Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women (HARALD)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Nocturia

Treatments: Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04433897

EC 2018/0315 (BC-02592)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

300 participants in 10 patient groups

Oral estrogen + IUD

Description:

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

Treatment:

Other: Questionnaire

Oral estrogen + hysterectomy

Description:

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

Treatment:

Other: Questionnaire

Oral estrogen + oral progesterone

Description:

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

Treatment:

Other: Questionnaire

Transdermal estrogen + IUD

Description:

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

Treatment:

Other: Questionnaire

Transdermal estrogen + hysterectomy

Description:

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

Treatment:

Other: Questionnaire

Transdermal estrogen + oral progesteron

Description:

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

Treatment:

Other: Questionnaire

SERM

Description:

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

Treatment:

Other: Questionnaire

Aromatase inhibitor

Description:

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

Treatment:

Other: Questionnaire

Duavive

Description:

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

Treatment:

Other: Questionnaire

No treatment

Description:

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

Treatment:

Other: Questionnaire