| CTRI Number |
CTRI/2025/03/082376 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
effectiveness of bladder training programme on stress urinary incontinence among women |
|
Scientific Title of Study
|
A study to assess effectiveness of multifaceted bladder training programme on continence and quality of life among parous women with stress urinary incontinenceat selected rural areas, Mangaluru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amisha S Amin |
| Designation |
Assistanr Professor- stage 1 |
| Affiliation |
Yenepoya Nursing College |
| Address |
OBG nursing Department (5th Floor)
Yenepoya Nursing College
Yenepoya (DEMMED TO BE University), Naringana, Kinya Mangaluru
Yenepoya (Deemed to be university)
Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9380189436 |
| Fax |
- |
| Email |
amishaamin42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Leena KC |
| Designation |
Principal/Dean |
| Affiliation |
Yenepoya Nursing College |
| Address |
Principal/Professor of community health nursing department
Yenepoya Nursing College
Yenepoya deemed to be University, Naringana, Kinya, Mangaluru
Yenepoya University, Derlakatte Post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
94480 59698 |
| Fax |
- |
| Email |
leenakchacko@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Timi Thomas |
| Designation |
Scientific review Board incharge |
| Affiliation |
Yenepoya Nursing College |
| Address |
Yenepoya Nursing College
Yenepoya University, Derlakatte, Mangaluru
Yenepoya University, Derlakatte post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
81237 65753 |
| Fax |
- |
| Email |
timithomas@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Study is conducted under yenepoya deemed to be university as a part of my phD study..
Study setting: rural community of Mangaluru( Kotekar, Amblamogaru) |
|
|
Primary Sponsor
|
| Name |
Amisha S Amin |
| Address |
Assistant proffesor
OBG nursing department
Yenepoya nutsing college
Mangaluru |
| 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 Amisha |
Yenepoya deemed to be university |
OBG nursing department
Yenepoya nursing college
Yenepoya deemed to be university
Derlakatte post, Mangalore
Dakshina Kannada
KARNATAKA |
9380189436
-
amishaamin42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics committee 1 |
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 |
| Intervention |
bladder training programme |
-pelvic floor exercise twice a day for 12 weeks
-deep breathing exrcise as urge suppression technique done before every void
-bladder dairy
-life style modification education |
| Comparator Agent |
no intervention |
no intervention |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parous women who are
aged between 25-40 years with history of at least one vaginal delivery
willing to participate in the study
know to read and write Kannada or English
available at the time of data collection |
|
| ExclusionCriteria |
| Details |
Parous women who are
on treatment for incontinence like pharmacological treatment, pelvic floor physiotherapy and surgery for incontinence management
chronic co-morbid illness like high-grade uterine prolapse and pelvic cancer
History of vaginal delivery in last 12 months
Previous participation in PFMT program
Pregnant at the time of data collection |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life, strength of perineal muscle and decrease in stress urinary incontinence |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improving quality of life of women |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
30/03/2025 |
| 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="3"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
women face various health problems during pregnancy and after delivery. One such problem faced during childbirth, and which continues after delivery for lifetime is stress urinary incontinence. This occurs because of weakened pelvic floor muscles during childbirth. stress urinary incontinence affects quality of life of women. It may affect her in doing day to day activities, social activities, travelling, sexual life with husband and many other. Though many women face this problem, they fail to express it or ignore it as young adults and face serious problems like vaginal infection, genital rashes, urinary leakage, bad odor due to urine leakage etc. Multifaceted bladder training programme in this study includes Kegels exercise, urge suppression technique and lifestyle modification teaching. These techniques are known to increase perineal strength and gain control over urination. So, this study is aimed to assess effectiveness of multifaceted bladder training programme among parous women with stress urinary incontinence. |