| CTRI Number |
CTRI/2025/05/086761 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on finding effectiveness of structured pelvic floor exercise on postmenopausal women above 45years with loss of urine control, depression and quality of life |
|
Scientific Title of Study
|
Effectiveness of structured pelvic floor exercise programme on severity of stress urinary incontinence, depression and quality of life among postmenopausal 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 |
MAHISREEBHARATHIUV |
| Designation |
Assistant Professor |
| Affiliation |
VELS INSTITUTE OF SCIENCE TECHNOLOGY AND ADVANCED STUDIES |
| Address |
Shri Ishari Velan Mission Hospital, Room No. 215, vels college road, thazhambur, chengalpattu dist - 600130
Shri Ishari Velan Mission Hospital, Room No. 215, vels college road, thazhambur, chengalpattu dist - 600130
Chennai
TAMIL NADU
600130
India |
| Phone |
9790208808 |
| Fax |
|
| Email |
mahisree454@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sandhiya.M |
| Designation |
Assistant Professor |
| Affiliation |
VELS INSTITUTE OF SCIENCE TECHNOLOGY AND ADVANCED STUDIES |
| Address |
Shri Ishari Velan Mission Hospital, Room No. 213, vels college road, thazhambur, chengalpattu dist - 600130
Chennai
TAMIL NADU
600130
India |
| Phone |
9940583928 |
| Fax |
|
| Email |
sandhiya.sp@vistas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
MAHISREEBHARATHIUV |
| Designation |
Assistant Professor |
| Affiliation |
VELS INSTITUTE OF SCIENCE TECHNOLOGY AND ADVANCED STUDIES |
| Address |
Shri Ishari Velan Mission Hospital, vels college road, thazhambur, chengalpattu dist - 600130
Shri Ishari Velan Mission Hospital, vels college road, thazhambur, chengalpattu dist - 600130
Chennai
TAMIL NADU
600130
India |
| Phone |
9790208808 |
| Fax |
|
| Email |
mahisree454@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MahisreeBharathi.U.V |
| Address |
School of Physiotherapy, Vels Institute of Science Technology and Advanced Studies, Thalambur, Chennai, Tamilnadu - 600130 |
| Type of Sponsor |
Other [This study is sponsored by the principal investigator] |
|
|
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 |
| DrMahisreeBharathiUV |
shri Ishari Velan Mission hospital |
Shri Ishari Velan Mission Hospital, Room No.215, vels college road, thazhambur, chengalpattu dist - 600130
Chennai
TAMIL NADU |
09790208808
mahisree454@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VISTAS Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
stress urinary incontinence |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
postural correctio with kegels |
subjects in this group will be performing postural correction along with pelvic floor strengthening for 12 weeks |
| Intervention |
structured pelvic floor exercise programme |
subjects in this group will be performing structured pelvic floor exercise which comprises of different pelvic floor training programme for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1) Postmenopausal women with stress Urinary Incontinence based on QUID.
2) Wiling to participate and
who understands Tamil/English.
|
|
| ExclusionCriteria |
| Details |
1) Patients undergone surgical treatment for Stress Urinary Incontinence.
2) Inability to contract pelvic floor muscle voluntarily.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Stress Urinary Incontinence
2) Depression
3) Quality of Life |
1) Stress Urinary Incontinence - measured on baseline , 6 weeks and 12 weeks
2) Depression - measured on baseline , 6 weeks and 12 weeks
3) Quality of Life - measured on baseline , 6 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PELVIC FLOOR STRENGTH |
12 WEEKS |
|
|
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)
|
25/05/2025 |
| 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="3"
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
|
Stress Urinary incontinence is an important social problem that affects more than 38 to 55% of postmenopausal women. While urinary incontinence has a profound impact on quality of life, only few affected women seek care. Despite its high prevalence, it remains underdiagnosed and undertreated. Upto half of women may not report incontinence to their healthcare provider and this may be due to embarassment or to the belief that incontinence is a natural part of aging. Hence there is a need to understand the importance of focusing the population who suffered from incontinence as it leads to many serious conditions if left untreated. This study is an randomised controlled trial which will have two groups and both will receive pelvic floor training. group A (experimental group) will receive structured pelvic floor exercise programme for 12 weeks and Group B will receive postural correction with kegels for 12 weeks. Stress Urinary Incontinence, Depression and Quality of life will be measured as a primary outcome on baseline, 6 weeks and 12 weeks. Pelvic floor strength will be measured as a secondary outcome on baseline, 6 weeks and 12 weeks. This study will be conducted as a trial for main study to find the obstacles and struggles in order to avoid or rectify the mistakes in the main study as the duration is bit longer for 12 weeks. |