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

NCT ID: NCT05948397

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-08-01

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Incontinence, Urge Incontinence Stress Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

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

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

Intervention Type DIAGNOSTIC_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.

Bladder diary

Intervention Type DIAGNOSTIC_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

Pad test

Intervention Type DIAGNOSTIC_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

Interventions

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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.

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Female patients above 18 years old with mixed urinary incontinence

Exclusion Criteria

* Non-Turkish speakers
* Poor conscious level
* Immobile patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Koç University

OTHER

Sponsor Role lead

Responsible Party

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Ersin Köseoglu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tufan Tarcan, Prof

Role: CONTACT

905434948365

Ersin Köseoğlu

Role: CONTACT

905306930442

Other Identifiers

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KocUrol2

Identifier Type: -

Identifier Source: org_study_id

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