Effect of Medical Yoga therapy along with Pelvic Floor Muscle Training (PFMT) for Stress Urinary Incontinence (SUI) women attending tertiary care hospital OPD, West Bengal.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Average frequency of stress urinary incontinence episodes using validated 3-days voiding diary.
研究概览
简要总结
Problem statement: Effect of Medical Yoga therapy along with Pelvic Floor Muscle Training (PFMT) for Stress Urinary Incontinence (SUI) women attending tertiary care hospital OPD, West Bengal**.**
Objectives:
a. Primary objective: To evaluate Effect of adding Medical yoga to Floor Muscle Training (PFMT) to treat Stress Urinary Incontinence (SUI) among women attending urology OPD.
b. Secondary objectives:
I. To assess impact of stress incontinence on quality of life.
II. To find the association between symptoms score and selected demographic variables.
Research hypothesis:
**H1:**Effect of Yoga with PFMT will have significant effect on Stress Urinary Incontinence symptom score than only PFMT.
H0: Effect of Yoga with PFMT will not have significant effect on Stress Urinary Incontinence symptom score than only PFMT.
Timelines: Total duration is 3 years.
Study participants: Stress Urinary Incontinence (SUI) affected women.
Study design: Parallel open label randomized active controlled trial
Number of groups to be studied, their names and definitions: Two group- Experimental (receiving PFMT and Yoga) and control group (receiving only PFMT).
Population**:** Stress Urinary Incontinence (SUI) affected women.
Sample: Stress Urinary Incontinence (SUI) affected women attending urology OPD in selected tertiary care hospital.
Sampling method: Permuted block randomization, Fixed.
Sample size**:** 200 in total and divided into two equal arm (Intervention group 100 and control group 100).
List of variables: Demographic variables and clinical profile, incontinence-related Quality Of Life, Frequency and volume.
Data collection tools: Structured questionnaire on Demographic variables and clinical profile, ICIQ-UI SF(International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence) Short Form to assess quality of life, ICIQ
(International Consultation on Incontinence Modular Questionnaire) Bladder Diary to measure urinary frequency.Final Study setting: OPD of SSKM Hospital
Self-funded study
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 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Ambulatory women with the age group between 18 yrs to 60 yrs.
- •History of involuntary loss of urine for at least 3 months that is a social or hygienic problem.
- •Documented for minimum 3 episodes of incontinence on a screening 3-day voiding diary.
- •Participants also agreed to be refrain from other treatment related to incontinence during the trial period.
- •Positive cough stress test.
- •Women residing within 100 km in radius.
- •History of stress urinary incontinence according to International Continence Society (ICS).
- •Urine leakage >4gm measured by pad test with standardized bladder volume.
- •Willing to give consent for participation in study.
- •They must be motivated to undertake yoga exercises if required.
- •Understands English/Hindi/Bengali.
排除标准
- •The women will be excluded if they, I.
- •Severe mobility limitation that would prevent from participating in yoga session.
- •Eg. Inability to walk two blocks on level ground or unassisted getting up from supine to standing position within 10 seconds or inability to walk up a single stair.
- •Participants did not use practitioner-supervised pharmacological or clinical treatments for last 3 months.
- •Woman with UI having any of the following symptom’s pain or hematuria (assessed by urine dipstick testing), recurrent infections, interstitial cystitis or chronic pelvic pain, suspected or proven voiding problems, or significant pelvic organ prolapse.
- •Abnormal bladder function (residual urine>50 ml and maximal uroflow <15ml/s).
- •Women who had delivered a baby in last 6 months.
- •Women suffering from pelvic malignancy, h/o radical surgery and/or irradiation or anti-incontinent surgery/urethral surgery/or pelvic surgery.
- •Women with neurological or psychiatric disorders, uncontrolled diabetes mellitus.
结局指标
主要结局
Average frequency of stress urinary incontinence episodes using validated 3-days voiding diary.
时间窗: Baseline, 4 weeks, 8 weeks.
次要结局
- 1. Changes in the frequency of stress incontinence, any daytime incontinence, night-time incontinence, daytime voids in toilet, nighttime voids in toilet assessed by 3 days voiding diary.(2. Quality of life as measured by ICIQ-UI SF (International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence) Short Form.)
- 1.Cough stress test(2. Pad test)
研究者
Mala Bhowmik
IPGMER and SSKM Hospital