Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT06866834
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria for the Group with Nocturia:
* Being 18 years of age or older
* Being female
* Have been diagnosed with urinary incontinence
* Wake up during the main sleep period to relieve the need to urinate, with the intention of returning to sleep or falling asleep again after each urination
Inclusion Criteria for the Group without Nocturia:
* Being 18 years of age or older
* Being female
* Have been diagnosed with urinary incontinence
Exclusion Criteria:
Exclusion Criteria for the Group with Nocturia:
* Diagnosis of a sleep disorder
* Diagnosis of any neurological disease
* Chronic kidney disease
* Diagnosis of diabetes
* Use of sleep medications
* Use of antidepressants
* Use of diuretic medications
* Use of any medication for urinary incontinence
* Hormone replacement therapy
* Pregnancy or having given birth within the last six months
* Having had a urinary tract infection in the last three months
* Presence of prolapse greater than stage 2
* History of orthopedic trauma to the pelvic region
* Pelvic surgery within the last six months
* History of cancer
Exclusion Criteria for the Group without Nocturia:
* Waking up during the main sleep period to relieve the need to urinate, with the intention of returning to sleep or falling asleep again after each urination
* Diagnosis of a sleep disorder
* Diagnosis of any neurological disease
* Chronic kidney disease
* Diagnosis of diabetes
* Use of sleep medications
* Use of antidepressants
* Use of diuretic medications
* Use of any medication for urinary incontinence
* Hormone replacement therapy
* Pregnancy or having given birth within the last six months
* Having had a urinary tract infection in the last three months
* Presence of prolapse greater than stage 2
* History of orthopedic trauma to the pelvic region
* Pelvic surgery within the last six months
* History of cancer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06866834
Study Brief:
Protocol Section:
NCT06866834