| CTRI Number |
CTRI/2024/09/074490 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Urine Leakage on Sleep ,Anxiety and Daily life in Young Females |
|
Scientific Title of Study
|
Impact of Stress Urinary Incontinence on Anxiety, Sleep Quality and Overall quality of life among young collegiate Females - A cross sectional 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 |
Dr Mohammad Sidiq |
| Designation |
Associate Proffesor |
| Affiliation |
Galgotias University |
| Address |
Room No 316,Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No.2, Sector 17A, Opposite Buddha International Circuit, Greater Noida,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Disha Mittal |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No E004,Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No.2, Sector 17A, Opposite Buddha International Circuit, Greater Noida,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9289489509 |
| Fax |
|
| Email |
mittaldisha44@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B317,Department of Physiotherapy, School of Allied Health Science, Galgotias University, Plot No.2, Sector 17A, Opposite Buddha International Circuit, Greater Noida,
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India ,203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India ,203201 |
| Type of Sponsor |
Research institution |
|
|
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 Mohammad Sidiq |
Galgotias University |
Room No.E004, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
6006204628
sidufatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Galgotias University |
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 |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
1. Age Group: Females aged 18 to 25 years, currently enrolled in a college or university program.
2. Diagnosis of Stress Urinary Incontinence (SUI): Participants with self-reported or clinically diagnosed stress urinary incontinence, characterized by involuntary leakage of urine during activities that increase intra-abdominal pressure (e.g., coughing, sneezing, exercising).
No Previous Pelvic Surgery: Participants who have not undergone any pelvic surgeries or medical interventions affecting the urinary or reproductive system.
3. Physically Active: Participants who engage in moderate physical activity or regular daily activities, as physical activity can impact SUI symptoms.
4. Willingness to Participate: Individuals who provide informed consent and are willing to complete all questionnaires and assessments related to the study.
5. Good General Health: Participants with no known chronic medical conditions (e.g., diabetes, heart disease, neurological disorders) that could independently contribute to urinary incontinence.
6. Non-Pregnant: Participants who are not pregnant and have not been pregnant within the past six months.
7. No Current Psychiatric Treatment: Females without a diagnosis of severe psychiatric disorders requiring ongoing psychiatric care, ensuring mental health conditions do not confound the study outcomes. |
|
| ExclusionCriteria |
| Details |
1. Females more than 30 years
2. Existing Urological Condition
3. Previous Pelvic Surgery
4. Pregnancy or Postpartum Status
5. Neurological Condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
King Health Questionnaire,
Perceived Stress Scale ,
Pittsburg Sleep Index,
SF 36
|
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Quality of Life will be assessed by SF 36 Questionnaire |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="323"
Sample Size from India="323"
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)
|
11/10/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mittaldisha44@gmail.com].
- For how long will this data be available start date provided 05-03-2025 and end date provided 19-09-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
This cross-sectional study investigates the impact of stress urinary incontinence (SUI) on anxiety, sleep quality, and overall quality of life (QoL) among young collegiate females aged 18-25. SUI, the involuntary leakage of urine during activities that increase intra-abdominal pressure, is often underreported in younger women, yet it can cause significant physical, psychological, and social challenges. The study aims to assess the prevalence of SUI in this population and explore its associations with anxiety (measured by PSS), sleep quality (using the Pittsburgh Sleep Quality Index), and overall QoL (via the SF-36 Health Survey). Participants with other urinary or chronic conditions, recent pregnancies, or pelvic surgeries are excluded. The findings are expected to highlight the overlooked impact of SUI in young women, advocating for early identification and management of this condition to improve their mental well-being, sleep patterns, and overall quality of life. |