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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04470700
Other study ID # 711/RC/KEMU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date November 30, 2020

Study information

Verified date July 2021
Source King Edward Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 298
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Lady Willingdon Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Shazia Saaqib

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View Citation

Lasserre A, Pelat C, Guéroult 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: 1 — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6months from1st june2019 to 30 november 2019
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