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CTRI Number  CTRI/2023/05/052395 [Registered on: 09/05/2023] Trial Registered Prospectively
Last Modified On: 08/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECT OF PELVIC FLOOR MUSCLE TRAINING AND STRENGTHENING OF HIP MUSCLES IN STRESS URINARY INCONTINENCE 
Scientific Title of Study   EFFECTIVENESS OF PELVIC FLOOR MUSCLE TRAINING AND PROGRESSIVE RESISTED EXERCISES OF HIP MUSCLES IN STRESS URINARY INCONTINENECE - A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonali Asolkar 
Designation  Post Graduate Student 
Affiliation  Pravara Institute Of Medical Sciences 
Address  Dr APJ ABDUL KALAM college of physiotherapy Pravara Institute of Medical Sciences Loni. Community Physiotherapy Department, 404

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9767559680  
Fax    
Email  sonaliasolkar217@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepali Hande 
Designation  Head Of Department, Community Physiotherapy 
Affiliation  Pravara Institute Of Medical Sciences 
Address  Dr APJ ABDUL KALAM college of physiotherapy Pravara Institute of Medical Sciences Loni. Community Physiotherapy Department, 404

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8275034001  
Fax    
Email  deepalihande28@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sonali Asolkar 
Designation  Post Graduate Student 
Affiliation  Pravara Institute Of Medical Sciences 
Address  Dr APJ ABDUL KALAM college of physiotherapy Pravara Institute of Medical Sciences Loni. Community Physiotherapy Department, 404

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9767559680  
Fax    
Email  sonaliasolkar217@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. APJ Abdul Kalam College of Physiotherapy 
Address  Dr. APJ Abdul Kalam College of Physiotherapy, loni,Ahmadnagar 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sonali Asolkar  Pravara Rural Hospital  Department of Community Physiotherapy
Ahmadnagar
MAHARASHTRA 
9767559680

sonaliasolkar217@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee of Dr. APJ Abdul Kalam COPT  Approved 
Institutional Ethical Committee PMT Loni  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pelvic Floor Muscle Training  The pelvic floor muscle training was given in three positions: supine position, sitting position, standing position. 1-2session: supine position 3-4session: supine + sitting position 5-6session: sitting + standing position 7-8session: standing position   Contractions given- 10 contractions of 5 seconds 15 contractions of 3 seconds 20 contractions of 1seconds   5 contractions while coughing 1st session: participants received verbal instructions about the correct contractions of pelvic floor muscle, which should be in cranial direction and performed without contracting adjacent muscles such as abdominal muscles, hip adductors or gluteal muscles. 8 Weeks 
Intervention  Pelvic floor muscle training and Progressive Resisted Exercises Of Hip Muscles  progressive resisted exercises of hip muscles such as gluteus medius, maximus, and hip adductor muscles approximately 25 minutes will performed. 4 strengthening exercises were given- 2 for adductor muscles of hip 2 for gluteal muscles of hip 1.Gluteus medius exercises: The participant was positioned in side lying position, with internal hip rotation, and carried out hip abduction with 900 knee flexion. 2. Gluteus medius and gluteus maximus muscle: The participant stood on one leg, with the foot on the edge of a 10 inch high step, slowly lower the heel of the other foot to the floor.   3.Hip adductor(1st exercise): Participants in side lying position and performed hip adduction movement, maintaining hip and knee in an extended position.   4. Hip adductor (2nd exercise): Participant in standing position, and performed hip adduction movement against weight to the midline of the body.   Beginning with concentric phase,1 muscle group per session with 2 exercises (3 sets of 10 reps.) 8 Weeks    
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Participants suffering from stress urinary
incontinence
2.Participants between the age group of 35 to 60
years
3.Medical diagnosis of stress urinary
incontinence by Obstetrics and Gynaecology
department
4.Those willing to participate in the study
5.Participants who are able to understand the
commands

 
 
ExclusionCriteria 
Details  1.Diagnosis of neurological or muscular disease
that interferes with the function of urinary
incontinence
2.Active or recurrent infection of the
genitourinary tract
3.Gynaecological surgery for correction of
urinary incontinence
4.Current hormone replacement therapy
5.Pregnancy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of the Pelvic Floor Muscle Strength   Baseline week 0 and post at week 8 
 
Secondary Outcome  
Outcome  TimePoints 
King’s Health Questionnaire  Baseline week 0 and post at week 8 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION

Catherine Du Beau quoted that “Urinary incontinence not only causes great unhappiness but can also increase disability, social isolation, and health care costs” Urinary incontinence(UI) is defined by the International Continence Society as “a condition in which involuntary loss of urine which is objectively with such a degree of severity that it is a social and hygienic problem, and severely affecting quality of life(QoL).1 A women may present at any stage of her adult life complaining of problem associated with bowel bladder or genital function. Problems are frequently multifactorial, involving one or more components- bladder, urethral and anal smooth muscles, urethral, anal and pelvic floor striated muscles and endopelvic fascia.2

UI causes embarrassment, loss of self- confidence which may lead to urinary tract infections, pressure ulcers and diseases of the perineal skin. The medical, social, psychological and economic implications of this condition lead to changes in standard of living and negatively affect the quality of life (QoL) in women. Feelings such as loneliness, sadness and depression are present in the incontinent woman life.3 The problem is more pronounced in India where woman usually do not seek treatment for their reproductive health problems and do not vocalise their symptoms.4 Although urinary incontinence and related symptoms can have substantial impact on quality of life , relatively few woman seek help from health care professionals, leading to high levels of unmet need for incontinence services. This is mainly due to misattributions of cause such as assumptions that symptoms are normal after child birth or in older age, and to a lack of awareness of available treatment options.5 Woman that present mild or moderate incontinence levels usually do not think about taking care, and the frequency for seeking treatment increases during the postmenopausal period, when the degree of urinary loss increases.3 Woman in India also has been reported to have more patience threshold for seeking treatment because of shyness, fear of surgery, lack of money, dependency on husband and non- availability of female doctors in the periphery.6 In addition to the effect of age ,other factors associated with urinary incontinence in multiple, large, population- based studies include parity, obesity previous hysterectomy or pelvic surgery, pulmonary disease, diabetes mellitus and nursing home admission or dementia.7 They also include the risk factors for UI are chronically increased abdominal pressure, chronic cough, constipation, occupational risk, urinary symptoms, childbirth, pregnancy, menopause, functional impairment, diuretic therapy, smoking and genetics.8Globally UI affects the quality of life at least one third of the woman.6 UI is a universal health problem amongst woman, with the prevalence varying from 8-45% in different studies. This wide variation may be due to different factors such as under reporting caused by shame and the belief that it is natural consequence of aging,1 In a survey done in Asia, the prevalence of urinary incontinencein India was 12% .9 UI more common in women than in men and affects woman of all ages. Prevalence rate in woman between 15 and 64 years of age vary from 10% to 30% which increases with age.3-5The prevalence of UI is significantly higher for individuals living in nursing homes, compared to community settings, with rates ranging from 43% to 77% .10

The effective management of stress urinary incontinence (SUI) requires knowledge of the pathophysiologic mechanisms behind the disorder, so understanding the anatomy and function of the pelvic floor and its supporting structures is important to provide proper treatment to a woman.Urinary incontinence (UI) is a frequent symptom that can affect woman of all ages, with a large range of severity. Is rarely life- threatening, but may seriously have an impact on the physical, psychological and social wellbeing of affected individuals.11 It is one of the priority health issue recognized by WHO. This may occur as a result of a number of abnormalities of function of the lower urinary tract, or as a result of other illnesses, and these are likely to cause leakage in different situations.1 There are various types of Urinary Incontinence: Stress, Urge, Giggle, Mixed, Overactive bladder, Nocturnal Enuresis and more. The most common type of incontinence is Stress Urinary Incontinence (SUI) with an estimated prevalence of 8-33%. SUI is defined as the involuntary loss of urine during physical exertion, e.g. coughing, sneezing, laughing, running.1 SUI is most common type of incontinence among woman accounting for as much as 65% of all types of UI in woman. It is highest in young and middle aged group. There is a relative decrease with increasing age. History of woman with UI guides the investigation and management by evaluating symptoms, their progression and the impact of symptoms on lifestyle. Taking a history also allows the assessment of risk factors associated with the possible diagnosis. The relevant elements of history follow. A large portion of woman with urinary stress incontinence can be diagnosed from clinical history alone.1,12 The history includes the frequency, voiding symptoms, post maturation symptoms. Along with the clinical history there are also several methods used to asses UI they are Perineometer, urinary diaries, pad- tests although they are common diagnostic assessments used in physical therapy. There are also various scales to asses quality of life in patients with UI.12 The pregnancy, child birth and increase in age play a major role in developing SUI. Trupti N.  Bodhare, Sameer Valsangkar and Samir D. Bele  (2009) conducted a cross sectional descriptive study in Karimnagar, India. In a sample of 552 woman, 53 (10%) reported episodes of UI. The prevalence of UI showed significant association with increasing age (p<0.01)57% of them had stress incontinence, 23% had urge, 20 % mixed symptom of UI. The findings of recent survey on the prevalence of UI among woman show that while a third of the patients had find the lack of bladder control a definite bother, very few woman reached out for the medical assistance and even fewer of them knew which specialist to consult.13Conservative treatments, a nonsurgical therapy, it includes improving the way of living, bladder re- training, pelvic floor muscle exercises, biofeedback, vaginal cones and the electrical stimulation of pelvic muscles. Pelvic floor muscle exercises were first described as a possible treatment for urinary incontinence by Kegel’s in 1948. They are the most accepted method of reinforcing pelvic floor muscles and is a non- invasive management such that it does not involve the placement of any vaginal weights/ cones.14 The aim of pelvic floor muscle exercise is to strengthen the perivaginal and perianal musculature in order to increase a women’s control of urine leakage.15 In 1948 , Kegel’s reported that pelvic floor training produces a cure rate of 84% for woman with various types of incontinence. Rehabilitation of the pelvic floor muscle in form of Kegel’s exercises is done which helps in stabilizing the urethra by increasing the pelvic floor muscle strength. This traditional method brings about the contraction of only the pubococcygeus muscle.16,17 Fast pelvic floor muscle contraction will clamp the urethra, thereby increasing the urethral pressure and prevent urinary leakage during abrupt increase in intra –abdominal pressure. The exercise does not require any instrument and can be done anywhere. It will also improve pelvic organ support. MRI and electromyography have demonstrated that the levator ani, the fossa ischioanalis, and the gluteus maximus are morphologically and functionally connected. And that the contraction of hip adductor and gluteus muscles facilitates the synergic contraction of pelvic floor muscles and striated urethral wall muscles. Woman with stress urinary incontinence show less strength in their abductor muscles and external rotators of hip compared with woman not having urinary incontinence.18 The synergism of hip muscles may reduce symptoms of stress urinary incontinence .This has to be shown to be based on postural changes, such as crossing the legs. It has been speculated that, the hip muscles are involved in continence mechanism and that their deficiency could destabilize the normal function of system.18

Need for the study

Stress Urinary Incontinence is extremely common problem that most woman experience at some point of their life. It causes enormous impact on physical, psychological and social wellbeing of affected individuals and also decreases the self confidence in many women. There are various treatments available for Urinary Incontinence to strengthen the pelvic floor muscles that include physical therapy, behavioural modifications and pharmacological interventions. Most of the studies have concentrated on the use and the effects of Conventional Therapy for Stress Urinary Incontinence and how useful it is for Strengthening Pelvic Floor Muscles. But there are fewer studies on the effectiveness of Progressive Resisted Exercises for hip muscles in Stress Urinary Incontinence. Hence the purpose of the study is to identify the effectiveness of Progressive Resistance Exercises for hip muscles and Pelvic Floor Muscle Training on the woman suffering from Stress Urinary Incontinence.

Research Question:

Will there be any difference in the pelvic floor muscle strength and the quality of life of female participants with Stress Urinary Incontinence when treated with pelvic floor muscle training and progressive resisted exercises for the hip muscles for the period of 8 weeks?

Aim of the study:

To find out the effectiveness of pelvic floor muscle training and progressive resisted exercises for strengthening of hip muscles in Stress Urinary Incontinence.

Objectives of the study:

   To determine the effectiveness of pelvic floor muscle training and hip muscle strengthening on strength of the pelvic floor muscle.

           To determine the effectiveness of pelvic floor muscle training, progressive resisted exercises of hip muscles and quality of life on patients with Stress Urinary Incontinence.

            To compare the effectiveness of pelvic floor muscle training and progressive resisted exercises for hip muscles and quality of life on patients with Stress Urinary Incontinence

Hypotheses:

Null Hypothesis (H0):

There will be no significant difference in the pelvic floor muscle strength and quality of life of female participants with Stress Urinary Incontinence when treated with pelvic floor muscle training and progressive resisted exercises for hip muscles for the period of 8 weeks.

Alternative Hypothesis (H1):

There will be significant difference in the pelvic floor muscle strength and quality of life of female participants with Stress Urinary Incontinence when treated with pelvic floor muscle training and progressive resisted exercises for hip muscles for the period of 8 weeks.

 


 
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