Therapeutic Evaluation of Unani Formulation in Salas al-Bawl (Stress Urinary Incontinence): A Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- • Reduction in the number of incontinent episodes assessed by bladder diary.
研究概览
简要总结
Urinary incontinence (UI) is a multifactorial syndrome defined as an involuntary loss of urine[1]. Stress urinary incontinence (SUI) is an age-old problem that continues to generate great interest due to its considerable public health burden and the controversies that surround its management. It has been defined by the International Continence Society (ICS) as ‘‘the involuntary leakage of urine on exertion, or sneezing., urinary incontinence (UI) is an under-reported, undiagnosed, and often untreated medical condition that highly impacts the quality of life for women at any age[2,3]. SUI is one of the most common types of pelvic floor disorders in women.
The reported prevalence of SUI varies widely, ranging from 4.8 to 67% according to different epidemiological report. The symptoms of incontinence can severely compromise the physical, psychological, and economic well-being of individuals and their families, ultimately reducing the quality of life. Despite the high prevalence, health-seeking behaviour regarding SUI is low worldwide only 13–55 % of women with SUI symptoms seek medical care[4]. The risk factors for SUI in women are weak collagen, diabetes mellitus, advanced age, chronic obstructive airway disease, ethnicity, constipation, pregnancy and childbirth, obesity, (body mass index>30), advanced pelvic organ prolapse, hysterectomy, neurological disease, smoking, spinal cord trauma and pelvic floor injury SUI obviously requires some degree of weakness of both the proximal and distal urethral sphincter mechanisms. Symptoms are typically described as small amount of urine loss. [5]There is an increasing need for UI treatment, given the combination of ageing population and more women seeking treatment. Physical therapy is now recommended as first-line treatment for UI, with better results in relation to drug treatment and surgery.[1]
The first-line treatment for stress urinary incontinence (SUI) is pelvic floor muscle training (PFMT), with success in 60–70% of those who comply[6]. A length of at least three months is recommended for the practice of PFMT to see a major change[7]. Management strategies to reduce the burden of SUI include behavioural changes, weight reduction, pelvic floor muscle therapy (PFMT), and various surgical interventions[8]
In Unani system of medicine to treat such conditions, the renowned Unani physicians have mentioned about the use of drugs having qabiz (astringent), muqawwie dimagh (brain tonic) and muhallil (anti-inflammatory) properties. [9,10,26]. Considering this fact, it has been decided to conduct a clinical trial with polyherbal Unani formulation in the management of stress urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- ••Married women above the age group of 21-60 years.
- ••Clinically diagnosed patients of stress urinary incontinence willing to participate in the study.
排除标准
- ••Pregnant and lactating women.
- ••Patients with 3rd and 4th degree genital prolapse.
- ••H/o systemic illnesses, endocrinal diseases and malignancies.
- ••H/o any pharmacological intervention within 3 months and have had surgical intervention for SUI.
结局指标
主要结局
• Reduction in the number of incontinent episodes assessed by bladder diary.
时间窗: Baseline (0day), 15th day, 30th day, 45th day and 60th day
• Reduction in ICIQ-SF score.
时间窗: Baseline (0day), 15th day, 30th day, 45th day and 60th day
次要结局
- •Pelvic floor muscle strength assessed by Modified Oxford Grading Scale(Baseline (0day), 15th day, 30th day, 45th day and 60th day)
研究者
Dr Juveriya Naaz Bhusnur
Luqman unani medical colllege hospital and research centre bijapur
