Examining how nocturia affects pelvic floor symptoms and quality of life in women with urinary incontinence
Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Chronotype, Sleepiness, Sleep Quality, Fatigue and Quality of Life in Women with Urinary Incontinence
This study looks at how nighttime urination affects pelvic floor symptoms and quality of life for women who have urinary incontinence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Gulhane School of Medicine Academic / other |
| Locations | 1 site (Ankara, Keçiören) |
| Trial ID | NCT06866834 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between nocturia and its impact on pelvic floor symptoms, sleep parameters, and overall quality of life in women diagnosed with urinary incontinence. Participants will be categorized into two groups: those experiencing nocturia and those who do not. The study aims to understand how nocturia, characterized by nighttime urination, affects sleep quality and pelvic floor health. By analyzing these factors, the research seeks to provide insights into the comprehensive effects of nocturia on women's health.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who have been diagnosed with urinary incontinence and experience nocturia.
Not a fit: Patients who have sleep disorders, neurological diseases, chronic kidney disease, diabetes, or are on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for women suffering from urinary incontinence and nocturia, enhancing their quality of life.
How similar studies have performed: While the relationship between nocturia and quality of life has been explored, this specific observational approach focusing on pelvic floor symptoms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Ankara, Keçiören
- University of Health Sciences Gülhane Faculty of Physiotherapy and Rehabilitation — Ankara, Keçiören, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Özge Özkutlu, Assistant Professor
- Email: ozge.coban@sbu.edu.tr
- Phone: +90 5301362961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.