Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
Recruiting
- Conditions
- Nocturia
- Registration Number
- NCT04433897
- Lead Sponsor
- University Hospital, Ghent
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in nocturnal Frequency 6 months after initiating therapy Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire
- Secondary Outcome Measures
Name Time Method Change in bother linked with nocturnal frequency 6 months Change in VAS scale of bother linked with nocturnal frequency
Trial Locations
- Locations (1)
Department of Urology, Ghent University
🇧🇪Gent, Oost-Vlaanderen, Belgium
Department of Urology, Ghent University🇧🇪Gent, Oost-Vlaanderen, BelgiumKim Pauwaert, MDPrincipal InvestigatorAn-Sofie Goessaert, MD, PhDPrincipal InvestigatorKarel Everaert, MD, PhDPrincipal Investigator