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Completed

NCT Number: NCT04891926

Hormonal Influences on Diuresis

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

Completed

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Key information

Conditions

Nocturia Diuresis LUTS Lower Urinary Tract Symptoms Menopause Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

ICIQ FLUTS Questionaires

Diagnostic Test

Questionnaire observing the impact on voiding disfunctions

Frequency Volume Chart

Diagnostic Test

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

Renal Function Profile

Diagnostic Test

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.

Blood analysis

Diagnostic Test

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

Primary outcomes

  1. Change of HT on nocturnal frequency

    Time frame: 6 months

    Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment.

Secondary outcomes

  1. Effect on nocturnal urine production

    Time frame: 6 months

    Change of the nocturnal urine production by hormonal treatment by the volume of one micturition (+- 200ml)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: HODI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 19, 2021
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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