- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04470700
Predictors of Delay in Treatment of Urinary Incontinence (Predictors)
Predictors of Delay in Treatment of Urinary Incontinence Among Pakistani Women - a Cross-sectional Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 042
- Lady Willingdon Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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subjects with greater than 3years delay
Subjects with delay in treatment of Urinary incontinence greater than three years
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subjects with less than three years delay
Subjects with delay in treatment of Urinary incontinence lesser than three years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictors of delay in treatment of urinary incontinence
Time Frame: 6months from1st june2019 to 30 november 2019
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the risk factors of incontinence treatment delay wich are shared by the women with delayed help seeking behaviour
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6months from1st june2019 to 30 november 2019
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Shazia Saaqib, FCPS,MCPS, King Edward Medical University,Lahore, Pakistan
Publications and helpful links
General 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.
- Norton 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.
- Corcos 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.
- Lasserre 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 711/RC/KEMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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