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

Sponsor

Koç University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05948397

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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:

Which component (urgency or stress) urinary incontinence bothers the patient more?

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urge Incontinence Stress Quality of Life	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

International Consultation on Incontinence Questionnaire Short Form [1 month]
Questionnaire
Pad test [1 month]
Diagnostic Test
Bladder diary [1 month]
Diagnostic Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Female patients above 18 years old with mixed urinary incontinence

Exclusion Criteria:

Non-Turkish speakers
Poor conscious level
Immobile patients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Koç University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ersin Köseoglu, MD, Koç University

ClinicalTrials.gov Identifier:

NCT05948397

Other Study ID Numbers:

KocUrol2

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Urge

Urinary Incontinence, Stress

Study Results

No Results Posted as of Jul 17, 2023