Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

Recruiting

• Conditions: Nocturia
• Interventions: Other: Questionnaire

• Registration Number: NCT04433897
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transdermal estrogen + hysterectomy	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy.
Oral estrogen + oral progesterone	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone.
Transdermal estrogen + oral progesteron	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron
Oral estrogen + IUD	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD
SERM	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using SERM's
No treatment	Questionnaire	Women who opt not to be treated for their postmenopausal symptoms.
Oral estrogen + hysterectomy	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy.
Transdermal estrogen + IUD	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD.
Aromatase inhibitor	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor.
Duavive	Questionnaire	Women who opt to be treated for their postmenopausal symptoms using duavive.

Primary Outcome Measures

Name	Time	Method
Change in nocturnal Frequency	6 months after initiating therapy	Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in bother linked with nocturnal frequency	6 months	Change in VAS scale of bother linked with nocturnal frequency

Trial Locations

Locations (1)

Department of Urology, Ghent University; 🇧🇪 Gent, Oost-Vlaanderen, Belgium