| CTRI Number |
CTRI/2024/11/076341 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Health Education] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In female stress urinary incontinence the education, exercise and electrical stimulation is crucial to improve the urine loss, strength of pelvic floor muscle and quality of life in patients. |
|
Scientific Title of Study
|
Effects of education, electrical stimulation and pelvic floor muscle exercise on strength,Quality of Life, Severity in female stress urinary incontinence |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M L Ramya Krishna |
| Designation |
Assistant Professor |
| Affiliation |
Apollo Institute of Medical Science and Research |
| Address |
Apollo college of Physiotherapy, 1st floor near library lobby, Apollo Institute of Medical Science and resaerch, Murakambattu, Chittoor, Chittoor District, Andhra Pradesh - 517127, India.
Chittoor
ANDHRA PRADESH
517127
India |
| Phone |
9010808414 |
| Fax |
|
| Email |
m.l.ramyakrishna1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Satya Narayana |
| Designation |
Professor |
| Affiliation |
The Apollo University |
| Address |
Room no: 327, 3rd floor,
Department of Biomedical science, School of Health Sciences, The Apollo University, Murakambattu, Chittoor, Chittoor District,Andhra Pradesh - 517127, India.
Chittoor
ANDHRA PRADESH
517127
India |
| Phone |
9959540302 |
| Fax |
|
| Email |
profsr@apollouniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Satya Narayana |
| Designation |
Professor |
| Affiliation |
The Apollo University |
| Address |
Room no: 327, 3rd floor,
Department of Biomedical science, School of Health Sciences, The Apollo University, Murakambattu, Chittoor, Chittoor District,Andhra Pradesh - 517127, India.
Chittoor
ANDHRA PRADESH
517127
India |
| Phone |
9959540302 |
| Fax |
|
| Email |
profsr@apollouniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Apollo college of Physiotherapy, 1st floor near library lobby, Apollo
Institute of Medical Science and resaerch, Murakambattu, Chittoor,
Chittoor District, Andhra Pradesh - 517127, India. |
| Apollo District head Quarter hospital, AIMSR, Chittoor, Andhra Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
M L Ramya Krishna |
| Address |
Apollo college of Physiotherapy, 1st floor near library lobby, Apollo Institute of Medical Science and resaerch, Murakambattu, Chittoor, Chittoor District, Andhra Pradesh - 517127, India. |
| 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 Kiran V |
District Headquarters Hospital, Apollo Institute of Medical Sciences and Research |
Room no 31, Physio OPD, Apollo District Headquarters Hospital, Apollo Institute of Medical Sciences and Research
Chittoor
ANDHRA PRADESH |
9573370002
kiran_v@aimsrchittoor.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PG/16/IEC/AIMSR/2024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Education and Pelvic floor muscle exercise |
3 session per week for 8 consecutive weeks |
| Intervention |
Education, Russian current electrical stimulation and Pelvic floor exercise |
3 sessions per week for 8 consecutive weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
SUI greater than 1 times per week, SUI symptoms, women were asked whether they leaked urine when they coughed, sneezed, laughed, or exercised or with physical exertion, such as lifting something heavy or moving furniture. |
|
| ExclusionCriteria |
| Details |
Pregnancy
Post menopausal women
Previous UI surgery, medications
Known malignancy in lower abdomen
Impaired bladder or sphincter function
Macroscopic haematuria
Inter menstrual bleedings
Severe psychiatric disorders &Neurological diseases with affection on sensibility in legs or lower limb
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perineometer
Kings health questionnaire
1 hour pad test
|
8th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BMI
Age
Cough stress test |
8th week |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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 2 |
|
Date of First Enrollment (India)
|
26/12/2024 |
| 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="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
|
Urinary
incontinence (UI) is a common condition that affects the quality of life (QoL)
of women at different stages of life. To date, about 50% of UI cases are due to
stress urinary incontinence (SUI).The overall
prevalence of UI
ranges from 8-45% in
women in different studies in
india15,16.the prevalence of SUI
in Indian females with age group
of 18-32 was (25.8%)and age group of 33-48was (33.7%)17.Socioeconomic report demonstrates that across all
EU countries, the estimated economic burden of UI was €69.1 billion in 202318. Adding Education, Electrical stimulation to
PFMT makes any difference in terms of severity, strength, quality of life
inconclusive and shows very low quality evidences and there is scarcity of the
studies using individual electrical stimulation and Russian currents, and in other
studies Russian current prompted to show positive results on muscle strength. Our
hypothesis is to find out the effects of Education, Electrical stimulations, Exercises
may improve the urinary leakage and pelvic floor muscle strength and QOL. |