Examining hormonal therapy effects on nighttime urination in postmenopausal women
Observing the Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
This study is testing how different hormonal therapies can help postmenopausal women who frequently wake up at night to urinate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Gent, Oost-Vlaanderen) |
| Trial ID | NCT04433897 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prevalence, risk factors, and causes of nocturia in postmenopausal women through a cross-sectional analysis. It also includes a cohort component that evaluates the effects of ten different hormonal replacement therapies on nocturia symptoms. Participants will complete questionnaires to provide data on their experiences and symptoms. The study aims to enhance understanding of how hormonal changes impact nocturia in this population.
Who should consider this trial
Good fit: Ideal candidates are women experiencing postmenopausal symptoms who are in the early stages of menopause.
Not a fit: Patients currently on hormonal replacement therapy or those with certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for nocturia in postmenopausal women.
How similar studies have performed: While there is limited data on this specific approach, similar studies have explored hormonal impacts on urinary symptoms, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with postmenopausal symptoms (hot flushes, atrophy, ..) * All women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'Stages of Reproductive Aging Workshop' (STRAW) criteria Exclusion Criteria: * Intake of HRT on the moment of inclusion * women with thyroid dysfunction * women using antihypertensive agents * women with a history of psychiatric or neurological disorders * women with a history of alcohol or drug addiction.
Where this trial is running
Gent, Oost-Vlaanderen
- Department of Urology, Ghent University — Gent, Oost-Vlaanderen, Belgium (Recruiting)
Study contacts
- Study coordinator: Kim Pauwaert
- Email: kim.pauwaert@ugent.be
- Phone: 093321182
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.