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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 90 years
• Women only
• Healthy volunteers accepted
• Adult, Older adult

Study population: Females with mixed urinary incontinence

Trial locations and contacts

No sites are listed yet.

About this study

Conditions

Incontinence, Urge, Incontinence Stress, Quality of Life

Being tested

Combined version of International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) and quality of life scale, Bladder diary, Pad test

Medical subject headings

Urinary Incontinence, Urge, Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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.

• 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

• 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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. International Consultation on Incontinence Questionnaire Short Form

   Questionnaire

   Measured: 1 month

2. Pad test

   Diagnostic Test

   Measured: 1 month

3. Bladder diary

   Diagnostic Test

   Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Jul 2023
2. Study start1 Aug 2023 (estimated)
3. Primary completion1 Aug 2024 (estimated)
4. Study completion1 Aug 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Incontinence, UrgeStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.