Urinary IncontinenceNCT06189469
Reliability and Validity of Urdu Version of the King's Health Questionnaire
An observational study of Urinary Incontinence, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 83 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 28 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 83 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females presenting with Urinary Incontinence
Who may be able to join
- Having symptoms of Urinary Incontinence
- Age 21 or more than years
- Sufficient literacy to complete questionnaire
Who cannot join
- Being unable to complete questionnaires due to language and cognitive limitations
- Pelvic organ prolapse
- Concomitant neurological disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Is Urdu Version of the King's Health Questionnaire a Reliable and Valid Tool
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.
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, King's Health Questionnaire, Reliability, Validity
- Medical subject headings
- Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start30 May 2021
- Primary completion25 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189469
- Sponsor's protocol ID
- REC-FSD-00257
- Status last verified
- Dec 2023
- First submitted
- 24 Jul 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Urdu Version of the King's Health Questionnaire a Reliable and Valid Tool
- ClinicalTrials.gov ID
- NCT06189469
- Acronym / sponsor ID
- REC-FSD-00257
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, King's Health Questionnaire, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 83 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females presenting with Urinary Incontinence
Key inclusion criteria (3 listed)
- Having symptoms of Urinary Incontinence
- Age 21 or more than years
- Sufficient literacy to complete questionnaire
Key exclusion criteria (3 listed)
- Being unable to complete questionnaires due to language and cognitive limitations
- Pelvic organ prolapse
- Concomitant neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
King's Health Questionnaire
Time frame: 7th day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
King's Health Questionnaire (time frame: 7th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.