To Use the Combined Version of ICIQ-SF and Quality of Life Scale in Mixed Urinary Incontinence

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Incontinence, Urge; Incontinence Stress
• Intervention / Treatment: Diagnostic test: Combined version of International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) and quality of life scale; Diagnostic test: Bladder diary; Diagnostic test: Pad test

Detailed Description

Female patients with mixed urinary incontinence will be given a combined version of ICIQ-SF and quality of life scale on the first visit. Additionally, a bladder diary and 1-hour pad test will be performed on the same visit. After deciding the appropriate treatment, on the 1-month visit (second visit) the same tests will be repeated and scores will be compared.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Tufan Tarcan, Prof; Phone Number: 905434948365; Email: bilgi@tufantarcan.com
• Study Contact Backup: Name: Ersin Köseoğlu; Phone Number: 905306930442; Email: ersinkoseoglu@ku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Females with mixed urinary incontinence

Description

Inclusion Criteria:

• Female patients above 18 years old with mixed urinary incontinence

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 scale; 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.; Diagnostic test: Bladder diary; 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; Diagnostic test: Pad 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire Short Form	Questionnaire	1 month
Pad test	Diagnostic Test	1 month
Bladder diary	Diagnostic Test	1 month

Collaborators and Investigators

• Sponsor: Koç University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: July 9, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Other Study ID Numbers: KocUrol2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No