| CTRI Number |
CTRI/2025/09/094763 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Presence of urinary, bowel and sexual dysfunctions among women with infertility visiting a tertiary care hospital |
|
Scientific Title of Study
|
Prevalence of pelvic floor dysfunctions in women with infertility visiting a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Associate Professor, Department of Physiotherapy,Manipal College of Health Professions,Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
09945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Associate Professor, Department of Physiotherapy,Manipal College of Health Professions,Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
09945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Associate Professor, Department of Physiotherapy,Manipal College of Health Professions,Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
09945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Madhav Nagar
Manipal-576104
Karnataka India |
| Type of Sponsor |
Private medical college |
|
|
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 Preetha R |
Manipal Academy of Higher Education |
Ground floor,Department of reproductive medicine and surgery OPD,Room number 01,Kasturba Hospital,Manipal-576104,Udupi,Karnataka
Udupi
KARNATAKA |
09945670669
preetha.r@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, (2) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged between 18 to 45 years
Women with primary or secondary infertility
|
|
| ExclusionCriteria |
| Details |
Women who have currently/recently undergone any artificial reproductive techniques
Diagnosed Psychiatric conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Australian pelvic floor questionnaire |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="167"
Sample Size from India="167"
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)
|
25/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Women will be screened and informed consent will be obtained from those who meet the selection criteria. Anthropometric measurements will be recorded and the questionnaire will be administered. Primary investigator will collect the filled questionnaire and data will be analysed |