Urinary IncontinencePredictorsNCT04470700
Predictors of Delay in Treatment of Urinary Incontinence
An observational study of Urinary Incontinence, run by Shazia Saaqib at 1 site in Pakistan.
Trial summary
246 women were selected as participants to fill and submit the Study Proforma among 264 incontinent women. The Performa included demographic features of the subjects, their chronic ailments, psychosocial effects, reasons for the delay, and Incontinence Questionnaire UI-short form of incontinence characteristics. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- How many people
- 298 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2019to 30 Nov 2020
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The women who had complained of urinary incontinence for at least one year and did not pursue any treatment for this problem previously.
Who may be able to join
- The women who had the complaint of urinary incontinence for at least one year and did not pursue any treatment for this problem previously.
- age greater than 18 years
- urinary leakage for once a week during the previous three months.
- Incontinent women with or without chronic medical problems
Who cannot join
- urinary tract infection
- patients with pregnancy or within three months postpartum
- severe mental illness (unable to answer the questionnaire correctly)
- terminal stage illness (liver disease, kidney disease, or malignancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Delay in Treatment of Urinary Incontinence Among Pakistani Women - a Cross-sectional Study
246 women were selected as participants to fill and submit the Study Proforma among 264 incontinent women. The Performa included demographic features of the subjects, their chronic ailments, psychosocial effects, reasons for the delay, and Incontinence Questionnaire UI-short form of incontinence characteristics. We selected a sample of 198 completed questionnaires to be included in the study. IBM spss statistics 20(SPSS Inc, Chicago, IL, USA) were used to find predictors of delay in treating urinary incontinence.
Read the detailed description
Study design and participants:
A cross-sectional survey of 198 women with incontinence was conducted at lady Willingdon hospital from June 1, 2019, to November 30, 2020. The medical officers of gynecology outdoor scrutinized all the women who had complained of urinary incontinence for at least one year and did not previously pursue any treatment for this problem.
246 participants who fulfilled the study criteria signed written informed consent and got their Proforma filled either by themselves or by assisting the medical officer.
In previous studies, delay to the treatment of >3 years was considered significant; thus, all eligible women were divided into two groups based on the delay of up to three years and more than 3 years according to the duration of incontinence as stated by the subject and studied for predictors of incontinence.
Ethical approval This study had ethical approval from King Edward Medical University, Pakistan. the study was conducted according to the Declaration of the Helsinki and obtained informed consent from participants before the study commenced. All information collected from the participants was kept confidential, and Proformas were kept in a file in the custody of the main investigator after entering data in the spss datasheet.
Statistical analysis. The study results were calculated with SPSS version 20 (SPSS Inc., Chicago, IL, USA). The means and standard deviation were used to calculate the age of subjects and the duration of delay in seeking treatment. The subjects with potential risk factors were represented as numbers and percentages. The subjects with a short delay(less than or equal to three years) and a long delay (greater than three years) were presented as numbers and percentages for reporting their incontinence. Univariate analysis was performed on all risk factors of delay and then multivariate analysis on significant risk factors to determine the most commonly shared factors for delay in seeking treatment. P-value ≤ 0.05 was considered statistically significant.
- Conditions
- Urinary Incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects with greater than 3years delay | Subjects with delay in treatment of Urinary incontinence greater than three years | |
| subjects with less than three years delay | Subjects with delay in treatment of Urinary incontinence lesser than three years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of delay in treatment of urinary incontinence
the risk factors of incontinence treatment delay wich are shared by the women with delayed help seeking behaviour
Measured: 6months from1st june2019 to 30 november 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Jun 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shazia Saaqib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shazia Saaqib, King Edward Medical University
- Investigators
- Shazia Saaqib, FCPS,MCPS, Study chair, King Edward Medical University,Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470700
- Sponsor's protocol ID
- 711/RC/KEMU
- Acronym
- Predictors
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared after publication on a reasonable request.
Publications
Sensoy N, Dogan N, Ozek B, Karaaslan L. Urinary incontinence in women: prevalence rates, risk factors and impact on quality of life. Pak J Med Sci. 2013 May;29(3):818-22. doi: 10.12669/pjms.293.3404.
PubMed 24353635Norton PA, MacDonald LD, Sedgwick PM, Stanton SL. Distress and delay associated with urinary incontinence, frequency, and urgency in women. BMJ. 1988 Nov 5;297(6657):1187-9. doi: 10.1136/bmj.297.6657.1187. No abstract available.
PubMed 3144344Corcos J, Gajewski J, Heritz D, Patrick A, Reid I, Schick E, Stothers L; Canadian Urological Association. Canadian Urological Association guidelines on urinary incontinence. Can J Urol. 2006 Jun;13(3):3127-38.
PubMed 16813704Lasserre A, Pelat C, Gueroult V, Hanslik T, Chartier-Kastler E, Blanchon T, Ciofu C, Montefiore ED, Alvarez FP, Bloch J. Urinary incontinence in French women: prevalence, risk factors, and impact on quality of life. Eur Urol. 2009 Jul;56(1):177-83. doi: 10.1016/j.eururo.2009.04.006. Epub 2009 Apr 10.
PubMed 19376639
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Delay in Treatment of Urinary Incontinence Among Pakistani Women - a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04470700
- Acronym / sponsor ID
- Predictors / 711/RC/KEMU
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Shazia SaaqibUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 14 Jul 2020 (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.
246 women were selected as participants to fill and submit the Study Proforma among 264 incontinent women. The Performa included demographic features of the subjects, their chronic ailments, psychosocial effects, reasons for the delay, and Incontinence Questionnaire UI-short form of incontinence characteristics. We selected a sample of 198 completed questionnaires to be included in the study. IBM spss statistics 20(SPSS Inc, Chicago, IL, USA) were used to find predictors of delay in treating urinary incontinence.
Detailed description
Study design and participants:
A cross-sectional survey of 198 women with incontinence was conducted at lady Willingdon hospital from June 1, 2019, to November 30, 2020. The medical officers of gynecology outdoor scrutinized all the women who had complained of urinary incontinence for at least one year and did not previously pursue any treatment for this problem.
246 participants who fulfilled the study criteria signed written informed consent and got their Proforma filled either by themselves or by assisting the medical officer.
In previous studies, delay to the treatment of >3 years was considered significant; thus, all eligible women were divided into two groups based on the delay of up to three years and more than 3 years according to the duration of incontinence as stated by the subject and studied for predictors of incontinence.
Ethical approval This study had ethical approval from King Edward Medical University, Pakistan. the study was conducted according to the Declaration of the Helsinki and obtained informed consent from participants before the study commenced. All information collected from the participants was kept confidential, and Proformas were kept in a file in the custody of the main investigator after entering data in the spss datasheet.
Statistical analysis. The study results were calculated with SPSS version 20 (SPSS Inc., Chicago, IL, USA). The means and standard deviation were used to calculate the age of subjects and the duration of delay in seeking treatment. The subjects with potential risk factors were represented as numbers and percentages. The subjects with a short delay(less than or equal to three years) and a long delay (greater than three years) were presented as numbers and percentages for reporting their incontinence. Univariate analysis was performed on all risk factors of delay and then multivariate analysis on significant risk factors to determine the most commonly shared factors for delay in seeking treatment. P-value ≤ 0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with greater than 3years delay | – | –Subjects with delay in treatment of Urinary incontinence greater than three years |
| subjects with less than three years delay | – | –Subjects with delay in treatment of Urinary incontinence lesser than three years |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The women who had complained of urinary incontinence for at least one year and did not pursue any treatment for this problem previously.
Key inclusion criteria (4 listed)
- The women who had the complaint of urinary incontinence for at least one year and did not pursue any treatment for this problem previously.
- age greater than 18 years
- urinary leakage for once a week during the previous three months.
- Incontinent women with or without chronic medical problems
Key exclusion criteria (4 listed)
- urinary tract infection
- patients with pregnancy or within three months postpartum
- severe mental illness (unable to answer the questionnaire correctly)
- terminal stage illness (liver disease, kidney disease, or malignancy)
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
Predictors of delay in treatment of urinary incontinence
Time frame: 6months from1st june2019 to 30 november 2019
the risk factors of incontinence treatment delay wich are shared by the women with delayed help seeking behaviour
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 20 Jul 2021.
- Results publication: PubMed 24353635Sensoy N, Dogan N, Ozek B, Karaaslan L. Urinary incontinence in women: prevalence rates, risk factors and impact on quality of life. Pak J Med Sci. 2013 May;29(3):818-22. doi: 10.12669/pjms.293.3404.
- Results publication: PubMed 3144344Norton PA, MacDonald LD, Sedgwick PM, Stanton SL. Distress and delay associated with urinary incontinence, frequency, and urgency in women. BMJ. 1988 Nov 5;297(6657):1187-9. doi: 10.1136/bmj.297.6657.1187. No abstract available.
- Results publication: PubMed 16813704Corcos J, Gajewski J, Heritz D, Patrick A, Reid I, Schick E, Stothers L; Canadian Urological Association. Canadian Urological Association guidelines on urinary incontinence. Can J Urol. 2006 Jun;13(3):3127-38.
- Results publication: PubMed 19376639Lasserre A, Pelat C, Gueroult V, Hanslik T, Chartier-Kastler E, Blanchon T, Ciofu C, Montefiore ED, Alvarez FP, Bloch J. Urinary incontinence in French women: prevalence, risk factors, and impact on quality of life. Eur Urol. 2009 Jul;56(1):177-83. doi: 10.1016/j.eururo.2009.04.006. Epub 2009 Apr 10.
- The Prevalence and Determinants of Health Care-Seeking Behavior for Urinary Incontinence in United Arab Emirates WomenLink provided by the sponsor.
- The Relationship Between Urinary Incontinence, Mobility Limitations, and Disability in Older WomenLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data will be shared after publication on a reasonable request.
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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.
Shazia Saaqib, FCPS,MCPS study chair
King Edward Medical University,Lahore, Pakistan
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 Shazia Saaqib 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 4 inclusion and 4 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 20 Jul 2021. 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?
Predictors of delay in treatment of urinary incontinence (time frame: 6months from1st june2019 to 30 november 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470700, which also lists 4 linked publications.
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 20 Jul 2021.