Pelvic floor muscle weakness is a common condition that results in pelvic floor dysfunction having a serious negative impact on women’s lives presenting with a series of symptoms covering different degrees of pelvic organ prolapse, urinary incontinence, sexual dysfunction, fecal incontinence, chronic pelvic pain, etc which can present separately or co-exist.

Reduced pelvic floor strength is seen in women who experienced vaginal delivery and had episiotomy or instrument or traumatic delivery. Vaginal deliveries can cause morphological alterations along with levator ani muscle injuries in 13-36% of women increasing the risk of urinary incontinence and uterine prolapse.

57.7% of women were identified to have the risk of pelvic floor dysfunction. Studies have shown 93.2% of women reported pelvic pain followed by 82.4% having urinary incontinence and 1.4% had reported pelvic organ prolapse.

According to a study done in Karnataka state, the prevalence was reported to be 21%, with 19.02% of women experiencing urinary incontinence and 1.99% having pelvic organ prolapse. Studies have shown an increasing prevalence rate of such conditions in developing countries like India.

Women’s sexual health is affected by many factors which include pregnancy and childbirth along with biological, psychological, and social changes in women’s bodies which affect quality of life and sexual function. Severe perineal trauma has shown effects on sexual functions according to studies done.

Urinary incontinence is defined as ‘’the complaint of any involuntary urine leakage’’ by the International Continence Society (ICS). The prevalence of urinary incontinence among women ranges from 25% to 45% according to previous studies. Pregnancy, labor, vaginal delivery, and other surgeries are predominant contributing factors.

Compared to vaginal delivery, C- section is also not completely protective.

Women after experiencing these symptoms are hesitant to seek medical care due to lack of awareness or embarrassment. Targeted educational interventions that empower women to prioritize their pelvic health are needed so that women feel more comfortable in discussing their symptoms and seeking appropriate care.

Due to the reasons mentioned earlier, its implication in public health, and its far-reaching benefits for the overall well-being of women and to improve the quality of life of women this research work has been taken.

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
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1 Primi para and multi para 2 Delivered by C-section or vaginal delivery or forceps or vacuum delivery or any traumatic labor 3 1st degree or 2nd degree uterine prolapse 4 Women accomplishing the diagnostic criteria 5 Willing to participate.

排除标准

  • 1 Women who have undergone surgery for the pelvis and have sling or surgery for prolapse or have malignancy of pelvic organs 2 Stress urinary incontinence with a history of UTI 3 Systemically confirmed clinical diseases such as neurological conditions cardiac insufficiency and other major systemic diseases 4 Women with faecal incontinence 5 Women with a history of cystocele enterocele rectocele urethrocele omentocele 6 If the patient conceives during treatment it will be considered as dropout.

结局指标

主要结局

1 Perineometer for assessing vaginal wall pressure

时间窗: Baseline | 61th day

2 Modified Oxford Scale by vaginal digital palpation

时间窗: Baseline | 61th day

3 PERFECT Score for evaluation of contractility of PFM

时间窗: Baseline | 61th day

次要结局

  • 1 The pelvic floor distress Inventory Questionnaires 20 which is designed to evaluate what extent the lower urinary tract gastrointestinal tract and pelvic organ prolapse symptoms affect the quality of life(2 The Female sexual dysfunction Index FSFI 6 is a questionnaire validated for clinical evaluation of female sexual dysfunction in six terms)

研究者

发起方
Dr Janhavi Jadhav
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Dr Janhavi Vishwas Jadhav

KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka India

研究点 (1)

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