Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Sleep Parameters and Quality of Life in Women with Urinary Incontinence

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorGulhane School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosis of a sleep disorder

Diagnosis of any neurological disease

Chronic kidney disease

Diagnosis of diabetes

Trial population

Gülhane Training and Research Hospital, Department of Obstetrics and Gynecology

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

102 Participants
are grouped into 2 trial groups
Group A: Group with nocturia
Group B: Group without nocturia

Trial outcomes

Primary outcomes

1

Assessment of Symptoms

To determine the discomfort caused by pelvic floor dysfunction symptoms, the "Global Pelvic Floor Discomfort Questionnaire" will be used. The Global Pelvic Floor Discomfort Questionnaire consists of 9 questions. The score obtained from the scale ranges from 0 to 45, and to convert this score to a percentage, the total score is averaged and then multiplied by 20. As the score on the scale increases, the severity of the discomfort also increases.

Time frame
from January 2025 to April 2025
2

Assessment of Symptoms

To determine the discomfort caused by pelvic floor dysfunction symptoms, the "Urogenital Distress Inventory-6" will be used. The Urogenital Distress Inventory is a Likert-type scale consisting of 6 questions. The score obtained from the scale ranges from 0 to 18, and the score is converted into a percentage. As the score on the scale increases, the severity of the discomfort also increases.

Time frame
from January 2025 to April 2025
3

Assessment of Sleep Quality

Pittsburgh Sleep Quality Index will be used.Pittsburgh Sleep Quality Index scale has seven sub-scales that portray various domains of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Responses for each subscale are scored as 0-3. Having a global score of 5 or higher indicates bad sleep quality. sleepiness.

Time frame
from January 2025 to April 2025
4

Assessment of Chronotype

Chronotype assessment will be evaluated using the "Morningness-Eveningness Questionnaire." The questionnaire consists of 19 questions. It has a five-point scale, with each range corresponding to a different chronotype. Individuals who score between 70-86 are classified as "definitely morning type," those who score between 59-69 are classified as "closer to morning type," those who score between 42-58 are classified as "intermediate type," those who score between 31-41 are classified as "closer to evening type," and individuals who score between 16-30 are classified as "definitely evening type."

Time frame
from January 2025 to April 2025

Secondary outcomes

1

Assessment of Sleepiness

Epworth Sleepiness Scale(ESS) will be used. Its score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime

Time frame
from January 2025 to April 2025
2

Assessment of Fatigue

Fatigue will be assessed using the Fatigue Severity Scale (FSS). The FSS consists of 9 items designed to evaluate the severity of fatigue and its impact on daily activities. Each item is scored on a 7-point Likert scale, where 1 represents "strongly disagree" and 7 represents "strongly agree." Higher scores indicate greater fatigue severity. The total score is calculated by averaging the responses across all items. Scores of 4 or above indicate the presence of fatigue.

Time frame
from January 2025 to April 2025

Other outcomes

Sponsors and contacts

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