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

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

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