Skip to content

Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04433897
Acronym
HARALD
Enrollment
300
Registered
2020-06-16
Start date
2018-06-01
Completion date
2025-12-31
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia

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.

Interventions

OTHERQuestionnaire

All women fulfilled 3 questionairres * TANGO * ICIQ -N * Perceived Stress Scale

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in nocturnal Frequency6 months after initiating therapyChange from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire

Secondary

MeasureTime frameDescription
Change in bother linked with nocturnal frequency6 monthsChange in VAS scale of bother linked with nocturnal frequency

Countries

Belgium

Contacts

Primary ContactKim Pauwaert
kim.pauwaert@ugent.be093321182
Backup ContactKarel Everaert
Karel.Everaert@uzgent.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026