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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05948397
• Other study ID #: KocUrol2
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: July 2023
• Source: Koç University
• Contact: Tufan Tarcan, Prof
• Phone: 905434948365
• Email: bilgi[@]tufantarcan.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Female patients above 18 years old with mixed urinary incontinence

Exclusion Criteria:

• Non-Turkish speakers

• Poor conscious level

• Immobile patients

Related Conditions & MeSH terms

• Enuresis
• Incontinence Stress
• Incontinence, Urge
• Quality of Life
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Consultation on Incontinence Questionnaire Short Form	Questionnaire	1 month
Primary	Pad test	Diagnostic Test	1 month
Primary	Bladder diary	Diagnostic Test	1 month