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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
NameTimeMethod
Change in nocturnal Frequency6 months after initiating therapy

Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire

Secondary Outcome Measures
NameTimeMethod
Change in bother linked with nocturnal frequency6 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, Belgium
Kim Pauwaert, MD
Principal Investigator
An-Sofie Goessaert, MD, PhD
Principal Investigator
Karel Everaert, MD, PhD
Principal Investigator

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