NCT04433897

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

7.6 years

First QC Date

June 12, 2020

Last Update Submit

April 11, 2024

Conditions

Nocturia

Outcome Measures

Primary Outcomes (1)

  • Change in nocturnal Frequency

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

    6 months after initiating therapy

Secondary Outcomes (1)

  • Change in bother linked with nocturnal frequency

    6 months

Study Arms (10)

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

QuestionnaireOTHER

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

Aromatase inhibitorDuaviveNo treatmentOral estrogen + IUDOral estrogen + hysterectomyOral estrogen + oral progesteroneSERMTransdermal estrogen + IUDTransdermal estrogen + hysterectomyTransdermal estrogen + oral progesteron

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy is specific for postmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who are biochochemically confirmed to be postmenopausal.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Nocturia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Kim Pauwaert

CONTACT

093321182kim.pauwaert@ugent.be

Karel Everaert

CONTACT

Karel.Everaert@uzgent.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 16, 2020

Study Start

June 1, 2018

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations

BE(1)