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

NCT06866834 | Recruiting

• 1 other identifier: 2024-556
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Women; Urinary Incontinence (UI); Nocturia

Outcome Measures

Primary Outcomes (5)

• 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.

  from January 2025 to April 2025

• 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.

  from January 2025 to April 2025

• 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.

  from January 2025 to April 2025

• 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."

  from January 2025 to April 2025

• Assessment of Quality of life

  Quality of life will be assessed using the CONTILIFE Questionnaire. The questionnaire is a Likert-type scale consisting of 28 questions and includes six subparameters. Questions 1-7 assess daily activities, questions 8-11 assess effort, questions 12-18 assess self-esteem, questions 19-24 assess emotional impact, questions 25-27 assess sexuality, the 28th question is used to evaluate general quality of life.The total score is determined by summing the scores from all subparameters. As the total score increases, it indicates a poorer quality of life.

  from January 2025 to April 2025

Secondary Outcomes (2)

• Assessment of Sleepiness

  from January 2025 to April 2025

• Assessment of Fatigue

  from January 2025 to April 2025

Study Arms (2)

Group with nocturia

Women who experience urinary incontinence and have nocturia.

Group without nocturia

Women who experience urinary incontinence but do not have nocturia.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gülhane Training and Research Hospital, Department of Obstetrics and Gynecology

You may qualify if:

• 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
• Being 18 years of age or older
• Being female
• Have been diagnosed with urinary incontinence

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

University of Health Sciences Gülhane Faculty of Physiotherapy and Rehabilitation

Ankara, Keçiören, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Nocturia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Özge Özkutlu, Assistant Professor

CONTACT

+90 5301362961; ozge.coban@sbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 10, 2025
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

TU (1)