Hormonal Influences on Diuresis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04891926

Acronym

HODI

Enrollment

Registered

2021-05-19

Start date

2015-05-01

Completion date

2018-09-30

Last updated

2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia, Menopause, LUTS, Diuresis

Brief summary

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

Interventions

DIAGNOSTIC_TESTICIQ FLUTS Questionaires

Questionnaire observing the impact on voiding disfunctions

DIAGNOSTIC_TESTFrequency Volume Chart

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

DIAGNOSTIC_TESTRenal Function Profile

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.

DIAGNOSTIC_TESTBlood Analysis

Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc)

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Change of HT on nocturnal frequency	6 months	Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026