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CTRI Number  CTRI/2025/12/099596 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
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   Impact of 6 week multimodal intervention program in managing hypotonic pelvic floor dysfunction among post menopausal women- a randomised control trial 
Scientific Title of Study   Impact of 6 week multimodal intervention program in managing hypotonic pelvic floor dysfunction among post menopausal women- a randomised control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Annanya Verma 
Designation  PG Student 
Affiliation  SGT University 
Address  SGT University, School of Physiotherapy,B block Chandu, Budhera

Gurgaon
HARYANA
122505
India 
Phone  07079011401  
Fax    
Email  annanyav35@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Rishi 
Designation  Associate Professor  
Affiliation  SGT University 
Address  SGT University, School of Physiotherapy,B block Chandu, Budhera

Gurgaon
HARYANA
122505
India 
Phone  8588878467  
Fax    
Email  Priyanka.sphy@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka Rishi 
Designation  Associate Professor  
Affiliation  SGT University 
Address  SGT University, School of Physiotherapy,B block Chandu, Budhera


HARYANA
122505
India 
Phone  8588878467  
Fax    
Email  Priyanka.sphy@sgtuniversity.org  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SGT University 
Address  SGT University, Chandu Budhera, gurugram, India,122505 
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 
Annanya Verma  SGT Hospital  SGT University, School of Physiotherapy, Chandu, Budhera, haryana, India, 122505
Gurgaon
HARYANA 
07079011401

annanyav35@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee, Faculty of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N958||Other specified menopausal and perimenopausal disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  6 WEEK MULTIMODAL INTERVENTION PROGRAM   six weeks protocol to patients with post-menopausal women with pelvic floor dysfunction. For the groups, five minutes of warm-up, thirty minutes of main exercise, and five minutes of cool-down will be given .It includes pelvic floor strengthening, abdominal strengthening exercises and kinesio taping 
Comparator Agent  kegals exercise  , it will be control group that will receive Kegels exercise as conventional therapy. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1.45-65 years old women
2.Clinical diagnosis or self-reported symptom of pelvic floor dysfunction.
 
 
ExclusionCriteria 
Details  1.Urinary tract infection
2.Any neurological disorder
3.Recent Pelvic or abdominal surgery
4.Constipation
5.Pelvic malignancy
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Perineometer
2.Pressure biofeedback
3.Pelvic pain impact questionnaire
4.International Consultation on Incontinence Questionnaire – Urinary Incontinence (ICIQ-UI SF) 
baseline and after six week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Bioelectrical impedance analysis
2.SF-12 questionnaire 
baseline & sixth week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   31/12/2025 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

NEED OF THE STUDY: There is a growing need to address pelvic health concerns in postmenopausal women, as hormonal changes during menopause significantly impact pelvic floor function, leading to issues such as urinary incontinence, pelvic organ prolapse, and sexual dysfunction. Despite the high prevalence and negative impact of these conditions on women’s quality of life, they are often overlooked or inadequately managed, largely due to social stigma, lack of awareness, and limited access to effective, non-surgical treatment options. While individual interventions such as pelvic floor exercises or lifestyle modifications have shown benefits, there is limited evidence on the effectiveness of multimodal intervention programs that combine several therapeutic strategies for a more holistic approach. A well-designed randomized controlled trial is necessary to evaluate the comprehensive benefits of such programs, providing strong clinical evidence to guide practice. By addressing this gap, the study can contribute to the development of more effective, accessible, and preventive healthcare strategies for postmenopausal women, ultimately improving their long-term physical and psychological well-being.

SIGNIFICANCE OF THE STUDY: The significance of this study lies in its potential to improve the management of pelvic health in postmenopausal women, a population often affected by pelvic floor dysfunctions such as urinary incontinence, pelvic organ prolapses, and sexual dysfunction. These conditions, though common, are frequently underreported and inadequately addressed, leading to a diminished quality of life. By evaluating the impact of a multimodal intervention program—which may include pelvic floor muscle training, physical therapy, lifestyle modification, and health education—this randomized controlled trial offers a non-invasive, cost-effective alternative to pharmacological or surgical treatments. The study addresses a critical gap in the literature by providing high-quality evidence on the effectiveness of a comprehensive approach specifically tailored for postmenopausal women. Furthermore, it has the potential to influence clinical guidelines, support the development of preventive care strategies, and promote awareness and empowerment among women regarding pelvic health. Ultimately, the findings may lead to improved physical, emotional, and social well-being for a large and often underserved segment of the female population.

 
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