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Clinical Trials/NCT04433897
NCT04433897
Recruiting
Not Applicable

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

University Hospital, Ghent1 site in 1 country300 target enrollmentJune 1, 2018
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ConditionsNocturia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nocturia
Sponsor
University Hospital, Ghent
Enrollment
300
Locations
1
Primary Endpoint
Change in nocturnal Frequency
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Change in nocturnal Frequency

Time Frame: 6 months after initiating therapy

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

Secondary Outcomes

  • Change in bother linked with nocturnal frequency(6 months)

Study Sites (1)

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