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NCT04891926 Clinical Trial

Hormonal Influences on Diuresis

Menopause Clinical Trial

— HODI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04891926
Other study ID # EC2014/1241
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date September 30, 2018

Study information
Verified date April 2021
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years and older
Eligibility Inclusion Criteria: - Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc) Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ICIQ FLUTS Questionaires
Questionnaire observing the impact on voiding disfunctions
• Frequency 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
• Renal 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.
• Blood Analysis
Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Outcome
Type Measure Description Time frame Safety issue
Primary Change of HT on nocturnal frequency Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment. 6 months
Secondary Effect on nocturnal urine production Change of the nocturnal urine production by hormonal treatment by the volume of one micturition (+- 200ml) 6 months
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