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NCT04433897 Clinical Trial

Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

Nocturia Clinical Trial

— HARALD  

Official title:
Observing the Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04433897
Other study ID # EC 2018/0315 (BC-02592)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2025

Study information
Verified date April 2024
Source University Hospital, Ghent
Contact Kim Pauwaert
Phone 093321182
Email kim.pauwaert@ugent.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim of this study was to observe The study was adjusted in two parts: PART 1 is a crossectional study in which the prevalance, risk factors and etiology of nocturia among postmenopausal women is assessed. PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies on nocturia.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale

Locations
Country Name City State
Belgium Department of Urology, Ghent University Gent Oost-Vlaanderen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in nocturnal Frequency Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire 6 months after initiating therapy
Secondary Change in bother linked with nocturnal frequency Change in VAS scale of bother linked with nocturnal frequency 6 months
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