Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Sleep Parameters and Quality of Life in Women with Urinary Incontinence
Recruiting now
Conditions studied: Women, Urinary Incontinence (UI), Nocturia
In brief
Urinary incontinence (UI), a common issue, is the involuntary leakage of urine that negatively affects individuals socially, physically, and psychologically, leading to a decreased quality of life. Nocturia, which is often seen alongside UI, has similar adverse effects. Nocturia refers to the number of urinations during the main sleep period, and it should be accompanied by the intention to fall back asleep after waking up. Nocturia can arise from factors such as sleep disorders and circadian rhythm disturbances. The circadian rhythm regulates the body's biological functions, and this rhythm varies from person to person, creating chronotypes. There is a strong relationship between sleep and nocturia because nocturia leads to deep sleep loss, an increased risk of metabolic diseases, decreased sleep quality and sleep efficiency, and an increase in the number of awakenings after sleep onset. It is necessary to distinguish whether nocturia, which has a comprehensive impact, affects pelvic floor symptoms, chronotype, sleep quality, fatigue, sleepiness, and quality of life in women with UI. Therefore, the aim of this study is to examine the effect of nocturia on pelvic floor symptoms, chronotype, sleepiness, sleep quality, fatigue, and quality of life in women with UI.
Key facts
- Study ID
- NCT06866834
- Run by
- Gulhane School of Medicine
- People needed
- 102
- Starts
- 2025-01-01
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2025-03-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Health Sciences Gülhane Faculty of Physiotherapy and Rehabilitation — Ankara, Keçiören, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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