Efficacy of Transvaginal Pelvic Floor Muscle Training on Strength & Endurance of Pelvic Floor Muscles & Quality of Life in Peri & Post Menopausal Females with Stress Urinary Incontinence – A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1. Strength of Pelvic Floor Muscles
研究概览
简要总结
Post Menopausal Females with Stress Urinary Incontinence , aged between 44-55 Years will be randomized by computer-based randomization into 3 groups and will be treated with Pelvic Floor Muscle Training PFMT ( Group A: Transvaginal PFMT , Group B: Supervised PFMT, Group C: Unsupervised PFMT, Home Program)
The objectives of the present study will be:
1. To find the effect of Transvaginal Pelvic Floor Muscle Training on Strength , Endurance of PFM & QoL in peri & post-menopausal middle-aged women with stress urinary incontinence
2. To find the effect of Supervised Pelvic Floor Muscle Training on Strength , Endurance of PFM & QoL in peri & post-menopausal middle-aged women with stress urinary incontinence
3. To find the effect of Unsupervised Pelvic Floor Muscle Training on Strength , Endurance of PFM & QoL in peri & post-menopausal middle-aged women with stress urinary incontinence
4. To compare the Effect of Transvaginal PFMT, Supervised PFMT & Non-supervised PFMT on Strength , Endurance of PFM & QoL in peri & post-menopausal middle-aged women with stress urinary incontinence
Materials & Methods
• All patients will be screened, will be informed about the study
• Patients’ initial evaluation will include medical, gynaecological and incontinence-specific history,
• Trans vaginal assessment of the pelvic floor muscles according to the Oxford scale, PERFECT Scale will be done & Incontinence Quality of Life Questionnaire.
• Study will be conducted in Department of Physiotherapy, ABVIMS & Dr. Ram Manohar Lohia Hospital, New Delhi
• Study Design: Randomised Controlled Study
• Sampling: Convenience Sampling; Randomisation will be done by Computerised Generated Process.
• Informed consent from patients & Approval from hospital research ethics committee will be taken
Methodology
Peri / Post Menopausal Females, Age 44 – 55, N = 123, will be Assessed for Eligibility as Per Inclusion & Exclusion Criteria
Group A , INTERVENTION GROUP ; TRANSVAGINAL PFM (N=41) , Group B interventional GROUP, SUPERVISED GROUP SESSIONS PFM (N=41), GROUP C, UNSUPERVISED, HOME PROG PFM (N=41)
ASSESSEMENT WILL BE DONE WITH OXFORD & PERFECT SCALE, which are transvaginal digital palpation methods where with the help of distal pad of index finger Pelvic Floor Muscles are assessed to detect any changes in resting tone, identify areas of atrophy & differentiate between state of contraction & relaxation. Following parameters will be recorded:
1. POWER (P) = STRENGTHOF PFM (OXFORD SCALE)
2. ENDURANCE (E) sec
3. NO OF REPETETIONS ( R ) WITH ENDURANCE E
4. NO OF FAST TWITCH CONTRACTIONS (F)
5. QUALITY OF LIFE
TREATMENT WILL BE GIVEN TO ALL 3 GROUPS AS PER THE PROTOCOL, 2 SESSIONS /WEEK FOR 3 CONSECUTIVE MONTHS–> 1ST MONTH PFM IN SUPINE LYING, 2ND MONTH PFM IN SITTING, 3RD MONTH PFM IN LYING
Patient would be instructed to practice (R) Repetitions of her strongest contractions with Power (P) lasting Endurance of (E) seconds (with 4 seconds rest between) at each exercise session, and fast (F) strong contractions at other times. X 3 sets ; Patient will aim to increase the number of repetitions of the long MVC over subsequent weeks up to 10 repetitions. X 3 sets
In view of weak PFM, assessing the number of Fast Contractions would be confusing; & should be done at a later date when endurance improved to 4 seconds. Treatment should progress in the first instance by aiming to hold the contractions for 3 (then4) seconds. Once this is achieved, strength should be addressed & patient encouraged to contract harder. Once a grade 3 is achieved, endurance is once again addressed and subject encouraged to increase the length of contraction.
After this, over the succeeding weeks, treatment will aim to increase the hold time to 10 seconds. In addition, the number of fast contractions should be progressively increased to the maximum number possible (many patients can do up to 50 fast contractions). The aim is to be able to perform 10 repetitions of a 10-second MVC at regular intervals during the day, and 10+ fast contractions at other times during the day. Equal numbers of sessions of slow and fast contractions are encouraged, up to six per day
REASSESSMENT WILL BE DONE AFTER EACH 1 MONTH FOR 3 CONSECUTIVE MONTHS (IN ALL 3 GROUPS)
APPROPRIATE STATISTICAL ANALYSIS & COMPARISON OF RESULTS WILL BE DONE.
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
- 44.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Middle aged Peri/ Post Menopausal women (age 44 – 55 years) with clinical diagnosis of SUI for more than 3 months and/or Mixed UI with predominant SUI symptoms, having sufficient cognitive and physical function to allow them to participate in the program.
- •Min 3 incontinence episodes per week, daytime frequency of less than 8 micturition episodes, nocturia of less than 3 episodes, positive stress test (urine leakage with coughing)
- •3 on Oxford scale / PERFECT Scale .
- •Patients with mild to moderate stress urinary incontinence (Garde 1 / Grade2).
排除标准
- •Symptoms primarily of urge incontinence
- •Presence of any degree of pelvic organ prolapse above grade 1
- •Cognitive, Neurological, psychiatric and/or physical disorders that could hinder their participation in the assessment & Treatment
- •Use of medications affecting micturition/ presence of current UTI
- •History of surgical or pharmaceutical treatment of SUI,
- •Chronic debilitating disease such as renal failure
- •Patients with oncology treatment.
- •Inability to contract the PFM (grade zero according to the Modified Oxford Grading Scale)
- •Previous pelvic floor surgeries
- •Women with instrumental deliveries/ nulliparous women/ multiparous women with parity above 3
- •Inability to contract the PFMs (grade zero according to the Modified Oxford Grading Scale).
结局指标
主要结局
1. Strength of Pelvic Floor Muscles
时间窗: 1. Baseline | 2. 4 weeks | 3. 8 weeks | 4. 12 weeks
2. Endurance of Pelvic Floor Muscles
时间窗: 1. Baseline | 2. 4 weeks | 3. 8 weeks | 4. 12 weeks
3. Number of Fast Twitch Contractions of Pelvic Floor Muscles
时间窗: 1. Baseline | 2. 4 weeks | 3. 8 weeks | 4. 12 weeks
4. Number of Full-Strength Repetitions of Pelvic Floor Muscles Contractions
时间窗: 1. Baseline | 2. 4 weeks | 3. 8 weeks | 4. 12 weeks
次要结局
- Quality Of Life Questionnaire (Incontinence related)(1. Baseline)
研究者
Prof Dr Shagun Aggarwal
School of Allied Health Sciences, Galgotias University