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临床试验/NCT06866834
NCT06866834已完成不适用

Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Chronotype, Sleepiness, Sleep Quality, Fatigue and Quality of Life in Women With Urinary Incontinence

Gulhane School of Medicine1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Assessment of Symptoms

研究概览

简要总结

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.

详细描述

Urinary incontinence (UI) is defined as the involuntary leakage of urine. UI, which is commonly observed both globally and in our country, negatively affects individuals socially, physically, and psychologically, decreasing their quality of life. Nocturia, which is frequently seen alongside UI, has similar adverse effects. Nocturia is defined as the number of urinations during the main sleep period, and for these urinations to be considered as nocturia, the intention to fall back asleep after waking must be present. Nocturia can result from various causes, such as sleep disorders and circadian rhythm disturbances. Sleep is one of the biological functions regulated by the 24-hour cycle of body temperature, hormonal balance, hunger and satiety, cognitive and physical performance. This rhythm varies from person to person and creates chronotypes. Based on these chronotypes, the time during the day when individuals function best and when circadian time is regulated differs. There is an undeniable relationship between sleep and nocturia. Nocturia causes loss of deep sleep, known as slow-wave sleep, increases the risk of metabolic diseases, decreases sleep quality and sleep efficiency, and increases the number of awakenings after sleep onset. This decrease in sleep quality can lead to increased sleepiness, fatigue, and reduced quality of life. It is necessary to differentiate whether nocturia, which has a comprehensive effect, influences pelvic floor symptoms, chronotype, sleep quality, fatigue, sleepiness, and quality of life in women with UI. Therefore, the aim of this study is to investigate the effect of nocturia on pelvic floor symptoms, chronotype, sleepiness, sleep quality, fatigue, and quality of life in women with UI.

2. Materials and Methods This study was designed as a cross-sectional comparative study evaluating incontinent women with and without nocturia.

Participants: Participants in the study will be selected from patients who visit the Gynecology and Obstetrics Outpatient Clinic at GATA Training and Research Hospital. The study will include patients over the age of 18 who experience incontinence. After the patients are informed about the study, written and verbal consent will be obtained from them. The sample size for the study was calculated using the G*Power 3.1 program with a power of 80% and a type 1 error level of 0.05. It was calculated that a total of 102 people, with at least 51 participants in each group (with and without nocturia), would be required. The exclusion criteria for the study include sleep disorders, neurological diseases, chronic kidney disease, the use of sleep medication, antidepressants, diuretics, or urinary incontinence drugs, hormone replacement therapy, pregnancy or childbirth within the last six months, urinary tract infections in the last three months, prolapse beyond stage 2, orthopedic trauma to the pelvic region or pelvic surgery within the last six months, and a history of cancer.

Evaluation: A semi-structured evaluation form will be used to record the demographic data of the participants. The participants' anthropometric features such as age (years), height (cm), weight (kg) will be recorded. Educational level, marital status, occupation, main complaint, and duration of complaints (months) will be queried. Their medical history, surgeries, family history, medications, smoking, chronic cough, and constipation status will be noted. Obstetric history and menstrual status will be collected. The type of incontinence will be evaluated using the 3 Incontinence Questions (3IQ) survey, urinary symptoms will be assessed with the Global Pelvic Floor Distress Inventory and Urogenital Distress Inventory-6, chronotypes will be evaluated using the Morningness-Eveningness Questionnaire, sleepiness will be assessed with the Epworth Sleepiness Scale, sleep quality will be measured using the Pittsburgh Sleep Quality Index, fatigue levels will be evaluated using the Fatigue Severity Scale, and quality of life will be assessed with the CONTILIFE Questionnaire.

3 Incontinence Questions (3IQ): The 3 Incontinence Questions is a simple, repeatable survey used to determine the type of urinary incontinence. It classifies the patient into stress, urge, mixed, or other types based on the most common situation in which they experience urinary leakage over the last three months. The 3 Incontinence Questions is an open-access form that does not require permission for use.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Group with nocturia

Women who experience urinary incontinence and have nocturia.

Group without nocturia

Women who experience urinary incontinence but do not have nocturia.

结局指标

主要结局

Assessment of Symptoms

时间窗: from January 2025 to March 2025

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.

次要结局

  • Assessment of Symptoms(from January 2025 to March 2025)
  • Assessment of Sleepiness(from January 2025 to March 2025)
  • Assessment of Quality of life(from January 2025 to March 2025)
  • Assessment of Chronotype(from January 2025 to March 2025)
  • Assessment of Sleep Quality(from January 2025 to April 2025)
  • Assessment of Fatigue(from January 2025 to March 2025)

研究者

发起方
Gulhane School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özge Çoban

Assistant Professor

Gulhane School of Medicine

研究点 (1)

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