NCT05948397

Brief Summary

The goal of this observational study is detecting the dominant component of mixed urinary incontinence via a combined version of ICIQ-SF and quality of life scale. The main question it aims to answer is: 1\. Which component (urgency or stress) urinary incontinence bothers the patient more?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Status
unknown

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

First Submitted

Initial submission to the registry

July 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 9, 2023

Last Update Submit

July 9, 2023

Conditions

Incontinence, UrgeIncontinence StressQuality of Life

Outcome Measures

Primary Outcomes (3)

  • International Consultation on Incontinence Questionnaire Short Form

    Questionnaire

    1 month

  • Pad test

    Diagnostic Test

    1 month

  • Bladder diary

    Diagnostic Test

    1 month

Study Arms (1)

Study Group

Female patients admitted to urology outpatient clinic with mixed urinary incontinence.

Diagnostic Test: Combined version of International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) and quality of life scaleDiagnostic Test: Bladder diaryDiagnostic Test: Pad test

Interventions

Combined version of International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) and quality of life scaleDIAGNOSTIC_TEST

A combined version of International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and quality of life scale would be given to all patients. The sum of the responses for the third, fourth and fifth questions and quality of life scale scores will be recorded.

Study Group
Bladder diaryDIAGNOSTIC_TEST

Bladder diary is an online application. Frequency, nocturia, functional bladder capacities will be reported. More than 8 urination during daytime will be recorded as overactive bladder. More than 1 interruption of sleep for urination at night is nocturia. Functional bladder capacity below 100 ml will be defined as decreased bladder capacity, while capacity over 400 ml will be reported as increased bladder capacity and compliance

Study Group
Pad testDIAGNOSTIC_TEST

One-hour pad test. * the test is started by putting one pre-weighted pad without patient voiding, -patient drinks 500 ml of sodium-free liquid in \<15 min- then sits or rests, * patient walks for 30 min, including climbing one flight of stairs (up and down), * patient performs the following activities: standing up from sitting (10 ), coughing vigorously (10 ), running on the spot for 1 min, bending to pick up an object from the floor (5 ), and washing hands in running water for 1 min (this activity program may be modified according to the patient's physical fitness), * the total amount of urine leaked is determined by weighing the pad. In the analysis of 1-hr pad test, an increase of 1-10 g is classified as representing mild incontinence, 11-50 g moderate and \>50 g severe incontinence. The values for 24-hr pad test are classified as follows: Mild (4-20 g/ 24 hr), moderate (21-74 g/24 hr), and severe (\>75 g/24 hr) incontinence

Study Group

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients above 18 years old.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females with mixed urinary incontinence

You may qualify if:

  • Female patients above 18 years old with mixed urinary incontinence

You may not qualify if:

  • Non-Turkish speakers
  • Poor conscious level
  • Immobile patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, UrgeUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tufan Tarcan, Prof

CONTACT

905434948365bilgi@tufantarcan.com

Ersin Köseoğlu

CONTACT

905306930442ersinkoseoglu@ku.edu.tr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 17, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2025

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share