NCT04470700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

July 9, 2020

Last Update Submit

July 14, 2021

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale subjects above18 years of age
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Willingdon Hospital

Lahore, Punjab Province, 042, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 24353635RESULT

  • 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.

    PMID: 3144344RESULT

  • 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.

    PMID: 16813704RESULT

  • 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.

    PMID: 19376639RESULT

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shazia Saaqib, FCPS,MCPS

    King Edward Medical University,Lahore, Pakistan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor Obstetrics and Gynecology

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

June 1, 2019

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

The data will be shared after publication on a reasonable request.

Locations

PA(1)