Hormonal Influences on Diuresis

Study Overview
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Brief Summary
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The aim of this study was to observe the effect of hormonal treatment (oral or transdermal substitution therapy) on diuresis (salt and water diuresis) and lower urinary tract symptoms (LUTS) in postmenopausal women

Official Title
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Influence of Hormonale Changes on Diuresis and LUTS in the Gynaecological Population

Conditions
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Nocturia, Menopause, LUTS, Diuresis

Intervention / Treatment
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* Diagnostic Test: ICIQ FLUTS Questionaires
* Diagnostic Test: Frequency Volume Chart
* Diagnostic Test: Renal Function Profile
* Diagnostic Test: Blood Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 40 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hormonal therapy<br>Patients choosing to start hormoanl treatment using ural or transdermal estrogen. | Diagnostic Test: ICIQ FLUTS Questionaires<br>* Questionnaire observing the impact on voiding disfunctions<br>Diagnostic Test: Frequency Volume Chart<br>* Frequency Volume Chart measures the voided volumes and fluid intake during 3 days in order to observe patients bladder capacity, total and nighttime voided volume and voiding frequency<br>Diagnostic Test: Renal Function Profile<br>* The RFP is a 24-hour urine analysis in which urine samples are collected at fixed time points every 3 hours, starting 3 hours after the first morning void. This RFP was collected on a separated day to the FVC. Daytime samples were taken between 10:00-11:30 (U1), 13:00-15:30 (U2), 16:00-17:30 (U3), 19:00-20:30 (U4), and 22:00-23:30 (U5). The night-time samples were taken between 1:00-2:30 (U6), 4:00-5:30 (U7) and 7:00-8:30 (U8), and the volume of each interim void, was noted to calculate the 24h, daytime and night-time urine volume and diuresis rate. On each of this 8 samples, creatinine, osmolality, sodium and urea concentration were analysed. Subsequently, the renal clearance of creatinine, solutes, sodium and potassium (Usubst x Uflow / Psubst) and FWC (urine flow - solute clearance) were calculated.<br>Diagnostic Test: Blood Analysis<br>* Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HT on nocturnal frequency | Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on nocturnal urine production | Change of the nocturnal urine production by hormonal treatment by the volume of one micturition (+- 200ml) | 6 months |