CClinicalTrials.gg
RecruitingNCT04433897HARALDUpdated Apr 12, 2024

Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

An observational study in Nocturia, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Nocturia

Browse trials for

03

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women who are biochochemically confirmed to be postmenopausal.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Oral estrogen + IUD

    Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD

    Other: Questionnaire

  • Oral estrogen + hysterectomy

    Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy.

    Other: Questionnaire

  • Oral estrogen + oral progesterone

    Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone.

    Other: Questionnaire

  • Transdermal estrogen + IUD

    Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD.

    Other: Questionnaire

  • Transdermal estrogen + hysterectomy

    Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy.

    Other: Questionnaire

  • Transdermal estrogen + oral progesteron

    Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron

    Other: Questionnaire

  • SERM

    Women who opt to be treated for their postmenopausal symptoms using SERM's

    Other: Questionnaire

  • Aromatase inhibitor

    Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor.

    Other: Questionnaire

  • Duavive

    Women who opt to be treated for their postmenopausal symptoms using duavive.

    Other: Questionnaire

  • No treatment

    Women who opt not to be treated for their postmenopausal symptoms.

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

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

05

What researchers measure

Primary outcomes

  1. Change in nocturnal Frequency

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

    Time frame: 6 months after initiating therapy

Secondary outcomes

  1. Change in bother linked with nocturnal frequency

    Change in VAS scale of bother linked with nocturnal frequency

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Department of Urology, Ghent University
    Gent, Oost-Vlaanderen 9000, Belgium
    • Kim Pauwaert, MD · Contact · kim.pauwaert@uzgent.be · +32 93321182
    • An-Sofie Goessaert, MD, PhD · Contact
    • Kim Pauwaert, MD · Principal investigator
    • An-Sofie Goessaert, MD, PhD · Principal investigator
    • Karel Everaert, MD, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04433897
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Jun 16, 2020
Start date
Jun 1, 2018
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 12, 2024

Study contacts

Kim Pauwaert
Contact
kim.pauwaert@ugent.be
093321182
Karel Everaert
Contact
Karel.Everaert@uzgent.be

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion