| CTRI Number |
CTRI/2025/01/079346 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study aims to understand how much men know about urinary leakage (involuntary urine loss), what causes it, and how it affects their daily life. It focuses on men visiting a hospital in Udupi district, Karnataka. |
|
Scientific Title of Study
|
A study to assess the awareness on urinary incontinence, factors contributing and its impact on quality of life among men attending medical outpatient department in a tertiary care hospital Udupi district, Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya |
| Designation |
Student |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing MAHE Manipal
Manipal Academy of Higher education Madhav Nagar Manipal
Udupi
KARNATAKA
576014
India |
| Phone |
8317444312 |
| Fax |
|
| Email |
aishwaryakunder600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Janet Alva |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Medical Surgical Nursing
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845646725 |
| Fax |
|
| Email |
janet.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Janet Alva |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Medical Surgical Nursing
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845646725 |
| Fax |
|
| Email |
janet.a@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of general Medicine, Kasturba hospital Manipal 576104
Udupi District Karnataka |
|
|
Primary Sponsor
|
| Name |
Department of general Medicine, Kasturba hospital Manipal |
| Address |
Medicine OPD, Kasturba Hospital, Manipal |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Aishwarya |
Kasturba Hospital Manipal |
Department of General Medicine, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
8317444312
aishwaryakunder600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 (Student Research) |
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
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
All the men aged above 40 years attending medicine outpatient department in Kasturba Hospital, Manipal, and those who are willing and interested in participating in the study. |
|
| ExclusionCriteria |
| Details |
Men who are not able to give any information and men below 40 years.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of the study the outcome measures are, awareness, factors
contributing and quality of life of people with urinary incontinence. |
within 8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the secondary outcome is, this study can be useful for the community to understand the urinary incontinence & they can even gain the knowledge by using the information booklet |
after 8 months |
|
|
Target Sample Size
|
Total Sample Size="386"
Sample Size from India="386"
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)
|
03/02/2025 |
| 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="8"
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
|
This study aims to assess the knowledge on urinary incontinence, factors contributing and their quality of life among men aged above 40 years which helps to understand the problems faced in their daily activities. Identifying the factors contributing will aid in preventing the urinary incontinence.
The objectives of the study are: · To assess the quality of life among men with urinary incontinence by using I-QOL questionnaire. · To find the correlation between knowledge, factors contributing urinary incontinence and quality of life among men. · To develop and validate an information booklet on self-care management of urinary incontinence.
|