Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

Study Overview
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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.

Official Title
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Observing the Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

Conditions
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Nocturia

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral estrogen + IUD<br>Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| Oral estrogen + hysterectomy<br>Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy. | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| Oral estrogen + oral progesterone<br>Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone. | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| Transdermal estrogen + IUD<br>Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD. | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| Transdermal estrogen + hysterectomy<br>Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy. | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| Transdermal estrogen + oral progesteron<br>Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| SERM<br>Women who opt to be treated for their postmenopausal symptoms using SERM's | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| Aromatase inhibitor<br>Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor. | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| Duavive<br>Women who opt to be treated for their postmenopausal symptoms using duavive. | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|
| No treatment<br>Women who opt not to be treated for their postmenopausal symptoms. | Other: Questionnaire<br>* All women fulfilled 3 questionairres TANGO ICIQ -N Perceived Stress Scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nocturnal Frequency | Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire | 6 months after initiating therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bother linked with nocturnal frequency | Change in VAS scale of bother linked with nocturnal frequency | 6 months |