Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

NCT ID: NCT04433897

Last Updated: 2024-04-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nocturia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Urology, Ghent University

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Kim Pauwaert

Role: CONTACT

093321182

Karel Everaert

Role: CONTACT

Facility Contacts

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Kim Pauwaert, MD

Role: primary

+32 93321182

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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