Hormonal Influences on Diuresis
HODI
Influence of Hormonale Changes on Diuresis and LUTS in the Gynaecological Population
1 other identifier
interventional
70
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedFirst Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedMay 19, 2021
April 1, 2021
3.4 years
May 4, 2021
May 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change of HT on nocturnal frequency
Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment.
6 months
Secondary Outcomes (1)
Effect on nocturnal urine production
6 months
Study Arms (1)
Hormonal therapy
EXPERIMENTALPatients choosing to start hormoanl treatment using ural or transdermal estrogen.
Interventions
Questionnaire observing the impact on voiding disfunctions
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
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 in order to observ postmenopausal state, osmolalitity and sodium.
Eligibility Criteria
You may qualify if:
- Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Pauwaert K, Bruneel E, Van Laecke E, Depypere H, Everaert K, Goessaert AS. Does hormonal therapy affect the bladder or the kidney in postmenopausal women with and without nocturnal polyuria: Results of a pilot trial? Maturitas. 2022 Jun;160:61-67. doi: 10.1016/j.maturitas.2022.01.009. Epub 2022 Jan 29.
PMID: 35550708DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 19, 2021
Study Start
May 1, 2015
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
May 19, 2021
Record last verified: 2021-04