Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
NCT ID: NCT04433897
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2018-06-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Oral estrogen + IUD
Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Oral estrogen + hysterectomy
Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy.
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Oral estrogen + oral progesterone
Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone.
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Transdermal estrogen + IUD
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD.
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Transdermal estrogen + hysterectomy
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy.
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Transdermal estrogen + oral progesteron
Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
SERM
Women who opt to be treated for their postmenopausal symptoms using SERM's
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Aromatase inhibitor
Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor.
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Duavive
Women who opt to be treated for their postmenopausal symptoms using duavive.
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
No treatment
Women who opt not to be treated for their postmenopausal symptoms.
Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Interventions
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Questionnaire
All women fulfilled 3 questionairres
* TANGO
* ICIQ -N
* Perceived Stress Scale
Eligibility Criteria
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Inclusion Criteria
* All women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'Stages of Reproductive Aging Workshop' (STRAW) criteria
Exclusion Criteria
* 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.
40 Years
65 Years
FEMALE
Yes
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Locations
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Department of Urology, Ghent University
Ghent, Oost-Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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An-Sofie Goessaert, MD, PhD
Role: backup
Other Identifiers
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EC 2018/0315 (BC-02592)
Identifier Type: -
Identifier Source: org_study_id
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