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CTRI Number  CTRI/2023/03/050779 [Registered on: 17/03/2023] Trial Registered Prospectively
Last Modified On: 26/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of hip muscles exercises combining with pelvic floor exercise in treating urinary incontinence after menopause in women 
Scientific Title of Study   “Effectiveness of hip muscles strengthening with kegels exercise in treatment of stress urinary incontinence among postmenopausal women: 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  DR DIKSHA GHADSE 
Designation  POSTGRADUATE STUDENT 
Affiliation  MGM INSTITUTE OF PHYSIOTHERAPY 
Address  DEPARTMENT OF COMMUNITY PHYSIOTHERAPY, MGM INSTITUTE OF PHYSIOTHERAPY, 3RD FLOOR, C BUILDING, MGM CAMPUS,
N6 CIDCO, AURANGABAD, MAHARASHTRA, INDIA- 431003
Aurangabad
MAHARASHTRA
431003
India 
Phone  07038507924  
Fax    
Email  dikshapghadse96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DOSS PRAKASH S 
Designation  PROFESSOR 
Affiliation  MGM INSTITUTE OF PHYSIOTHERAPY  
Address  DEPARTMENT OF COMMUNITY PHYSIOTHERAPY MGM INSTITUTE OF PHYSIOTHERAPY
3RD FLOOR C BUILDING MGM CAMPUS, N6 CIDCO AURANGABAD MAHARASHTRA, INDIA - 431003
Aurangabad
MAHARASHTRA
431003
India 
Phone  09886386726  
Fax    
Email  dossprakashs@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR DOSS PRAKASH S 
Designation  PROFESSOR 
Affiliation  HOD, COMMUNITY DEPARTMENT 
Address  DEPARTMENT OF COMMUNITY PHYSIOTHERAPY, MGM INSTITUTE OF PHYSIOTHERAPY,
3RD FLOOR, C BUILDING, MGM CAMPUS, N6 CIDCO, AURANGABAD, MAHARASHTRA, INDIA- 431003
Aurangabad
MAHARASHTRA
431003
India 
Phone  09886386726  
Fax    
Email  dossprakashs@gmail.com  
 
Source of Monetary or Material Support  
MGM INSTITUTE OF PHYSIOTHERAPY 
 
Primary Sponsor  
Name  MGM INSTITUTE OF PHYSIOTHERAPY 
Address  N6 CIDCO, AURANGABAD 431003 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Diksha Ghadse  MGM INSTITUTE OF PHYSIOTHERAPY  Department of Community Physiotherapy OPD, MGM INSTITUTE OF PHYSIOTHERAPY, 3RD FLOOR, C BUILDING, MGM CAMPUS, N6 CIDCO, AURANGABAD- 431003
Aurangabad
MAHARASHTRA 		 07038507924

dikshapghadse96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM INSTITUE OF PHYSIOTHERAPY- MGM INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Treatment Group- Kegels  Participants will be given Kegel’s only in Group A. The exercises for strengthening the pelvic floor muscles will be 10 contractions of 5 seconds, 15 contractions of 3 seconds, 20 contractions of 2 seconds, 20 contractions of 1 second (equal rest time between contractions), and 5 repetitions of maximum contractions while coughing (1-minute interval). The level of difficulty of the exercises throughout the 20 sessions will be determined by the patient’s position, starting in a supine position, then progressing to a sitting position and, finally, to a standing position. These changes in posture will be executed partially in five sessions, that is, some of the exercises will be done in a new position and the remaining ones in the previous posture. Changes in posture affect the difficulty of the exercises: the vertical action of gravity on the pelvic floor is absent in the supine position, present in the PFM with weight load partially reduced in the sitting position, and present with total weight load in the standing position. 
Intervention  Effectiveness of hip muscles strengthening with kegels exercise in treatment of stress urinary incontinence among postmenopausal women: A Randomized Controlled Trial  Participants will be given Hip muscles strengthening along with Kegel’s in Group B. The same exercises as those described for the conventional treatment group (Kegels exercises) will be performed during the first 20 minutes. After that, the KHG group will perform exercises for strengthening hip adductor, gluteus medius and maximus muscles for approximately 20 minutes, completing 40 minutes of session. The exercises for the hip muscles will be completely isolated from the Kegels exercises and will follow a protocol based on recommendations by the American College of Sports Medicine, with adjustments made to suit the profile of the women in this study. Four strengthening exercises will be selected—2 for the adductor muscles of the hip and 2 for the gluteal muscles: • Gluteus medius exercise. The participant positioned in lateral decubitus, with internal hip rotation, and carried out hip abduction with 90° knee flexion. • Gluteus medius and gluteus maximus exercise. The participant will stand on 1 leg, with the foot on the edge of a 10-inch-high step, and squatted slowly to lower the heel of the other foot toward the floor. • Hip adductor muscles, first exercise. The participant will be in lateral decubitus and perform hip adduction movement, maintaining the hip and knee in an extended position. • Hip adductor muscles, second exercise. The participant will be in a standing position and perform hip adduction movement and progressed with weight cuffs. In each session, the exercises will be only for the hip adductor muscles or only for the gluteal muscles. In the isometric phase of the treatment, only 1 exercise will be done for each muscle group. In the concentric phase of the treatment, the load for hip exercises will be increased every 5 sessions over 4 phases: isometric exercise without load (20 seconds of contraction, interval of 20 seconds, and ten repetitions), concentric exercise (3 sets of 10 repetitions, 1-minute break between sets) with 1 kg, concentric exercise with 2 kg, and concentric exercise with 3 kg. In the first session only Kegels will be performed because participants will learn how to perform Kegels correctly. All participants followed the same protocol. This protocol will be carried out for 8weeks till 16th session, after that patient will carry out same protocol till 1 month and after that follow up is done.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Female patients with medical diagnosis of stress urinary incontinence among postmenopausal women
2. LMP atleast 12months ago
 
 
ExclusionCriteria 
Details  1. Anti-incontinence or pelvic organ prolapse surgery history
2. Active urinary tract or vaginal infection,
3. Post-partum incontinence issues till 1 year
4. Pregnancy, post-void residual volume>100 ml
5. Pelvic organ prolapse>Grade 2,
6. Presence of comorbidities that affect the lower urinary tract, such as neurological disease, diabetes mellitus, psychiatric disease or renal failure.
7. Current hormone replacement therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Symptom and QoL Evaluation   10 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Pelvic Floor Function and Muscle Strength:  10mins 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Objectives

1.     To determine the effectiveness of kegel’s exercises on frequency, strength and QOL in stress urinary incontinence among postmenopausal women

2.     To determine the effectiveness of kegel’s exercises combined with hip muscles strengthening on frequency, strength and QOL in treatment of stress urinary incontinence among postmenopausal women

3. To compare the effectiveness of hip muscles strengthening on frequency, strength and QOL in treatment of stress urinary incontinence among postmenopausal women


Study design: Randomized Control Trial

Study setting: Tertiary Hospitals, Outreach Programs, PHC

Procedure:  Female patients with stress urinary incontinence in the age of 45-70 years of age will be taken. Eligible participants will be included for the study. Before collection of the data, Informed written and verbal consent will be taken from all the participants. The subjects will be interviewed and the information gathered about their demographic data of patients including name, age, gender, occupation, any history of systemic diseases and medications will be documented. Demographic data will be collected and 2 evaluations carried out, 1 at the beginning of the treatment and the other after 16 sessions of physical therapy intervention. Also after 1month till 20th session, follow up will be taken.


Conventional Treatment Group: 

Participants will be given Kegel’s only in Group A. 

Intervention Group

Participants will be given Hip muscles strengthening along with Kegel’s in Group B. The same exercises as those described for the conventional treatment group (Kegels exercises) will be performed during the first 20 minutes. After that, the KHG group will perform exercises for strengthening hip adductor, gluteus medius and maximus muscles for approximately 20 minutes, completing 40 minutes of session. The exercises for the hip muscles will be completely isolated from the Kegels exercises and will follow a protocol based on recommendations by the American College of Sports Medicine, with adjustments made to suit the profile of the women in this study.



 
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