Clinical trial NCT04470700: Predictors of Delay in Treatment of Urinary Incontinence
Official title: Predictors of Delay in Treatment of Urinary Incontinence Among Pakistani Women - a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 298
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Predictors of delay in treatment of urinary incontinence
timeFrame: 6months from1st june2019 to 30 november 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lady Willingdon Hospital
state: Punjab
Study officials:
affiliation: King Edward Medical University,Lahore, Pakistan
name: Shazia Saaqib, FCPS,MCPS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.