| CTRI Number |
CTRI/2025/06/089095 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| 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
|
Effect of Pelvic Floor Rehabilitation and Cognitive Behavioural Therapy on Vulvovaginal Atrophy and Mental Health in Postmenopausal WomenVulvovaginal Atrophy Symptoms and Associated Mental Health Outcomes in Post Menopausal Women |
|
Scientific Title of Study
|
Integration of Pelvic Floor Rehabilitation and Cognitive Behavioural Therapy on Vulvovaginal Atrophy Symptoms and Associated Mental Health Outcomes in Post Menopausal Women |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yukti Gogia |
| Designation |
PhD Scholar |
| Affiliation |
SGT University |
| Address |
SGT university
D block
lower ground floor
Gurgaon
HARYANA
122505
India |
| Phone |
9873016978 |
| Fax |
|
| Email |
yuktigogia92@gmail.cm |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pryanka Rishi |
| Designation |
Associate professor |
| Affiliation |
SGT University |
| Address |
SGT University
D Block
SGT University
Gurgaon
HARYANA
122505
India |
| Phone |
8588878467 |
| Fax |
|
| Email |
priyanka.physio@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yukti Gogia |
| Designation |
PhD Scholar |
| Affiliation |
SGT University |
| Address |
SGT University
D block
lower ground floor
Gurgaon
HARYANA
122505
India |
| Phone |
9873016978 |
| Fax |
|
| Email |
yuktigogia92@gmail.cm |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Yukti Gogia |
| Address |
Recovery stairway physiotherapy clinic
124-B new colony Gurgaon |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Yukti Gogia PT |
SGT University |
D block
lower ground floor
Room no. - LG-13
Gurgaon
HARYANA |
9873016978
yukti.recoverystairway007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee- Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
daily physical activity |
House hold activities
walking
stair climbing |
| Intervention |
Pelvic floor rehabilitation |
it will include following exercises
kegels
squats
bridging
bridging with pelvic floor contraction |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Post menopausal women
Absence of active infections
No recent surgeries
No recent hormone treatments
Age between 55 to 70 years
Diagnosed with vulvovaginal atrophy
|
|
| ExclusionCriteria |
| Details |
History of cancer
Untreated vaginal infections
Women who are on hormone replacement therapy
STD’s
Neurological or psychiatric conditions
Severe prolapse requiring surgical intervention
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Periniometer
Ultrasound imaging
Vaginal health Index
VSQ questionnaire
PFIQ questionnaire
|
Periniometer
Ultrasound imaging |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Urinary Incontinence - ICIQ- UI
Menqol
Ces-D |
Urinary Incontinence - ICIQ- UI
Menqol
Ces-D |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="1"
Months="0"
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
|
I am open for recruitment. Participants will be screened based on inclusion and exclusion criteria, specifically targeting post menopausal women with vulvovaginal atrophy Eligible participants will be enrolled after obtaining informed consent. Recruitment will be conducted in my physiotherapy OPD, Swastik clinic and Sai hospital. It is anticipated that recruitment will be completed within next 3 to 6 months. efforts are in place to ensure continuous enrolment until the target sample size is achieved. |