| CTRI Number |
CTRI/2025/07/091186 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of exercises and nerve stimulation on urine leakage in postmenopausal women |
|
Scientific Title of Study
|
Synergistic evaluation of Abdominal Hypopressive Exercise and Transcutaneous Tibial Nerve Stimulation in managing mixed urinary incontinence among postmenopausal women QUASI experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadarshini |
| Designation |
Postgraduate student |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
4th floor, department of physiotherapy,
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES
#395, sarojinini naidu road, sidhapudur, coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8270709546 |
| Fax |
|
| Email |
priyajames1315@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surya gopalakrishnan |
| Designation |
Assistant professor |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
3rd floor, department of physiotherapy SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES
#395, sarojinini naidu road, sidhapudur, coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9496808936 |
| Fax |
|
| Email |
suryagopalakrishnans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyadarshini |
| Designation |
Postgraduate student |
| Affiliation |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
3rd floor, department of physiotherapy SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES
#395, sarojinini naidu road, sidhapudur, coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8270709546 |
| Fax |
|
| Email |
priyajames1315@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Priyadarshini |
| Address |
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES
395 sarojini naidu road, sidhapudur , coimbatore -641044 |
| Type of Sponsor |
Other [Myself] |
|
|
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 |
| Priyadarshini |
Sri ramakrishna hospital |
1st floor, department of obstetrics and gynaecology
SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES#395, sarojinini naidu road, sidhapudur, coimbatore
Coimbatore
TAMIL NADU |
08270709546
priyajames1315@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri ramakrishna hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abdominal Hypopressive Exercise and Transcutaneous Tibial Nerve Stimulations |
Single group - receiving Abdominal Hypopressive Exercise and Transcutaneous Tibial Nerve Stimulation for 6 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Menopause for greater than 1 year
Body mass index is average
ICIQ SF score ranges from 2 to 21 points
one hour Pad test severity is mild to moderate
Able to understand the procedure advantages and possible side effects
Able to write and give informed consent form
Participants who answered yes for both the question were included
First question is during the past month have you involuntarily got wet while performing some kind of physical exertion
Second question is during the past month have you experienced such as a strong urge to urinate that it was impossible to get to the toilet in time.
|
|
| ExclusionCriteria |
| Details |
Presence of Pelvic organ prolapse
Frequent vaginal or urinary tract infections
Presence of any neurological diseases
medication users for urinary incontinence
Diabetes mellitus
Hypertension
Abdominal hernia
Cardiorespiratory diseases
Active cancer
Pelvic and gynaecological surgery within 3months
Previous exposure to Abdominal Hypopressive Techniques and Transcutaneous Tibial Nerve Stimulation
Presence of any metal implants in lower limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • International Consultation of Incontinence Questionnaire for Urinary Incontinence – Short Form (ICIQ UI – SF) |
At baseline and after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| One hour pad test |
At baseline and after 6weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
28/07/2025 |
| 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="0"
Months="6"
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
|
20 Patients of mixed urinary incontinence in postmenopausal women are taken from Sri Ramakrishna Hospital, Department of obstetrics and gynaecology. These patients are assigned according to the inclusion and exclusion criteria. Patients are allocated in treatment group using purposive sampling method. The pre-test measures are obtained by ICIQ-SF questionnaire and 1-hr pad test for evaluating the severity and symptoms of mixed urinary incontinence. A well explained consent form is given and approval of patients are received. The treatment group will receive abdominal hypopressive exercises and transcutaneous tibial nerve stimulation for about 3days/weeks for about 4 weeks.The procedure of the intervention protocol is well explained to the patient with precautions Again after 4 weeks re-evaluation is conducted using ICIQ-SF questionnaire and 1-hr pad test for reduced symptoms and severity of mixed urinary incontinence. Finally, the abdominal hypopressive exercises and transcutaneous tibial nerve stimulation is effective in reducing the symptoms and severity of mixed urinary incontinence and improving the day to day of life is determined. |