Actively Recruiting

Age: 18Years +
FEMALE
ID06866834

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

Led by Gulhane School of Medicine · Updated on 2025-03-10

102

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Urinary incontinence (UI) is the unintentional loss of urine that can negatively affect social, physical, and psychological well-being, reducing quality of life for many women. Nocturia, which is waking during the main sleep period to urinate with the intention to fall back asleep, often occurs alongside UI and also impacts sleep quality, fatigue, and daily functioning. This research aims to investigate how nocturia influences pelvic floor symptoms, chronotype (body's natural timing for activity), sleepiness, sleep quality, fatigue, and quality of life in women experiencing urinary incontinence. The study will observe two groups of women over 18 years old with urinary incontinence: those who experience nocturia and those who do not. Participants will be evaluated using several questionnaires and scales that assess urinary symptoms, pelvic floor distress, chronotype, sleepiness, sleep quality, fatigue, and quality of life. The study excludes women with certain medical conditions or recent treatments that could affect the results, such as sleep disorders, neurological diseases, recent pregnancy, or use of specific medications. During the study period from January to April 2025, participants will provide demographic and medical information and complete validated surveys measuring their urinary symptoms, sleep patterns, chronotype, fatigue, and quality of life. Researchers will track these assessments to understand nocturia's impact on women's health and well-being. The total participation involves these assessments during the planned timeframe, with careful monitoring of symptoms and quality of life outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Diagnosed with urinary incontinence
  • For the group with nocturia: wakes during main sleep period to urinate with intention to fall back asleep
Not Eligible

You will not qualify if you...

  • Diagnosis of 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 childbirth within the last six months
  • Urinary tract infection in the last three months
  • Prolapse greater than stage 2
  • History of orthopedic trauma to pelvic region
  • Pelvic surgery within the last six months
  • History of cancer
  • For the group without nocturia: wakes during main sleep period to urinate with intention to fall back asleep

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 4 months

Participants complete questionnaires and assessments to evaluate urinary incontinence symptoms, pelvic floor distress, chronotype, sleepiness, sleep quality, fatigue, and quality of life.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Approximately 4 months

Participants' symptoms, sleep parameters, and quality of life are observed to understand the effect of nocturia over time.

No additional visits; assessments occur during the diagnostic evaluation period

Trial Site Locations

Total: 1 location

1

University of Health Sciences Gülhane Faculty of Physiotherapy and Rehabilitation

Ankara, Keçiören, Turkey (Türkiye), 06000

Actively Recruiting

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Research Team

Ö

Özge Özkutlu, Assistant Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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