| 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
|
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
SGT University, Chandu Budhera, gurugram, India,122505 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |