Reliability and Validity of Urdu Version of the King's He... | NCT06189469

Studies
Reliability and Validity of Urdu Version of the King's Health Questionnaire

NCT06189469

Sponsor

Riphah International University

Status

Completed

Last Update Posted

Jan 3, 2024Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Urinary Incontinence

Interventions

Not provided

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2021Actual

Primary Completion Date

Jul 25, 2022Actual

Completion Date

Jul 28, 2022Actual

First Submitted Date

Jul 24, 2022

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Jan 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2023

Last Update Posted Date

Jan 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is aimed to translate King's Health Questionnaire into Urdu language and to test its reliability and validity among Pakistani women with urinary incontinence.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
King's Health Questionnaire	Change from Baseline (1st day)The King's Health Questionnaire is a disease-specific health-related quality-of-life instrument to measure health-related quality-of-life of patients with urinary incontinence	7th day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having symptoms of Urinary Incontinence
Age 21 or more than years
Sufficient literacy to complete questionnaire

Exclusion Criteria:

Being unable to complete questionnaires due to language and cognitive limitations
Pelvic organ prolapse
Concomitant neurological disorders

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

83 Years

Standard Ages

AdultOlder Adult

Study Population

Females presenting with Urinary Incontinence

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad Kashif	Riphah International University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Riphah International University		Faisalabad	Punjab Province	38000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided